A twelve-week comparison of salmeterol and salbutamol in the treatment of mild-to-moderate asthma: A Canadian multicenter study (original) (raw)
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A 1-week dose-ranging study of inhaled salmeterol in patients with asthma
CHEST Journal, 1994
A dose-ranging study was conducted to evaluate the efficacy and safety of a new long-acting, selective fl2-adrenoceptor agonist, salmeterol. De8ign: Adolescents and adults (N160) with mildto-moderate asthma received salmeterol (10.5, 21, 42, or 84 Mg) or placebo by metered-dose inhaler twice daily for 1 week. Twelve-hour serial spirometry measurements were performed on the first and last days of treatment, and patients recorded their peak expiratory flow (PEF) twice daily on diary cards. Results: On day 1, salmeterol produced greater bronchodilation than placebo (pO.OO1), and both the 42-Mg and 84-Mg doses 5From the Intermountain Allergy and Asthma Clinic,
Chest, 2000
Study objectives: To assess the safety and efficacy of salmeterol xinafoate as an adjunct to conventional therapy for the in-hospital management of acute asthma. Design: A prospective, double-blind, randomized placebo-controlled trial. Setting: Medical wards of a large university-based hospital. Patients: Forty-three patients admitted for an acute exacerbation of asthma. Interventions: Salmeterol (42 g) or two puffs of placebo every 12 h in addition to standard therapy (short-acting -agonists, corticosteroids, and anticholinergic agents). Results: No clinically adverse effects were seen with the addition of salmeterol to conventional therapy. After salmeterol, there was no difference in pulse, respiratory rate, oxygen saturation by pulse oximetry, severity of symptoms, or dyspnea score. Patients receiving salmeterol had greater FEV 1 percent improvements than the placebo group at 12, 24, 36, and 48 h. These findings were not statistically significant. By paired Student's t tests, there were significant improvements in FEV 1 (p ؍ 0.03) and FVC (p ؍ 0.03) in the salmeterol group after 48 h of treatment with no comparable improvement in the placebo group. In a subgroup analysis of patients with an initial FEV 1 < 1.5 L, the absolute FEV 1 percent improvement for salmeterol vs placebo was 51% vs 16% at 24 h and 54% vs 40% at 48 h. The relative FEV 1 percent improvement for salmeterol vs placebo was 17% vs 8% at 24 h and 18% vs 14% at 48 h. Conclusion: The addition of salmeterol to conventional therapy is safe and may benefit hospitalized patients with asthma. Further studies are needed to clarify its role in the treatment of acute exacerbation of asthma.
Canadian Respiratory Journal, 1997
STUDY OBJECTIVE: To compare two dosing regimens of salbutamol in acute asthma.DESIGN: Prospective randomized double-blind trial.SETTING: Urban emergency department.TYPE OF PARTICIPANTS: Patients who presented to the emergency department with moderate to severe asthma.INTERVENTIONS: All patients had pulmonary function testing and were randomized to group A (control; n=25) or group B (experimental; n=23). Group A (control) patients received salbutamol 2.5 mg delivered by wet aerosol at 0, 1 and 2 h (total dose 7.5 mg). At 20, 40, 80 and 100 mins a placebo aerosol was given. Group B patients received salbutamol 5 mg at 0 min and one-third the initial dose every 20 mins for a total of six doses by wet aerosol (total dose 15 mg).RESULTS: There were no differences in age, sex, preadmission medications or initial forced expiratory volume in 1 s (FEV1) between the groups. Forty-eight patients completed the study. Both groups of patients improved with mean absolute change in FEV1of 700 mL in...
A comparison of regular salmeterol vs ‘as required’ salbutamol therapy in asthmatic children
Respiratory Medicine, 1998
TGlaxo Wellcome on behalf of an Infernafional Study Group In a multicentre, double-blind, randomized, parallel study, 426 asthmatic children aged 5-15 years old received salmeterol 50,~g b.i.d. or placebo b.i.d. via the Diskhaler@. All patients had access to inhaled salbutamol to be used on an 'as required' (p.r.n.) basis for symptomatic relief. The study design comprised a 2-week baseline, a 1Zmonth treatment period incorporating a 2-week 'off treatment' after 6 months, and a 2-week follow-up period at the end of the trial. At the end of 12 months of treatment with salmeterol, the adjusted change from baseline for morning and evening peak expiratory flow rate (PEF) was 56 and 47 1 min ~ ', respectively, and this was significantly greater than placebo (PcO.01; WO.05). Exacerbation rates did not differ between groups and results were not dependent upon concurrent inhaled steroid use. Neither treatment caused a change of z 1 doubling dose in PC,,/PD,, either during or on stopping treatment. Treatment with regular salmeterol 5Opg b.i.d. over a 12-month treatment period provides a significant, rapid and well-maintained improvement in lung function without increasing bronchial reactivity or asthma exacerbation rates compared to p.r.n. salbutamol.
European Journal of Clinical Pharmacology, 1999
In this double-blind, placebo-controlled, crossover study we compared the bronchoprotective effects of formoterol 12 g inhaled via an HFA-134a inhaler (Modulite ® HFA) versus a CFC and a DPI device in 38 patients with mildto-moderate persistent asthma. All three formoterol preparations signifi cantly increased methacholine PD 20 and FEV 1 and improved small airway function parameters compared with placebo (p ! 0.001). No signifi cant differences were observed between formoterol formulations. In conclusion, Modulite ® HFA formoterol was found to be an effective and well tolerated treatment in patients with asthma, with comparable effi cacy to current formoterol preparations.
Annals of Allergy, Asthma & Immunology, 1999
Background: There is a paucity of data comparing the long-term safety and efficacy of long-acting inhaled beta 2-agonists versus low-dose inhaled corticosteroids in the treatment of asthma. Objective: To compare the safety and efficacy of salmeterol xinafoate, beclomethasone dipropionate (BDP), and placebo over a 6-month treatment period in patients with persistent asthma. Methods: Salmeterol (42 g twice daily), BDP (84 g four times daily), or placebo was administered via metered-dose inhaler to 386 adolescent and adult inhaled corticosteroid-naive patients in a randomized, double-blind, double-dummy, parallel-group study. Eligible patients demonstrated a forced expiratory volume in 1 second (FEV 1) from 65% to 90% of predicted values. Pulmonary function, symptom control, frequency of asthma exacerbations, bronchial hyperresponsiveness (BHR) to methacholine challenge, and adverse events were assessed. Results: There were few statistically significant differences between the two active treatments over 6 months of therapy. Asthma symptoms and lung function were significantly improved with both salmeterol and BDP compared with placebo (changes from baseline in FEV 1 of 0.28 L (SE ϭ 0.04) and 0.23 L (SE ϭ 0.04), respectively, compared with 0.08 L (SE ϭ 0.04); P Յ .014). There were no significant differences among the treatment groups with respect to the distribution of asthma exacerbations over time. Both salmeterol and BDP significantly reduced BHR compared with placebo (P Յ .033; changes from baseline of 1.29 (SE ϭ 0.26) and 1.42 (SE ϭ 0.24) doubling doses at 6 months, respectively, compared with 0.24 (SE ϭ 0.29) doubling dose for placebo). No rebound effect in BHR was seen upon cessation of any of the three treatment regimens. There were no clinically important differences in the safety profiles among the three treatments. Conclusions: Both salmeterol and BDP are effective and well-tolerated when administered for 6 months to inhaled corticosteroid-naive patients with persistent asthma.
BMJ, 1997
Objective: To determine trends in asthma mortality by age group in England and Wales during 1983-95. Design: Observational study. Setting: England and Wales. Subjects: All deaths classified as having an underlying cause of asthma registered from 1 January 1983 to 31 December 1995. Main outcome measure: Time trends for age specific asthma deaths. Results: Deaths in the age group 5-14 years showed an irregular downward trend during 1983-95; deaths in the age groups 15-44, 45-64, and 65-74 years peaked before 1989 and then showed a downward trend; and deaths in the age group 75-84 years peaked between 1988 and 1993 and subsequently dropped. Trends were: age group 5-14 years, 6% (95% confidence interval 3% to 9%); 15-44 years, 6% (5% to 7%); 45-64 years, 5% (4% to 6%); 65-74 years, 2% (1% to 3%). Deaths in the 75-84 and 85 and over categories plateaued. Conclusions: There are downward trends in asthma mortality in Britain, which may be due to increased use of prophylactic treatment.
Aim: To evaluate the role of salmeterol in adjuvant therapy with inhaled corticosteroids in patients with mild to moderate asthma. Study design: A Randomized clinical trial Place and duration of studies: The study was conducted at the Medicine Unit-II of Sir Gang ram Hospital Lahore for one-year duration from August 2019 to August 2020. Methodology: Fifty patients with mild to moderate asthma aged 15-65 years were divided into two groups. Patients in the study group received a combination of salmeterol 50 µg and fluticasone propionate 250 µg twice daily, patients in the control group received beclomethasone dipropionate 500 µg twice daily. The endpoints were reduction in Symptom Score and improvement in maximum expiratory flow (PEFR) checked every two weeks. The paired student test was used to analyze the data. Results: In patients in the study group, the mean total symptom score decreased significantly from 11.16 from baseline to 0.41 (p <0.001) at the end of the study, and the mean PEFR increased significantly from 189.4 L / min ± 0. 34 to 354.58 l / min, 0.15; P-value <0.001. While in the control group, the reduction in the mean total symptom score and the increase in mean PEFR was negligible, i.e. Total symptom score 11.04 from baseline to 5.29 and mean PEFR reduced from 182.60 L / min ± 17, 05 to 231.73L / min ± 13.84. Conclusion: Salmeterol plays a significant role in the treatment of mild to moderate patients with asthma.
National Journal of Medical Research, 2013
Introduction: The World Health Organization has estimated that 15 million disability-adjusted life years (DALYs) are lost annually due to asthma, representing 1% of the total global disease burden. Racemic Salbutamol and Levo Salbutamol both have potent broncho-dilatory effect and therefore, both are used in the treatment of Asthma. The study was conducted to compare bronchodilatory efficacy potential of Salbutamol with Levo-Salbutamol. Methodology: The present study was conducted among 100 patients at a tertiary care hospital mild to moderate persistent asthma. Patients were divided in two groups, 50 subjects in each group. After performing baseline spirometry, group A and group B subjects were given 2.5 mg salbutamol and 1.25 mg levosalbutamol, respectively, through nebulizer (continuous, compressor type of nebulizer with drug particle size 0.5-5 micron and average nebulization rate 0.2ml/min.). After 20 minutes, repeat spirometry was performed to measure bronchodilatory response. Results: Two groups are comparable for base line characteristics, as there is no age & sex wise and symptom wise significant difference in the distribution of patients (p >0.05 for all variables). Overall picture is suggestive of no significant statistical difference in bronchodilatory potential between Salbutamol and Levo-Salbutamol. Positive raise in FEV1, FEV1/FVC% and PEFR is statistically not significant in both groups (P>0.05 for all three). Conclusion: Salbutamol and Levo-Salbutamol had isoeffective bronchodilatory potential in bronchial asthma patients when used at equipotent doses.
Respiratory Medicine, 2001
This multi-centre, randomized, double-blind, double-dummy, parallel-group study was designed to investigate the hypothesis of equivalent efficacy and comparable safety of two inhaled presentations of salmeterol/fluticasone propionate combination product (SALM/FP) 50/100 mg administered twice daily to patients with mild-to-moderate asthma for 12 weeks. The delivery systems were a 25/50 mg strength hydrofluoroalkane (HFA) metered-dose inhaler (MDI) and a Diskus TM inhaler (50/100 mg strength). A third group received FP 100 mg twice daily via a chlorofluorocarbon MDI (50 mg strength). A total of 497 patients aged 11-79 years with reversible airways obstruction who were symptomatic on inhaled corticosteroid (ICS) therapy and had room for improvement in lung function were randomized to treatment in a double-blind, parallel-group design (SALM/FP MDI: n¼165; SALM/ FP Diskus TM : n¼167; FP MDI: n¼165) for 12 weeks. A total of 383 patients completed the study according to the protocol.