David Pearlman - Academia.edu (original) (raw)

Papers by David Pearlman

Research paper thumbnail of Pathogenesis, prevalence, diagnosis, and management of exercise-induced bronchoconstriction: a practice parameter

Annals of Allergy, Asthma & Immunology, 2010

... UCB, Wallace, Dey, Sciele, Baxter, Accredo, Critical Care, Genentech/ Novartis, Sepracor, Med... more ... UCB, Wallace, Dey, Sciele, Baxter, Accredo, Critical Care, Genentech/ Novartis, Sepracor, Meda, Sanofi-Aventis, TEVA, Pfizer, and Verus. ... Force acknowledges the following individuals who also contributed substantially to the creation of this parameter: Erin Shae Johns, PhD ...

Research paper thumbnail of Pathogenesis, prevalence, diagnosis, and management of exercise-induced bronchoconstriction: a practice parameter

Annals of Allergy, Asthma & Immunology, 2010

... UCB, Wallace, Dey, Sciele, Baxter, Accredo, Critical Care, Genentech/ Novartis, Sepracor, Med... more ... UCB, Wallace, Dey, Sciele, Baxter, Accredo, Critical Care, Genentech/ Novartis, Sepracor, Meda, Sanofi-Aventis, TEVA, Pfizer, and Verus. ... Force acknowledges the following individuals who also contributed substantially to the creation of this parameter: Erin Shae Johns, PhD ...

Research paper thumbnail of Fluticasone furoate/vilanterol versus fluticasone propionate in patients with asthma and exercise-induced bronchoconstriction

Research paper thumbnail of Mometasone Furoate Nasal Spray Improves Nasal and Ocular Symptoms of Seasonal Allergic Rhinitis in Adolescent Patients

J Allerg Clin Immunol, 2007

RATIONALE: Mometasone furoate nasal spray (MFNS) is effective in controlling the nasal symptoms o... more RATIONALE: Mometasone furoate nasal spray (MFNS) is effective in controlling the nasal symptoms of seasonal allergic rhinitis (SAR). A reanalysis of patient-reported symptom data in MFNS trials was performed to determine its impact on ocular symptoms. METHODS: Ocular symptom data were pooled from 4 randomized, double-blind, placebo-controlled, phase III clinical studies (three 2-week; one 4-week); these studies followed similar protocols which compared the effectiveness of MFNS 200 mcg qd and placebo in controlling ocular symptoms in patients aged 12 years with a 2-year history of SAR (N5983). Individual sign/symptom scores for eye tearing, itching, and redness were evaluated on a 4-point scale (05none; 35severe), and a total ocular symptom score (TOSS) was calculated. RESULTS: The mean baseline TOSS was 4.35 for the MFNS group and 4.5 for the placebo group. The MFNS group (n5491) showed greater decreases in TOSS than the placebo group (n5492) starting at Day 2, first reaching statistical significance at Day 3. The decrease with MFNS for the Day 1-15 interval was 19.8% vs 5.6% for placebo (P<0.001). For the same time period, the scores for tearing decreased by 22.2% with MFNS vs a decrease of 3.9% with placebo (P<0.001), for eye itching by 17.3% with MFNS vs 12.3% with placebo (P50.002), and for redness by 15.7% with MFNS vs 8.3% with placebo (P50.002). CONCLUSIONS: MFNS successfully reduced ocular symptoms of SAR. The effects of MFNS on these ocular symptoms are consistent with results reported with other intranasal steroids. Funding: Schering-Plough

Research paper thumbnail of Twenty-six-week efficacy and safety study of mometasone furoate/formoterol 200/10 μg combination treatment in patients with persistent asthma previously receiving medium-dose inhaled corticosteroids

Allergy and Asthma Proceedings, 2010

Asthma is a heterogeneous condition characterized by reduced lung function, chronic inflammation,... more Asthma is a heterogeneous condition characterized by reduced lung function, chronic inflammation, and periodic asthma deteriorations. This study was performed to evaluate the effect of mometasone furoate (MF)/formoterol (F) combination, 200/10 microg, administered twice daily (b.i.d.) on asthma deteriorations and pulmonary function in patients with asthma uncontrolled on medium-dose inhaled corticosteroid (ICS). After 2- to 3-week open-label run-in with MF 200 microg b.i.d., patients (&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;or=12 years) were randomized to 26 weeks of treatment with MF/F 200/10 microg, MF 200 microg, F 10 microg, or placebo b.i.d. Coprimary end points were time to first asthma deterioration (MF/F versus F) and bronchodilation, assessed by the area under the curve of the change in forced expiratory volume in 1 second 0-12 hours (FEV(1) AUC(0-12h); MF/F versus MF). A total of 781 patients were randomized. Treatment with MF/F 200/10 microg reduced asthma deteriorations and clinically judged deteriorations (i.e., deterioration resulting in emergency treatment, hospitalization, or treatment with additional excluded asthma medication [i.e., systemic corticosteroids]). The proportion of patients experiencing asthma deteriorations was MF/F, 30.4%; MF, 33.9%; F, 54.0%; placebo, 55.6% (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001, MF/F versus F and placebo). There was a sixfold reduction in clinically judged deteriorations with MF/F versus F and placebo (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001). Lung function improved more rapidly with MF/F than MF and placebo. Mean change from baseline FEV(1) AUC(0-12h) at week 12 was MF/F, 11.7% versus MF, 5.7%; F, 8.5%; and placebo, 3.9% (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001). Treatment-related AEs were rare and similar across groups. Treatment with MF/F 200/10 microg was effective in reducing the risk of asthma deteriorations. MF/F was safe and provided rapid and sustained bronchodilation in patients with asthma.

Research paper thumbnail of The Effect of Adjuvant Amounts of Endotoxins on the Serum Hemolytic Complement Activity in Rabbits

The Journal of Immunology, Dec 1, 1963

Page 1. of December 2, 2010 This information is current as 1963;91;748-756 J Immunol and David W.... more Page 1. of December 2, 2010 This information is current as 1963;91;748-756 J Immunol and David W. Talmage David S. Pearlman, James B. Sauers Rabbits Complement Activity in the Serum Hemolytic Amounts of Endotoxins on The Effect of Adjuvant Subscriptions ...

Research paper thumbnail of Safety of long-acting β-agonist (LABA) withdrawal in patients in two clinical asthma trials

European Respiratory Journal, Sep 1, 2012

Research paper thumbnail of Cetirizine in patients with seasonal rhinitis and concomitant asthma: prospective, randomized, placebo-controlled trial

The Journal of Allergy and Clinical Immunology, May 1, 1995

Objective: This study explored the safety and e~cacy of cetirizine for treatment of allergic rhin... more Objective: This study explored the safety and e~cacy of cetirizine for treatment of allergic rhinitis and asthma. Methods: Daily treatment for 6 weeks with cetirizine 10 mg (93 patients) was compared with placebo treatment (93 patients) in a randomized, double-blind parallel study of patients with allergic rhinitis and asthma. This multicenter study was started just before onset of the fall pollen season. Rhinitis and asthma symptoms were assessed twice daily; spirometry was performed weekly. Results: Placebo-treated patients experienced a worsening of rhinitis symptoms from baseline throughout the study, whereas cetirizine-treated patients had a significant improvement in rhinitis symptoms at week 1, which was maintained after onset of the pollen season. Asthma symptoms in the cetirizine group improved from baseline at week 1; symptoms were significan#y better than in the placebo group for 5 of 6 weeks of the study. Pulmonary function did not worsen in patients taking cetifizine or placebo; there were no differences between treatments as determined by spiromeoy. Albuterol use was less frequent in the cetirizine-treated patients for every week of the study, but differences did not reach significance. Pseudoephedrine use was similar in both groups. More cetirizine-treated patients (90%) completed the trial than did placebo-treated patients (74%). Both treatments were well tolerated. Conclusion: Cetirizine 10 mg daily is safe and effective in relieving both upper and lower respiratory tract symptoms in patients with seasonal allergic rhinitis and concomitant asthma. (]ALLERGY CL [N IMMUNOL 1995;95:923-32.)

Research paper thumbnail of Efficacy and Safety of Ketorolac Tromethamine 0.5% and Levocabastine 0.05%: A Multicenter Comparison in Patients With Seasonal Allergic Conjunctivitis

Advan Ther, 2000

This multicenter, double-masked, randomized, parallel-group study compared the efficacy and safet... more This multicenter, double-masked, randomized, parallel-group study compared the efficacy and safety of ketorolac tromethamine 0.5% ophthalmic solution with levocabastine 0.05% and ketorolac tromethamine vehicle in patients with seasonal allergic conjunctivitis. One drop of ketorolac, levocabastine, or vehicle was instilled in each eye four times daily for 6 weeks. In the majority of efficacy variables, ketorolac produced the greatest improvements, followed by levocabastine and vehicle. Ketorolac was significantly more effective (P &lt; .05) than vehicle in reducing mean itching scores, palpebral hyperemia, bulbar hyperemia, and edema. Patients treated with ketorolac reported significant improvements (P &lt; .05) in their ability to sleep and to concentrate on work, compared with those who received vehicle. No significant differences were noted among the treatment groups in safety or tolerability. Ketorolac tromethamine 0.5% ophthalmic solution instilled four times daily is effective and safe in reducing the signs and symptoms of seasonal allergic conjunctivitis.

Research paper thumbnail of Prevention of exercise-induced bronchospasm in pediatric asthma patients: a comparison of salmeterol powder with albuterol

Annals of Allergy Asthma Immunology Official Publication of the American College of Allergy Asthma Immunology, Jan 2, 1999

Background: Exercise-induced bronchospasm (EIB) is a common problem in children with asthma. Pret... more Background: Exercise-induced bronchospasm (EIB) is a common problem in children with asthma. Pretreatment with the beta 2 (␤ 2 )-adrenoreceptor agonist albuterol is effective for preventing EIB, but is recognized as providing only short-term (2 to 3 hour) protection.

Research paper thumbnail of Time to onset of effect of fluticasone propionate in patients with asthma

Data Revues 00916749 V103i5 S0091674999704203, Aug 9, 2011

The effectiveness of inhaled glucocorticoids in the treatment of asthma is well documented; howev... more The effectiveness of inhaled glucocorticoids in the treatment of asthma is well documented; however, times to onset and maximal treatment effects of these agents have been poorly described. We sought to determine the time to onset of effect and the time to the best observed effect of inhaled fluticasone propionate (FP) in patients with asthma. Data from 8 randomized, double-blind, placebo-controlled clinical trials of at least 8 weeks&#39; duration were analyzed. Corticosteroid-naive patients (n = 1461) were treated with either FP (25 micrograms to 500 micrograms) or placebo twice daily. Efficacy evaluations included morning peak expiratory flow (PEF), asthma symptom scores, supplemental albuterol use, and FEV1. Statistically significant improvements in PEF, asthma symptom scores, and supplemental albuterol use were observed beginning on day 1 of treatment in the FP group versus the placebo group (P &lt;.001); significant increases in FEV1 were observed at the first measurement at week 1 (P &lt;.001). The best observed effect occurred within 3 weeks of the start of FP treatment for PEF (+36 L/min) and FEV1 (+0.52 L) and within 2 weeks for reduction in supplemental albuterol use and asthma symptom scores. Patients with the most severe airflow obstruction had the greatest change in PEF (+56 L/min) and fastest time to 50% of best observed effect (3 days) compared with patients with mild or moderate airflow obstruction; however, time to best observed effect was similar in the 3 groups (20 to 27 days). In patients with asthma, the onset of significant benefit of FP on PEF, symptoms, and rescue albuterol use occurred within 1 day of the start of therapy. FEV1 improved within 1 week of the start of therapy (the first measurement after randomization). There was no effect of sex, age, or dose of FP on the time to response. The best observed response in PEF varies with the degree of baseline airflow obstruction; however, the degree of airflow obstruction has no effect on the time to best observed response.

Research paper thumbnail of Efficacy and Safety of Fluticasone Propionate/Salmeterol HFA 134A MDI in Patients with Mild‐to‐Moderate Persistent Asthma

The objective of this study was to compare the efficacy and safety of fluticasone propionate (FP)... more The objective of this study was to compare the efficacy and safety of fluticasone propionate (FP) (44 microg)/salmeterol (21 microg) delivered as two inhalations twice daily via a single hydrofluoroalkane (HFA 134a) metered dose inhaler (MDI) (FSC) with that of placebo HFA 134a (PLA), fluticasone propionate 44 microg chlorofluorocarbon (CFC) alone and salmeterol 21 microg CFC alone (S) in patients (n=360) with persistent asthma previously treated with beta2-agonists (short- or long-acting) or inhaled corticosteroids (ICS). After 12 weeks of treatment, patients treated with FSC had a significantly greater increase (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; or = 0.006) in mean FEV1 AUC(bl) compared with PLA, FP, or S. At end point, mean change from baseline in morning predose FEV1 for FSC (0.58 L) was significantly (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; or = 0.004) greater than PLA (0.14 L), FP (0.36 L), and S (0.25 L). Patients treated with FSC also had a significantly higher probability of remaining in the study without being withdrawn due to worsening asthma (2%) compared with those in the PLA (29%) and S (25%) groups (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001). Finally, treatment with FSC resulted in significantly (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; or = 0.007) greater improvements in morning and evening peak expiratory flow, need for rescue albuterol, and asthma symptom scores compared with FP, S, and PLA. The safety profile of FSC was also similar to FP or S alone. Initial maintenance treatment of the two main components of asthma, inflammation, and smooth muscle dysfunction (e.g., bronchoconstriction), with FSC results in greater overall improvements in asthma control compared with treatment of either individual component alone.

Research paper thumbnail of Short-term and long-term asthma control in patients with mild persistent asthma receiving montelukast or fluticasone: A randomized controlled trial

Data Revues 00916749 V115i2ss S0091674904038692, Aug 18, 2011

To determine whether montelukast is as effective as fluticasone in controlling mild persistent as... more To determine whether montelukast is as effective as fluticasone in controlling mild persistent asthma as determined by rescue-free days. SUBJECTS AND METHODS: Participants aged 15 to 85 years with mild persistent asthma (n ϭ 400) were randomized to oral montelukast (10 mg once nightly) or inhaled fluticasone (88 g twice daily) in a year-long, parallel-group, multicenter study with a 12-week, double-blind period, followed by a 36-week, open-label period.

Research paper thumbnail of Corticosteroids in the Treatment of Allergic Rhinitis

Immunology and Allergy Clinics of North America, Jan 11, 1999

Research paper thumbnail of Fluticasone propionate/formoterol fumarate combination therapy has superior efficacy to both fluticasone and formoterol alone

European Respiratory Journal, Sep 1, 2011

Research paper thumbnail of More Concerning Asthma and Exercise

Research paper thumbnail of Long-acting β2-agonist salmeterol compared with albuterol in maintenance asthma therapy

Annals of Allergy Asthma Immunology, 1995

Research paper thumbnail of Effect of Mometasone Furoate/Formoterol (MF/F) Combination Therapy on Nocturnal Awakenings in Subjects With Persistent Asthma

J Allerg Clin Immunol, 2010

Research paper thumbnail of Formoterol Delivered via a Dry Powder Inhaler (Aerolizer*): Results from Long-term Clinical Trials in Children

Current Medical Research and Opinion, Feb 1, 2002

Over 500 children with asthma, aged 5-12 years, have been treated with formoterol fumarate (Forad... more Over 500 children with asthma, aged 5-12 years, have been treated with formoterol fumarate (Foradil) delivered via the Aerolizer dry powder inhaler in clinical trials, with treatment periods of up to 15 months. In pivotal double-blind trials, two dose levels, 12 and 24 microg taken twice daily, provided significant benefit in terms of lung function measurements and symptom control (a lower dose of 6 microg twice daily appeared insufficient with this formulation). The higher, 24 microg dose appeared to provide an additional margin of benefit in a subgroup of children with more unstable/severe disease when the results from long-term follow-up (12-15 months) were analysed. Formoterol was shown to have a good safety profile when taken as regular maintenance treatment and when used as rescue medication by patients already receiving formoterol as regular maintenance treatment. In this flexible regimen, with formoterol used for rescue and maintenance, the overall daily intake of formoterol was low, with 96.1% of all treatment days (n = 2452) covered by a total daily dose (regular + rescue) of 48 microg (four doses) or less. There was no increase in the average daily intake of rescue formoterol over time. The clinical efficacy associated with this regimen was maintained over time and, in the case of morning peak expiratory flow rate, steadily improved over time. The Foradil Aerolizer inhalation system is simple to use and has a low resistance to inspiratory airflow that maximises the patient&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s control over dosing, while minimising the risk of under- and overdosing. These features may be especially valuable in a young patient population.

Research paper thumbnail of Efficacy and safety of budesonide administered by pressurized metered-dose inhaler in children with asthma

Annals of Allergy, Asthma & Immunology, 2015

Budesonide is approved for delivery using a nebulized solution and dry-powder inhaler, but its us... more Budesonide is approved for delivery using a nebulized solution and dry-powder inhaler, but its use through a pressurized metered-dose inhaler (pMDI) in pediatric patients with asthma has not been determined. To examine the efficacy and safety of 160 μg twice daily of budesonide through a pMDI vs placebo in children 6 to younger than 12 years with asthma and a demonstrated need for inhaled corticosteroids. A 6-week, international, multicenter, double-blinded, parallel-group, phase 2 study randomized 304 pediatric patients (mean age, 9 years; 21.7% &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;8 years) 1:1 to 160 μg (80 μg × 2 inhalations) twice daily of budesonide through a pMDI or placebo after a 7- to 21-day run-in period. The primary efficacy end point was change from baseline in morning peak expiratory flow (PEF); safety end points included adverse events, vital signs, and discontinuations. Budesonide treatment significantly improved morning PEF vs placebo; mean treatment effect (budesonide vs placebo) was 13.6 L/min (P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .0001). Budesonide also showed significant improvements vs placebo for forced expiratory volume in 1 second, evening PEF, forced expiratory flow at 25% to 75% of pulmonary volume, reliever medication use, nighttime awakenings, awakenings with reliever use, and percentage of patients with at least 15- and at least 30-L/min increase in morning PEF from baseline. The numbers of patients experiencing adverse events and discontinuations were smaller in the budesonide than in the placebo group. No serious adverse events were reported. Budesonide at 160 μg twice daily through a pMDI was generally well tolerated and significantly improved lung function, symptoms, rescue medication use, and nighttime awakenings vs placebo in children 6 to younger than 12 years with asthma and a demonstrated need for inhaled corticosteroids.

Research paper thumbnail of Pathogenesis, prevalence, diagnosis, and management of exercise-induced bronchoconstriction: a practice parameter

Annals of Allergy, Asthma & Immunology, 2010

... UCB, Wallace, Dey, Sciele, Baxter, Accredo, Critical Care, Genentech/ Novartis, Sepracor, Med... more ... UCB, Wallace, Dey, Sciele, Baxter, Accredo, Critical Care, Genentech/ Novartis, Sepracor, Meda, Sanofi-Aventis, TEVA, Pfizer, and Verus. ... Force acknowledges the following individuals who also contributed substantially to the creation of this parameter: Erin Shae Johns, PhD ...

Research paper thumbnail of Pathogenesis, prevalence, diagnosis, and management of exercise-induced bronchoconstriction: a practice parameter

Annals of Allergy, Asthma & Immunology, 2010

... UCB, Wallace, Dey, Sciele, Baxter, Accredo, Critical Care, Genentech/ Novartis, Sepracor, Med... more ... UCB, Wallace, Dey, Sciele, Baxter, Accredo, Critical Care, Genentech/ Novartis, Sepracor, Meda, Sanofi-Aventis, TEVA, Pfizer, and Verus. ... Force acknowledges the following individuals who also contributed substantially to the creation of this parameter: Erin Shae Johns, PhD ...

Research paper thumbnail of Fluticasone furoate/vilanterol versus fluticasone propionate in patients with asthma and exercise-induced bronchoconstriction

Research paper thumbnail of Mometasone Furoate Nasal Spray Improves Nasal and Ocular Symptoms of Seasonal Allergic Rhinitis in Adolescent Patients

J Allerg Clin Immunol, 2007

RATIONALE: Mometasone furoate nasal spray (MFNS) is effective in controlling the nasal symptoms o... more RATIONALE: Mometasone furoate nasal spray (MFNS) is effective in controlling the nasal symptoms of seasonal allergic rhinitis (SAR). A reanalysis of patient-reported symptom data in MFNS trials was performed to determine its impact on ocular symptoms. METHODS: Ocular symptom data were pooled from 4 randomized, double-blind, placebo-controlled, phase III clinical studies (three 2-week; one 4-week); these studies followed similar protocols which compared the effectiveness of MFNS 200 mcg qd and placebo in controlling ocular symptoms in patients aged 12 years with a 2-year history of SAR (N5983). Individual sign/symptom scores for eye tearing, itching, and redness were evaluated on a 4-point scale (05none; 35severe), and a total ocular symptom score (TOSS) was calculated. RESULTS: The mean baseline TOSS was 4.35 for the MFNS group and 4.5 for the placebo group. The MFNS group (n5491) showed greater decreases in TOSS than the placebo group (n5492) starting at Day 2, first reaching statistical significance at Day 3. The decrease with MFNS for the Day 1-15 interval was 19.8% vs 5.6% for placebo (P<0.001). For the same time period, the scores for tearing decreased by 22.2% with MFNS vs a decrease of 3.9% with placebo (P<0.001), for eye itching by 17.3% with MFNS vs 12.3% with placebo (P50.002), and for redness by 15.7% with MFNS vs 8.3% with placebo (P50.002). CONCLUSIONS: MFNS successfully reduced ocular symptoms of SAR. The effects of MFNS on these ocular symptoms are consistent with results reported with other intranasal steroids. Funding: Schering-Plough

Research paper thumbnail of Twenty-six-week efficacy and safety study of mometasone furoate/formoterol 200/10 μg combination treatment in patients with persistent asthma previously receiving medium-dose inhaled corticosteroids

Allergy and Asthma Proceedings, 2010

Asthma is a heterogeneous condition characterized by reduced lung function, chronic inflammation,... more Asthma is a heterogeneous condition characterized by reduced lung function, chronic inflammation, and periodic asthma deteriorations. This study was performed to evaluate the effect of mometasone furoate (MF)/formoterol (F) combination, 200/10 microg, administered twice daily (b.i.d.) on asthma deteriorations and pulmonary function in patients with asthma uncontrolled on medium-dose inhaled corticosteroid (ICS). After 2- to 3-week open-label run-in with MF 200 microg b.i.d., patients (&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt;or=12 years) were randomized to 26 weeks of treatment with MF/F 200/10 microg, MF 200 microg, F 10 microg, or placebo b.i.d. Coprimary end points were time to first asthma deterioration (MF/F versus F) and bronchodilation, assessed by the area under the curve of the change in forced expiratory volume in 1 second 0-12 hours (FEV(1) AUC(0-12h); MF/F versus MF). A total of 781 patients were randomized. Treatment with MF/F 200/10 microg reduced asthma deteriorations and clinically judged deteriorations (i.e., deterioration resulting in emergency treatment, hospitalization, or treatment with additional excluded asthma medication [i.e., systemic corticosteroids]). The proportion of patients experiencing asthma deteriorations was MF/F, 30.4%; MF, 33.9%; F, 54.0%; placebo, 55.6% (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001, MF/F versus F and placebo). There was a sixfold reduction in clinically judged deteriorations with MF/F versus F and placebo (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001). Lung function improved more rapidly with MF/F than MF and placebo. Mean change from baseline FEV(1) AUC(0-12h) at week 12 was MF/F, 11.7% versus MF, 5.7%; F, 8.5%; and placebo, 3.9% (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001). Treatment-related AEs were rare and similar across groups. Treatment with MF/F 200/10 microg was effective in reducing the risk of asthma deteriorations. MF/F was safe and provided rapid and sustained bronchodilation in patients with asthma.

Research paper thumbnail of The Effect of Adjuvant Amounts of Endotoxins on the Serum Hemolytic Complement Activity in Rabbits

The Journal of Immunology, Dec 1, 1963

Page 1. of December 2, 2010 This information is current as 1963;91;748-756 J Immunol and David W.... more Page 1. of December 2, 2010 This information is current as 1963;91;748-756 J Immunol and David W. Talmage David S. Pearlman, James B. Sauers Rabbits Complement Activity in the Serum Hemolytic Amounts of Endotoxins on The Effect of Adjuvant Subscriptions ...

Research paper thumbnail of Safety of long-acting β-agonist (LABA) withdrawal in patients in two clinical asthma trials

European Respiratory Journal, Sep 1, 2012

Research paper thumbnail of Cetirizine in patients with seasonal rhinitis and concomitant asthma: prospective, randomized, placebo-controlled trial

The Journal of Allergy and Clinical Immunology, May 1, 1995

Objective: This study explored the safety and e~cacy of cetirizine for treatment of allergic rhin... more Objective: This study explored the safety and e~cacy of cetirizine for treatment of allergic rhinitis and asthma. Methods: Daily treatment for 6 weeks with cetirizine 10 mg (93 patients) was compared with placebo treatment (93 patients) in a randomized, double-blind parallel study of patients with allergic rhinitis and asthma. This multicenter study was started just before onset of the fall pollen season. Rhinitis and asthma symptoms were assessed twice daily; spirometry was performed weekly. Results: Placebo-treated patients experienced a worsening of rhinitis symptoms from baseline throughout the study, whereas cetirizine-treated patients had a significant improvement in rhinitis symptoms at week 1, which was maintained after onset of the pollen season. Asthma symptoms in the cetirizine group improved from baseline at week 1; symptoms were significan#y better than in the placebo group for 5 of 6 weeks of the study. Pulmonary function did not worsen in patients taking cetifizine or placebo; there were no differences between treatments as determined by spiromeoy. Albuterol use was less frequent in the cetirizine-treated patients for every week of the study, but differences did not reach significance. Pseudoephedrine use was similar in both groups. More cetirizine-treated patients (90%) completed the trial than did placebo-treated patients (74%). Both treatments were well tolerated. Conclusion: Cetirizine 10 mg daily is safe and effective in relieving both upper and lower respiratory tract symptoms in patients with seasonal allergic rhinitis and concomitant asthma. (]ALLERGY CL [N IMMUNOL 1995;95:923-32.)

Research paper thumbnail of Efficacy and Safety of Ketorolac Tromethamine 0.5% and Levocabastine 0.05%: A Multicenter Comparison in Patients With Seasonal Allergic Conjunctivitis

Advan Ther, 2000

This multicenter, double-masked, randomized, parallel-group study compared the efficacy and safet... more This multicenter, double-masked, randomized, parallel-group study compared the efficacy and safety of ketorolac tromethamine 0.5% ophthalmic solution with levocabastine 0.05% and ketorolac tromethamine vehicle in patients with seasonal allergic conjunctivitis. One drop of ketorolac, levocabastine, or vehicle was instilled in each eye four times daily for 6 weeks. In the majority of efficacy variables, ketorolac produced the greatest improvements, followed by levocabastine and vehicle. Ketorolac was significantly more effective (P &lt; .05) than vehicle in reducing mean itching scores, palpebral hyperemia, bulbar hyperemia, and edema. Patients treated with ketorolac reported significant improvements (P &lt; .05) in their ability to sleep and to concentrate on work, compared with those who received vehicle. No significant differences were noted among the treatment groups in safety or tolerability. Ketorolac tromethamine 0.5% ophthalmic solution instilled four times daily is effective and safe in reducing the signs and symptoms of seasonal allergic conjunctivitis.

Research paper thumbnail of Prevention of exercise-induced bronchospasm in pediatric asthma patients: a comparison of salmeterol powder with albuterol

Annals of Allergy Asthma Immunology Official Publication of the American College of Allergy Asthma Immunology, Jan 2, 1999

Background: Exercise-induced bronchospasm (EIB) is a common problem in children with asthma. Pret... more Background: Exercise-induced bronchospasm (EIB) is a common problem in children with asthma. Pretreatment with the beta 2 (␤ 2 )-adrenoreceptor agonist albuterol is effective for preventing EIB, but is recognized as providing only short-term (2 to 3 hour) protection.

Research paper thumbnail of Time to onset of effect of fluticasone propionate in patients with asthma

Data Revues 00916749 V103i5 S0091674999704203, Aug 9, 2011

The effectiveness of inhaled glucocorticoids in the treatment of asthma is well documented; howev... more The effectiveness of inhaled glucocorticoids in the treatment of asthma is well documented; however, times to onset and maximal treatment effects of these agents have been poorly described. We sought to determine the time to onset of effect and the time to the best observed effect of inhaled fluticasone propionate (FP) in patients with asthma. Data from 8 randomized, double-blind, placebo-controlled clinical trials of at least 8 weeks&#39; duration were analyzed. Corticosteroid-naive patients (n = 1461) were treated with either FP (25 micrograms to 500 micrograms) or placebo twice daily. Efficacy evaluations included morning peak expiratory flow (PEF), asthma symptom scores, supplemental albuterol use, and FEV1. Statistically significant improvements in PEF, asthma symptom scores, and supplemental albuterol use were observed beginning on day 1 of treatment in the FP group versus the placebo group (P &lt;.001); significant increases in FEV1 were observed at the first measurement at week 1 (P &lt;.001). The best observed effect occurred within 3 weeks of the start of FP treatment for PEF (+36 L/min) and FEV1 (+0.52 L) and within 2 weeks for reduction in supplemental albuterol use and asthma symptom scores. Patients with the most severe airflow obstruction had the greatest change in PEF (+56 L/min) and fastest time to 50% of best observed effect (3 days) compared with patients with mild or moderate airflow obstruction; however, time to best observed effect was similar in the 3 groups (20 to 27 days). In patients with asthma, the onset of significant benefit of FP on PEF, symptoms, and rescue albuterol use occurred within 1 day of the start of therapy. FEV1 improved within 1 week of the start of therapy (the first measurement after randomization). There was no effect of sex, age, or dose of FP on the time to response. The best observed response in PEF varies with the degree of baseline airflow obstruction; however, the degree of airflow obstruction has no effect on the time to best observed response.

Research paper thumbnail of Efficacy and Safety of Fluticasone Propionate/Salmeterol HFA 134A MDI in Patients with Mild‐to‐Moderate Persistent Asthma

The objective of this study was to compare the efficacy and safety of fluticasone propionate (FP)... more The objective of this study was to compare the efficacy and safety of fluticasone propionate (FP) (44 microg)/salmeterol (21 microg) delivered as two inhalations twice daily via a single hydrofluoroalkane (HFA 134a) metered dose inhaler (MDI) (FSC) with that of placebo HFA 134a (PLA), fluticasone propionate 44 microg chlorofluorocarbon (CFC) alone and salmeterol 21 microg CFC alone (S) in patients (n=360) with persistent asthma previously treated with beta2-agonists (short- or long-acting) or inhaled corticosteroids (ICS). After 12 weeks of treatment, patients treated with FSC had a significantly greater increase (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; or = 0.006) in mean FEV1 AUC(bl) compared with PLA, FP, or S. At end point, mean change from baseline in morning predose FEV1 for FSC (0.58 L) was significantly (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; or = 0.004) greater than PLA (0.14 L), FP (0.36 L), and S (0.25 L). Patients treated with FSC also had a significantly higher probability of remaining in the study without being withdrawn due to worsening asthma (2%) compared with those in the PLA (29%) and S (25%) groups (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 0.001). Finally, treatment with FSC resulted in significantly (p &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; or = 0.007) greater improvements in morning and evening peak expiratory flow, need for rescue albuterol, and asthma symptom scores compared with FP, S, and PLA. The safety profile of FSC was also similar to FP or S alone. Initial maintenance treatment of the two main components of asthma, inflammation, and smooth muscle dysfunction (e.g., bronchoconstriction), with FSC results in greater overall improvements in asthma control compared with treatment of either individual component alone.

Research paper thumbnail of Short-term and long-term asthma control in patients with mild persistent asthma receiving montelukast or fluticasone: A randomized controlled trial

Data Revues 00916749 V115i2ss S0091674904038692, Aug 18, 2011

To determine whether montelukast is as effective as fluticasone in controlling mild persistent as... more To determine whether montelukast is as effective as fluticasone in controlling mild persistent asthma as determined by rescue-free days. SUBJECTS AND METHODS: Participants aged 15 to 85 years with mild persistent asthma (n ϭ 400) were randomized to oral montelukast (10 mg once nightly) or inhaled fluticasone (88 g twice daily) in a year-long, parallel-group, multicenter study with a 12-week, double-blind period, followed by a 36-week, open-label period.

Research paper thumbnail of Corticosteroids in the Treatment of Allergic Rhinitis

Immunology and Allergy Clinics of North America, Jan 11, 1999

Research paper thumbnail of Fluticasone propionate/formoterol fumarate combination therapy has superior efficacy to both fluticasone and formoterol alone

European Respiratory Journal, Sep 1, 2011

Research paper thumbnail of More Concerning Asthma and Exercise

Research paper thumbnail of Long-acting β2-agonist salmeterol compared with albuterol in maintenance asthma therapy

Annals of Allergy Asthma Immunology, 1995

Research paper thumbnail of Effect of Mometasone Furoate/Formoterol (MF/F) Combination Therapy on Nocturnal Awakenings in Subjects With Persistent Asthma

J Allerg Clin Immunol, 2010

Research paper thumbnail of Formoterol Delivered via a Dry Powder Inhaler (Aerolizer*): Results from Long-term Clinical Trials in Children

Current Medical Research and Opinion, Feb 1, 2002

Over 500 children with asthma, aged 5-12 years, have been treated with formoterol fumarate (Forad... more Over 500 children with asthma, aged 5-12 years, have been treated with formoterol fumarate (Foradil) delivered via the Aerolizer dry powder inhaler in clinical trials, with treatment periods of up to 15 months. In pivotal double-blind trials, two dose levels, 12 and 24 microg taken twice daily, provided significant benefit in terms of lung function measurements and symptom control (a lower dose of 6 microg twice daily appeared insufficient with this formulation). The higher, 24 microg dose appeared to provide an additional margin of benefit in a subgroup of children with more unstable/severe disease when the results from long-term follow-up (12-15 months) were analysed. Formoterol was shown to have a good safety profile when taken as regular maintenance treatment and when used as rescue medication by patients already receiving formoterol as regular maintenance treatment. In this flexible regimen, with formoterol used for rescue and maintenance, the overall daily intake of formoterol was low, with 96.1% of all treatment days (n = 2452) covered by a total daily dose (regular + rescue) of 48 microg (four doses) or less. There was no increase in the average daily intake of rescue formoterol over time. The clinical efficacy associated with this regimen was maintained over time and, in the case of morning peak expiratory flow rate, steadily improved over time. The Foradil Aerolizer inhalation system is simple to use and has a low resistance to inspiratory airflow that maximises the patient&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;#39;s control over dosing, while minimising the risk of under- and overdosing. These features may be especially valuable in a young patient population.

Research paper thumbnail of Efficacy and safety of budesonide administered by pressurized metered-dose inhaler in children with asthma

Annals of Allergy, Asthma & Immunology, 2015

Budesonide is approved for delivery using a nebulized solution and dry-powder inhaler, but its us... more Budesonide is approved for delivery using a nebulized solution and dry-powder inhaler, but its use through a pressurized metered-dose inhaler (pMDI) in pediatric patients with asthma has not been determined. To examine the efficacy and safety of 160 μg twice daily of budesonide through a pMDI vs placebo in children 6 to younger than 12 years with asthma and a demonstrated need for inhaled corticosteroids. A 6-week, international, multicenter, double-blinded, parallel-group, phase 2 study randomized 304 pediatric patients (mean age, 9 years; 21.7% &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt;8 years) 1:1 to 160 μg (80 μg × 2 inhalations) twice daily of budesonide through a pMDI or placebo after a 7- to 21-day run-in period. The primary efficacy end point was change from baseline in morning peak expiratory flow (PEF); safety end points included adverse events, vital signs, and discontinuations. Budesonide treatment significantly improved morning PEF vs placebo; mean treatment effect (budesonide vs placebo) was 13.6 L/min (P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .0001). Budesonide also showed significant improvements vs placebo for forced expiratory volume in 1 second, evening PEF, forced expiratory flow at 25% to 75% of pulmonary volume, reliever medication use, nighttime awakenings, awakenings with reliever use, and percentage of patients with at least 15- and at least 30-L/min increase in morning PEF from baseline. The numbers of patients experiencing adverse events and discontinuations were smaller in the budesonide than in the placebo group. No serious adverse events were reported. Budesonide at 160 μg twice daily through a pMDI was generally well tolerated and significantly improved lung function, symptoms, rescue medication use, and nighttime awakenings vs placebo in children 6 to younger than 12 years with asthma and a demonstrated need for inhaled corticosteroids.