Gilbert Shanga - Academia.edu (original) (raw)

Papers by Gilbert Shanga

Research paper thumbnail of Magnetic resonance imaging reveals the complementary effects of decongestant and Breathe Right Nasal Strips on internal nasal anatomy

Laryngoscope, Feb 10, 2016

This magnetic resonance imaging (MRI) study of 26 subjects with nasal congestion was performed to... more This magnetic resonance imaging (MRI) study of 26 subjects with nasal congestion was performed to assess in the complete nasal passage both the anatomical effect of the marketed Breathe Right Nasal Strip (BRNS) relative to placebo and the potential adjunctive effect of using a decongestant in combination with the BRNS. Randomized, crossover study. The study consisted of two parts, the first involving application of either the BRNS or the placebo strip in a randomized, crossover design with evaluator blinding, and repeated MRI scanning; and the second a sequential process of decongestant administration, MRI scanning, application of the BRNS, and repeated MRI. The same anatomical MRI protocol was used throughout. Nasal patency was assessed in the whole nasal passage and eight subregions (by inferior-superior, anterior-posterior division). Numerical response scores representing subjective nasal congestion were also obtained. Results demonstrate significant anatomical enlargement with the BRNS relative to placebo (P < .001), as well as an additive effect of using a decongestant in combination with the BRNS; both supported by a strong and significant negative correlation with the subjective nasal response measures of nasal congestion (r = -0.98, P = .002). Furthermore, analysis of the nasal subregions indicates that this adjunctive effect arises from a partially localized action of the complementary products: the BRNS acting primarily anteriorly in the nose and the decongestant mainly posteriorly. The BRNS alone significantly increases nasal patency and alleviates perceived nasal congestion, and additional relief of symptoms can be obtained with simultaneous use of a decongestant. 1b. Laryngoscope, 2016.

Research paper thumbnail of Nicotine Lozenges in the Relief of Behaviorally Provoked Craving

American Journal of Health Behavior, May 1, 2018

Objectives: Environmental cues may precipitate nicotine cravings in smokers. We present 2 studies... more Objectives: Environmental cues may precipitate nicotine cravings in smokers. We present 2 studies exploring the efficacy of nicotine mini lozenges to reduce nicotine craving in smokers following behavioral provocation. Methods: Healthy smokers aged ≥18 years enrolled. In Study 1, participants were stratified by number of cigarettes smoked daily; Study 2 enrolled only heavy smokers. After an abstinence period, participants engaged in behavioral provocation to induce nicotine craving before receiving a nicotine mini lozenge (Study 1: 1.5 mg or 4 mg; Study 2: 4 mg) or matching placebo. Craving was assessed using a 100-mm visual analogue scale, and safety was monitored. Results: In Study 1, neither nicotine mini lozenge dose significantly reduced craving in smokers versus placebo. In Study 2, 4-mg nicotine mini lozenges significantly reduced craving scores 5 minutes post-treatment (least-square mean [LSM] change from baseline: −41.8; 95% confidence interval [CI]: −45.8, −37.7) versus placebo (−25.9; 95% CI: −30.0, −21.8; p < .001). Adverse events were infrequent, mild in intensity, and more common with the 4-mg nicotine mini lozenges. Conclusions: Behaviorally provoked nicotine craving can be significantly and safely reduced in heavy/high-dependency smokers with 4-mg nicotine mini lozenges.

Research paper thumbnail of Randomized Trials of Nasal Patency and Dermal Tolerability With External Nasal Dilators in Healthy Volunteers

Allergy & rhinology, 2018

Background: External nasal dilator strips are used as nonpharmacological therapy to reduce snorin... more Background: External nasal dilator strips are used as nonpharmacological therapy to reduce snoring and daytime sleepiness. In a product improvement initiative, a marketed strip (BRNS) and 2 prototype nasal strips were evaluated. Objective: To compare the nasal patency and multiple-use dermal tolerability of the BRNS and prototype nasal strips using both objective and subject-reported outcome measures. Methods: Two studies were conducted separately in healthy volunteers !18 years of age. A single-day nasal patency randomized crossover study assessed minimal cross-sectional area (MCA; second restriction) and nasal volume (using acoustic rhinometry); nasal inspiratory flow and resistance (using posterior rhinomanometry); and subject-reported evaluations of the BRNS compared with the butterfly strip and teardrop strip prototypes. A single-center, randomized, controlled, parallel-group, evaluator-blinded study assessed dermal tolerability of the BRNS and the butterfly strip over 7 consecutive nights of use, using the Dermal Response Scale (DRS) and subject-reported comfort and ease of removal. Results: In the Patency study (N ¼ 50), all 3 strips demonstrated significant improvement from baseline in MCA, nasal volume, and nasal flow parameters (resistance and peak flow). The prototype strips demonstrated significantly more improvement in nasal volume than the BRNS, and the butterfly strip showed significantly more improvement in MCA than the BRNS; all strips were similar with respect to nasal flow and subject-reported nasal breathing outcomes. In the Dermal Tolerability study (N ¼ 82), all subjects scored 0 (no evidence of irritation) on the DRS at all 7 morning assessments; the BRNS was numerically, but not significantly, superior to the butterfly strip on subject-reported outcomes. Conclusion: The Patency study demonstrated significant improvement from baseline in nasal dimensions and flow for all 3 evaluated strips; between-strip differences were confined to nasal dimensions. Both the BRNS and butterfly strip were generally well tolerated, with no evidence of dermal response over 7 consecutive nights of use.

Research paper thumbnail of Correction to: Objective and Subjective Effects of a Prototype Nasal Dilator Strip on Sleep in Subjects with Chronic Nocturnal Nasal Congestion

Advances in Therapy, Sep 4, 2019

Research paper thumbnail of Objective and Subjective Effects of a Prototype Nasal Dilator Strip on Sleep in Subjects with Chronic Nocturnal Nasal Congestion

Advances in Therapy, May 22, 2019

Introduction: This exploratory study characterized the performance of a nasal dilator strip with ... more Introduction: This exploratory study characterized the performance of a nasal dilator strip with improved spring forces in lowering nasal resistance during sleep and reducing sleep-disordered breathing in subjects with difficulty sleeping due to chronic nocturnal nasal congestion. Methods: Subjects applied the strip at bedtime for 28 days (active phase; n = 70). Objective assessments included snoring variables, breathing route during sleep, and polysomnography measures compared with baseline. Nasal breathing, congestion, and sleep were measured subjectively using rating scales and questionnaires. During a crossover nasal resistance phase (n = 55), nasal resistance was measured using posterior rhinomanometry with the strip applied on one of two nights. Results: In the active phase, breathing and sleep were perceived to improve, with less daytime sleepiness (P \ 0.04) and increased ease of breathing, sleep quality, staying asleep, and feeling refreshed in the morning (all P\ 0.0001). However, while objective polysomnography metrics were generally similar with and without the strip, median wake after sleep onset time was numerically reduced by * 11 min, and the spontaneous arousal rate fell by * 37%. In the nasal resistance phase (n = 55), median resistance (at 0.2-0.25 l/s) while asleep was 39.1% lower with (n = 37) versus without (n = 36) the strip (1.34 vs. 2.20 cmH 2 O/l/s; P = 0.048). Conclusions: This exploratory study supports a role for the improved spring force nasal dilator strip in alleviating sleep-related symptoms in subjects with chronic nasal congestion, potentially via lowering nasal resistance and reducing nocturnal awakenings. A larger study is indicated to confirm these preliminary data. ClinicalTrials.gov identifier: NCT03105297.

Research paper thumbnail of Correction to: Sleep Quality and Congestion with Breathe Right Nasal Strips: Two Randomized Controlled Trials

Advances in Therapy, Sep 4, 2019

Research paper thumbnail of Effects of nasal dilator strips on subjective measures of sleep in subjects with chronic nocturnal nasal congestion: a randomized, placebo-controlled trial

Allergy, Asthma & Clinical Immunology, Aug 27, 2018

Background: This exploratory study investigated effects of a new asymmetric butterfly-shaped prot... more Background: This exploratory study investigated effects of a new asymmetric butterfly-shaped prototype nasal dilator strip and the currently marketed clear Breathe Right Nasal Strip (BRNS) on subjective measures of nasal congestion and sleep quality. Methods: In this randomized, double-blind study, subjects with chronic nasal congestion and sleep difficulties were assigned a BRNS clear strip, an asymmetric butterfly prototype, or an asymmetric butterfly placebo strip without springs, to use nightly for 2 weeks. The main outcomes included change from baseline to days 7 and 14 on the Pittsburgh Insomnia Rating Scale (PIRS), Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ), and Congestion Quantifier Seven-Item Test (CQ7). Results: The intent-to-treat population included 59 subjects. The butterfly and BRNS strips showed significant (P < 0.05) improvement versus placebo on PIRS satisfaction with sleep at day 7 [least square (LS) mean changes: − 0.7, − 0.6, and − 0.2, respectively], and the butterfly strip also showed significant improvement from baseline on this outcome versus placebo at day 14 (− 1.0 vs − 0.5). On the NRQLQ, both the butterfly prototype and BRNS clear were more effective than placebo in improving symptoms on waking at day 7 (LS mean changes: − 7.9, − 7.2, and − 4.1, respectively); the BRNS clear was significantly more effective than placebo in improving sleep problems at day 7 (− 7.4 vs − 4.2). There were no between-treatment differences on the CQ7. All strips were well tolerated. Conclusions: The asymmetric butterfly prototype and BRNS clear strip significantly improved some subjective measures of nasal congestion and sleep compared with placebo in subjects with nasal congestion and sleep difficulties. Trial registration This study is registered at ClinicalTrials.gov (identifier: NCT01122849

Research paper thumbnail of Removal of oral debris and bacteria during supervised tooth brushing

Archives of Oral Biology, Apr 1, 2008

Objective: To investigate foam generation during brushing, and the oral debris and bacteria remov... more Objective: To investigate foam generation during brushing, and the oral debris and bacteria removal efficacy of an experimental gel-to-foam dentifrice compared to a commercially-available dentifrice after brushing. Methods: Thirty-four subjects participated in this blinded, crossover study. After a wash-out period prior to each session of product use, subjects reported to the site having abstained from oral hygiene, eating and drinking from 22:00 h on the evening prior to treatment visits. The subjects brushed with a weighed dose of assigned paste and were asked to expectorate their toothpaste slurry into a collection vessel at 30 and 60 seconds during supervised brushing. The expectorated foam was measured immediately, after which subjects rinsed with 10 ml of sterile water and expectorated into the same vessel. Samples were placed on ice and immediately transported to the laboratory for analysis. Bacteria (total anaerobes and VSC-producing bacteria) were enumerated using appropriate selective media. To calculate the amount of debris, a measured portion of the sample was deposited onto a pre-weighed dish and weighed. Dishes were dried thoroughly and weighed again after cooling. Results: Use of the gel-to-foam dentifrice resulted in 105% greater foam volume compared with use of the control dentifrice (p < 0.0001). Further, the gel-to-foam dentifrice removed 15.77% more debris than the control dentifrice (p-value = 0.0342). There was greater removal of total anaerobes and VSC-producing bacteria by the gel-to-foam dentifrice versus the control dentifrice (p-value < 0.0001). Conclusion: Single use of a gel-to-foam dentifrice generated a greater volume of foam and removed a greater amount of oral debris and bacteria during brushing than a standard dentifrice.

Research paper thumbnail of Single-Dose Bioequivalence of Two Mini Nicotine Lozenge Formulations

Clinical pharmacology in drug development, Nov 28, 2017

Diverse nicotine replacement therapy options may improve consumer usage. This study was conducted... more Diverse nicotine replacement therapy options may improve consumer usage. This study was conducted to establish the bioequivalence of a new cherry-flavored mini lozenge with that of a currently marketed mint-flavored mini lozenge. The rate (C max) and extent (AUC 0-t) of plasma nicotine absorption were compared after administration of 2-and 4-mg doses of each lozenge in healthy adult smokers (n = 43). The bioequivalence of each respective dose was established based on the 90% confidence interval for the ratio of geometric means for both C max and AUC 0-t lying within the range of 0.80 to 1.25. Adverse-event profiles were similar between formulations.

Research paper thumbnail of Patients’ experience and utilization patterns of diclofenac gel in Germany: a real-world study with a prospective longitudinal survey and a retrospective analysis of pharmacy data

Current Medical Research and Opinion

Research paper thumbnail of MOESM4 of Effects of nasal dilator strips on subjective measures of sleep in subjects with chronic nocturnal nasal congestion: a randomized, placebo-controlled trial

Additional file 4: Table S4. Subject diary ratings of breathing before and after strip removal up... more Additional file 4: Table S4. Subject diary ratings of breathing before and after strip removal upon awakening (ITT population).

Research paper thumbnail of MOESM3 of Effects of nasal dilator strips on subjective measures of sleep in subjects with chronic nocturnal nasal congestion: a randomized, placebo-controlled trial

Additional file 3: Table S3. Subject diary ratings of nasal stuffiness before and after strip rem... more Additional file 3: Table S3. Subject diary ratings of nasal stuffiness before and after strip removal upon awakening (ITT population).

Research paper thumbnail of MOESM2 of Effects of nasal dilator strips on subjective measures of sleep in subjects with chronic nocturnal nasal congestion: a randomized, placebo-controlled trial

Additional file 2: Table S2. Subjects showing any improvement on the daily diary questions after ... more Additional file 2: Table S2. Subjects showing any improvement on the daily diary questions after strip application on night 1.

Research paper thumbnail of MOESM1 of Effects of nasal dilator strips on subjective measures of sleep in subjects with chronic nocturnal nasal congestion: a randomized, placebo-controlled trial

Additional file 1: Table S1. Composite PIRS measures in subgroup of subjects at risk for sleep ap... more Additional file 1: Table S1. Composite PIRS measures in subgroup of subjects at risk for sleep apnea (ITT population).

Research paper thumbnail of Evaluating the Moisturizing Abilities and Sun Protection Factor of New Lip Balm Formulations

Journal of cosmetic science, 2019

This report explores dry-skin models to assess the potential of a new lip balm formulation to hyd... more This report explores dry-skin models to assess the potential of a new lip balm formulation to hydrate dry skin or lips, and presents sun protection factor (SPF) values for five new lip balm formulations. Evaporimeter [for transepidermal water loss (TEWL)], Skicon®, and Corneometer® were used to measure hydrating effects of lip balm formulations in a dry-skin leg model, and TEWL, DermaLab® Moisture Meter, Corneometer®, and visual assessments were used with a dry-lip model. SPF studies were conducted in accordance with either the U.S. Food and Drug Administration monograph final rule or international standard ISO 24444. Data from dry-skin leg model demonstrate that a new lip balm formulation significantly improves skin hydration compared with untreated leg skin and four comparator products. Data obtained from a dry-lip model proved unreliable. Five new lip balm formulations exhibited sunscreen capability; however, they did not meet the intended SPF. There were no product-related adver...

Research paper thumbnail of A series of in vitro and human studies of a novel lip cream formulation for protecting against environmental triggers of recurrent herpes labialis

Clinical, Cosmetic and Investigational Dermatology, 2019

Purpose: These studies describe the testing of a novel, daily-use lip cream designed for individu... more Purpose: These studies describe the testing of a novel, daily-use lip cream designed for individuals with lips prone to recurrent herpes labialis (RHL) that protects against environmental triggers. Subjects and methods: In vitro occlusive and in vitro and in vivo photoprotection analyses, a characterization of normal vs dry lips, and a randomized, evaluator-blinded, clinical trial that assessed the lip cream in healthy subjects with dry lips were conducted. In the clinical trial, subjects applied the lip cream or were untreated and evaluated using transepidermal water loss (TEWL), corneometry, visual assessments of lip dryness, expert photographic evaluations, and subject-rated outcomes. Results: The lip cream's in vitro water vapor transmission rate (84.1 g/(m 2 h)) indicated moderate occlusivity. The lip cream, but not placebo or control (water), reduced ultraviolet A (UVA)-and UVB-induced DNA damage, and tumor necrosis factor-α (EpiDerm FT) and prostaglandin E 2 release (EpiDerm FT and EpiGingival™). The lip cream's in vivo sun protection factor (SPF) was 12.2 (lower confidence limit, 11.3) and SPF/UVA protection factor ratio was 0.9. The characterization of dry vs normal lips identified differences in moisturization. In the clinical trial, the lip cream significantly decreased TEWL (

Research paper thumbnail of Nicotine Lozenges in the Relief of Behaviorally Provoked Craving

American Journal of Health Behavior, 2018

Objectives: Environmental cues may precipitate nicotine cravings in smokers. We present 2 studies... more Objectives: Environmental cues may precipitate nicotine cravings in smokers. We present 2 studies exploring the efficacy of nicotine mini lozenges to reduce nicotine craving in smokers following behavioral provocation. Methods: Healthy smokers aged ≥18 years enrolled. In Study 1, participants were stratified by number of cigarettes smoked daily; Study 2 enrolled only heavy smokers. After an abstinence period, participants engaged in behavioral provocation to induce nicotine craving before receiving a nicotine mini lozenge (Study 1: 1.5 mg or 4 mg; Study 2: 4 mg) or matching placebo. Craving was assessed using a 100-mm visual analogue scale, and safety was monitored. Results: In Study 1, neither nicotine mini lozenge dose significantly reduced craving in smokers versus placebo. In Study 2, 4-mg nicotine mini lozenges significantly reduced craving scores 5 minutes post-treatment (least-square mean [LSM] change from baseline: −41.8; 95% confidence interval [CI]: −45.8, −37.7) versus placebo (−25.9; 95% CI: −30.0, −21.8; p < .001). Adverse events were infrequent, mild in intensity, and more common with the 4-mg nicotine mini lozenges. Conclusions: Behaviorally provoked nicotine craving can be significantly and safely reduced in heavy/high-dependency smokers with 4-mg nicotine mini lozenges.

Research paper thumbnail of Randomized Trials of Nasal Patency and Dermal Tolerability With External Nasal Dilators in Healthy Volunteers

Allergy & Rhinology, 2018

Background External nasal dilator strips are used as nonpharmacological therapy to reduce snoring... more Background External nasal dilator strips are used as nonpharmacological therapy to reduce snoring and daytime sleepiness. In a product improvement initiative, a marketed strip (BRNS) and 2 prototype nasal strips were evaluated. Objective To compare the nasal patency and multiple-use dermal tolerability of the BRNS and prototype nasal strips using both objective and subject-reported outcome measures. Methods Two studies were conducted separately in healthy volunteers ≥18 years of age. A single-day nasal patency randomized crossover study assessed minimal cross-sectional area (MCA; second restriction) and nasal volume (using acoustic rhinometry); nasal inspiratory flow and resistance (using posterior rhinomanometry); and subject-reported evaluations of the BRNS compared with the butterfly strip and teardrop strip prototypes. A single-center, randomized, controlled, parallel-group, evaluator-blinded study assessed dermal tolerability of the BRNS and the butterfly strip over 7 consecuti...

Research paper thumbnail of Correction to: Sleep Quality and Congestion with Breathe Right Nasal Strips: Two Randomized Controlled Trials

Advances in Therapy, 2019

Research paper thumbnail of Correction to: Objective and Subjective Effects of a Prototype Nasal Dilator Strip on Sleep in Subjects with Chronic Nocturnal Nasal Congestion

Advances in Therapy, 2019

Research paper thumbnail of Magnetic resonance imaging reveals the complementary effects of decongestant and Breathe Right Nasal Strips on internal nasal anatomy

Laryngoscope, Feb 10, 2016

This magnetic resonance imaging (MRI) study of 26 subjects with nasal congestion was performed to... more This magnetic resonance imaging (MRI) study of 26 subjects with nasal congestion was performed to assess in the complete nasal passage both the anatomical effect of the marketed Breathe Right Nasal Strip (BRNS) relative to placebo and the potential adjunctive effect of using a decongestant in combination with the BRNS. Randomized, crossover study. The study consisted of two parts, the first involving application of either the BRNS or the placebo strip in a randomized, crossover design with evaluator blinding, and repeated MRI scanning; and the second a sequential process of decongestant administration, MRI scanning, application of the BRNS, and repeated MRI. The same anatomical MRI protocol was used throughout. Nasal patency was assessed in the whole nasal passage and eight subregions (by inferior-superior, anterior-posterior division). Numerical response scores representing subjective nasal congestion were also obtained. Results demonstrate significant anatomical enlargement with the BRNS relative to 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;amp;amp;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; .001), as well as an additive effect of using a decongestant in combination with the BRNS; both supported by a strong and significant negative correlation with the subjective nasal response measures of nasal congestion (r = -0.98, P = .002). Furthermore, analysis of the nasal subregions indicates that this adjunctive effect arises from a partially localized action of the complementary products: the BRNS acting primarily anteriorly in the nose and the decongestant mainly posteriorly. The BRNS alone significantly increases nasal patency and alleviates perceived nasal congestion, and additional relief of symptoms can be obtained with simultaneous use of a decongestant. 1b. Laryngoscope, 2016.

Research paper thumbnail of Nicotine Lozenges in the Relief of Behaviorally Provoked Craving

American Journal of Health Behavior, May 1, 2018

Objectives: Environmental cues may precipitate nicotine cravings in smokers. We present 2 studies... more Objectives: Environmental cues may precipitate nicotine cravings in smokers. We present 2 studies exploring the efficacy of nicotine mini lozenges to reduce nicotine craving in smokers following behavioral provocation. Methods: Healthy smokers aged ≥18 years enrolled. In Study 1, participants were stratified by number of cigarettes smoked daily; Study 2 enrolled only heavy smokers. After an abstinence period, participants engaged in behavioral provocation to induce nicotine craving before receiving a nicotine mini lozenge (Study 1: 1.5 mg or 4 mg; Study 2: 4 mg) or matching placebo. Craving was assessed using a 100-mm visual analogue scale, and safety was monitored. Results: In Study 1, neither nicotine mini lozenge dose significantly reduced craving in smokers versus placebo. In Study 2, 4-mg nicotine mini lozenges significantly reduced craving scores 5 minutes post-treatment (least-square mean [LSM] change from baseline: −41.8; 95% confidence interval [CI]: −45.8, −37.7) versus placebo (−25.9; 95% CI: −30.0, −21.8; p < .001). Adverse events were infrequent, mild in intensity, and more common with the 4-mg nicotine mini lozenges. Conclusions: Behaviorally provoked nicotine craving can be significantly and safely reduced in heavy/high-dependency smokers with 4-mg nicotine mini lozenges.

Research paper thumbnail of Randomized Trials of Nasal Patency and Dermal Tolerability With External Nasal Dilators in Healthy Volunteers

Allergy & rhinology, 2018

Background: External nasal dilator strips are used as nonpharmacological therapy to reduce snorin... more Background: External nasal dilator strips are used as nonpharmacological therapy to reduce snoring and daytime sleepiness. In a product improvement initiative, a marketed strip (BRNS) and 2 prototype nasal strips were evaluated. Objective: To compare the nasal patency and multiple-use dermal tolerability of the BRNS and prototype nasal strips using both objective and subject-reported outcome measures. Methods: Two studies were conducted separately in healthy volunteers !18 years of age. A single-day nasal patency randomized crossover study assessed minimal cross-sectional area (MCA; second restriction) and nasal volume (using acoustic rhinometry); nasal inspiratory flow and resistance (using posterior rhinomanometry); and subject-reported evaluations of the BRNS compared with the butterfly strip and teardrop strip prototypes. A single-center, randomized, controlled, parallel-group, evaluator-blinded study assessed dermal tolerability of the BRNS and the butterfly strip over 7 consecutive nights of use, using the Dermal Response Scale (DRS) and subject-reported comfort and ease of removal. Results: In the Patency study (N ¼ 50), all 3 strips demonstrated significant improvement from baseline in MCA, nasal volume, and nasal flow parameters (resistance and peak flow). The prototype strips demonstrated significantly more improvement in nasal volume than the BRNS, and the butterfly strip showed significantly more improvement in MCA than the BRNS; all strips were similar with respect to nasal flow and subject-reported nasal breathing outcomes. In the Dermal Tolerability study (N ¼ 82), all subjects scored 0 (no evidence of irritation) on the DRS at all 7 morning assessments; the BRNS was numerically, but not significantly, superior to the butterfly strip on subject-reported outcomes. Conclusion: The Patency study demonstrated significant improvement from baseline in nasal dimensions and flow for all 3 evaluated strips; between-strip differences were confined to nasal dimensions. Both the BRNS and butterfly strip were generally well tolerated, with no evidence of dermal response over 7 consecutive nights of use.

Research paper thumbnail of Correction to: Objective and Subjective Effects of a Prototype Nasal Dilator Strip on Sleep in Subjects with Chronic Nocturnal Nasal Congestion

Advances in Therapy, Sep 4, 2019

Research paper thumbnail of Objective and Subjective Effects of a Prototype Nasal Dilator Strip on Sleep in Subjects with Chronic Nocturnal Nasal Congestion

Advances in Therapy, May 22, 2019

Introduction: This exploratory study characterized the performance of a nasal dilator strip with ... more Introduction: This exploratory study characterized the performance of a nasal dilator strip with improved spring forces in lowering nasal resistance during sleep and reducing sleep-disordered breathing in subjects with difficulty sleeping due to chronic nocturnal nasal congestion. Methods: Subjects applied the strip at bedtime for 28 days (active phase; n = 70). Objective assessments included snoring variables, breathing route during sleep, and polysomnography measures compared with baseline. Nasal breathing, congestion, and sleep were measured subjectively using rating scales and questionnaires. During a crossover nasal resistance phase (n = 55), nasal resistance was measured using posterior rhinomanometry with the strip applied on one of two nights. Results: In the active phase, breathing and sleep were perceived to improve, with less daytime sleepiness (P \ 0.04) and increased ease of breathing, sleep quality, staying asleep, and feeling refreshed in the morning (all P\ 0.0001). However, while objective polysomnography metrics were generally similar with and without the strip, median wake after sleep onset time was numerically reduced by * 11 min, and the spontaneous arousal rate fell by * 37%. In the nasal resistance phase (n = 55), median resistance (at 0.2-0.25 l/s) while asleep was 39.1% lower with (n = 37) versus without (n = 36) the strip (1.34 vs. 2.20 cmH 2 O/l/s; P = 0.048). Conclusions: This exploratory study supports a role for the improved spring force nasal dilator strip in alleviating sleep-related symptoms in subjects with chronic nasal congestion, potentially via lowering nasal resistance and reducing nocturnal awakenings. A larger study is indicated to confirm these preliminary data. ClinicalTrials.gov identifier: NCT03105297.

Research paper thumbnail of Correction to: Sleep Quality and Congestion with Breathe Right Nasal Strips: Two Randomized Controlled Trials

Advances in Therapy, Sep 4, 2019

Research paper thumbnail of Effects of nasal dilator strips on subjective measures of sleep in subjects with chronic nocturnal nasal congestion: a randomized, placebo-controlled trial

Allergy, Asthma & Clinical Immunology, Aug 27, 2018

Background: This exploratory study investigated effects of a new asymmetric butterfly-shaped prot... more Background: This exploratory study investigated effects of a new asymmetric butterfly-shaped prototype nasal dilator strip and the currently marketed clear Breathe Right Nasal Strip (BRNS) on subjective measures of nasal congestion and sleep quality. Methods: In this randomized, double-blind study, subjects with chronic nasal congestion and sleep difficulties were assigned a BRNS clear strip, an asymmetric butterfly prototype, or an asymmetric butterfly placebo strip without springs, to use nightly for 2 weeks. The main outcomes included change from baseline to days 7 and 14 on the Pittsburgh Insomnia Rating Scale (PIRS), Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ), and Congestion Quantifier Seven-Item Test (CQ7). Results: The intent-to-treat population included 59 subjects. The butterfly and BRNS strips showed significant (P < 0.05) improvement versus placebo on PIRS satisfaction with sleep at day 7 [least square (LS) mean changes: − 0.7, − 0.6, and − 0.2, respectively], and the butterfly strip also showed significant improvement from baseline on this outcome versus placebo at day 14 (− 1.0 vs − 0.5). On the NRQLQ, both the butterfly prototype and BRNS clear were more effective than placebo in improving symptoms on waking at day 7 (LS mean changes: − 7.9, − 7.2, and − 4.1, respectively); the BRNS clear was significantly more effective than placebo in improving sleep problems at day 7 (− 7.4 vs − 4.2). There were no between-treatment differences on the CQ7. All strips were well tolerated. Conclusions: The asymmetric butterfly prototype and BRNS clear strip significantly improved some subjective measures of nasal congestion and sleep compared with placebo in subjects with nasal congestion and sleep difficulties. Trial registration This study is registered at ClinicalTrials.gov (identifier: NCT01122849

Research paper thumbnail of Removal of oral debris and bacteria during supervised tooth brushing

Archives of Oral Biology, Apr 1, 2008

Objective: To investigate foam generation during brushing, and the oral debris and bacteria remov... more Objective: To investigate foam generation during brushing, and the oral debris and bacteria removal efficacy of an experimental gel-to-foam dentifrice compared to a commercially-available dentifrice after brushing. Methods: Thirty-four subjects participated in this blinded, crossover study. After a wash-out period prior to each session of product use, subjects reported to the site having abstained from oral hygiene, eating and drinking from 22:00 h on the evening prior to treatment visits. The subjects brushed with a weighed dose of assigned paste and were asked to expectorate their toothpaste slurry into a collection vessel at 30 and 60 seconds during supervised brushing. The expectorated foam was measured immediately, after which subjects rinsed with 10 ml of sterile water and expectorated into the same vessel. Samples were placed on ice and immediately transported to the laboratory for analysis. Bacteria (total anaerobes and VSC-producing bacteria) were enumerated using appropriate selective media. To calculate the amount of debris, a measured portion of the sample was deposited onto a pre-weighed dish and weighed. Dishes were dried thoroughly and weighed again after cooling. Results: Use of the gel-to-foam dentifrice resulted in 105% greater foam volume compared with use of the control dentifrice (p < 0.0001). Further, the gel-to-foam dentifrice removed 15.77% more debris than the control dentifrice (p-value = 0.0342). There was greater removal of total anaerobes and VSC-producing bacteria by the gel-to-foam dentifrice versus the control dentifrice (p-value < 0.0001). Conclusion: Single use of a gel-to-foam dentifrice generated a greater volume of foam and removed a greater amount of oral debris and bacteria during brushing than a standard dentifrice.

Research paper thumbnail of Single-Dose Bioequivalence of Two Mini Nicotine Lozenge Formulations

Clinical pharmacology in drug development, Nov 28, 2017

Diverse nicotine replacement therapy options may improve consumer usage. This study was conducted... more Diverse nicotine replacement therapy options may improve consumer usage. This study was conducted to establish the bioequivalence of a new cherry-flavored mini lozenge with that of a currently marketed mint-flavored mini lozenge. The rate (C max) and extent (AUC 0-t) of plasma nicotine absorption were compared after administration of 2-and 4-mg doses of each lozenge in healthy adult smokers (n = 43). The bioequivalence of each respective dose was established based on the 90% confidence interval for the ratio of geometric means for both C max and AUC 0-t lying within the range of 0.80 to 1.25. Adverse-event profiles were similar between formulations.

Research paper thumbnail of Patients’ experience and utilization patterns of diclofenac gel in Germany: a real-world study with a prospective longitudinal survey and a retrospective analysis of pharmacy data

Current Medical Research and Opinion

Research paper thumbnail of MOESM4 of Effects of nasal dilator strips on subjective measures of sleep in subjects with chronic nocturnal nasal congestion: a randomized, placebo-controlled trial

Additional file 4: Table S4. Subject diary ratings of breathing before and after strip removal up... more Additional file 4: Table S4. Subject diary ratings of breathing before and after strip removal upon awakening (ITT population).

Research paper thumbnail of MOESM3 of Effects of nasal dilator strips on subjective measures of sleep in subjects with chronic nocturnal nasal congestion: a randomized, placebo-controlled trial

Additional file 3: Table S3. Subject diary ratings of nasal stuffiness before and after strip rem... more Additional file 3: Table S3. Subject diary ratings of nasal stuffiness before and after strip removal upon awakening (ITT population).

Research paper thumbnail of MOESM2 of Effects of nasal dilator strips on subjective measures of sleep in subjects with chronic nocturnal nasal congestion: a randomized, placebo-controlled trial

Additional file 2: Table S2. Subjects showing any improvement on the daily diary questions after ... more Additional file 2: Table S2. Subjects showing any improvement on the daily diary questions after strip application on night 1.

Research paper thumbnail of MOESM1 of Effects of nasal dilator strips on subjective measures of sleep in subjects with chronic nocturnal nasal congestion: a randomized, placebo-controlled trial

Additional file 1: Table S1. Composite PIRS measures in subgroup of subjects at risk for sleep ap... more Additional file 1: Table S1. Composite PIRS measures in subgroup of subjects at risk for sleep apnea (ITT population).

Research paper thumbnail of Evaluating the Moisturizing Abilities and Sun Protection Factor of New Lip Balm Formulations

Journal of cosmetic science, 2019

This report explores dry-skin models to assess the potential of a new lip balm formulation to hyd... more This report explores dry-skin models to assess the potential of a new lip balm formulation to hydrate dry skin or lips, and presents sun protection factor (SPF) values for five new lip balm formulations. Evaporimeter [for transepidermal water loss (TEWL)], Skicon®, and Corneometer® were used to measure hydrating effects of lip balm formulations in a dry-skin leg model, and TEWL, DermaLab® Moisture Meter, Corneometer®, and visual assessments were used with a dry-lip model. SPF studies were conducted in accordance with either the U.S. Food and Drug Administration monograph final rule or international standard ISO 24444. Data from dry-skin leg model demonstrate that a new lip balm formulation significantly improves skin hydration compared with untreated leg skin and four comparator products. Data obtained from a dry-lip model proved unreliable. Five new lip balm formulations exhibited sunscreen capability; however, they did not meet the intended SPF. There were no product-related adver...

Research paper thumbnail of A series of in vitro and human studies of a novel lip cream formulation for protecting against environmental triggers of recurrent herpes labialis

Clinical, Cosmetic and Investigational Dermatology, 2019

Purpose: These studies describe the testing of a novel, daily-use lip cream designed for individu... more Purpose: These studies describe the testing of a novel, daily-use lip cream designed for individuals with lips prone to recurrent herpes labialis (RHL) that protects against environmental triggers. Subjects and methods: In vitro occlusive and in vitro and in vivo photoprotection analyses, a characterization of normal vs dry lips, and a randomized, evaluator-blinded, clinical trial that assessed the lip cream in healthy subjects with dry lips were conducted. In the clinical trial, subjects applied the lip cream or were untreated and evaluated using transepidermal water loss (TEWL), corneometry, visual assessments of lip dryness, expert photographic evaluations, and subject-rated outcomes. Results: The lip cream's in vitro water vapor transmission rate (84.1 g/(m 2 h)) indicated moderate occlusivity. The lip cream, but not placebo or control (water), reduced ultraviolet A (UVA)-and UVB-induced DNA damage, and tumor necrosis factor-α (EpiDerm FT) and prostaglandin E 2 release (EpiDerm FT and EpiGingival™). The lip cream's in vivo sun protection factor (SPF) was 12.2 (lower confidence limit, 11.3) and SPF/UVA protection factor ratio was 0.9. The characterization of dry vs normal lips identified differences in moisturization. In the clinical trial, the lip cream significantly decreased TEWL (

Research paper thumbnail of Nicotine Lozenges in the Relief of Behaviorally Provoked Craving

American Journal of Health Behavior, 2018

Objectives: Environmental cues may precipitate nicotine cravings in smokers. We present 2 studies... more Objectives: Environmental cues may precipitate nicotine cravings in smokers. We present 2 studies exploring the efficacy of nicotine mini lozenges to reduce nicotine craving in smokers following behavioral provocation. Methods: Healthy smokers aged ≥18 years enrolled. In Study 1, participants were stratified by number of cigarettes smoked daily; Study 2 enrolled only heavy smokers. After an abstinence period, participants engaged in behavioral provocation to induce nicotine craving before receiving a nicotine mini lozenge (Study 1: 1.5 mg or 4 mg; Study 2: 4 mg) or matching placebo. Craving was assessed using a 100-mm visual analogue scale, and safety was monitored. Results: In Study 1, neither nicotine mini lozenge dose significantly reduced craving in smokers versus placebo. In Study 2, 4-mg nicotine mini lozenges significantly reduced craving scores 5 minutes post-treatment (least-square mean [LSM] change from baseline: −41.8; 95% confidence interval [CI]: −45.8, −37.7) versus placebo (−25.9; 95% CI: −30.0, −21.8; p < .001). Adverse events were infrequent, mild in intensity, and more common with the 4-mg nicotine mini lozenges. Conclusions: Behaviorally provoked nicotine craving can be significantly and safely reduced in heavy/high-dependency smokers with 4-mg nicotine mini lozenges.

Research paper thumbnail of Randomized Trials of Nasal Patency and Dermal Tolerability With External Nasal Dilators in Healthy Volunteers

Allergy & Rhinology, 2018

Background External nasal dilator strips are used as nonpharmacological therapy to reduce snoring... more Background External nasal dilator strips are used as nonpharmacological therapy to reduce snoring and daytime sleepiness. In a product improvement initiative, a marketed strip (BRNS) and 2 prototype nasal strips were evaluated. Objective To compare the nasal patency and multiple-use dermal tolerability of the BRNS and prototype nasal strips using both objective and subject-reported outcome measures. Methods Two studies were conducted separately in healthy volunteers ≥18 years of age. A single-day nasal patency randomized crossover study assessed minimal cross-sectional area (MCA; second restriction) and nasal volume (using acoustic rhinometry); nasal inspiratory flow and resistance (using posterior rhinomanometry); and subject-reported evaluations of the BRNS compared with the butterfly strip and teardrop strip prototypes. A single-center, randomized, controlled, parallel-group, evaluator-blinded study assessed dermal tolerability of the BRNS and the butterfly strip over 7 consecuti...

Research paper thumbnail of Correction to: Sleep Quality and Congestion with Breathe Right Nasal Strips: Two Randomized Controlled Trials

Advances in Therapy, 2019

Research paper thumbnail of Correction to: Objective and Subjective Effects of a Prototype Nasal Dilator Strip on Sleep in Subjects with Chronic Nocturnal Nasal Congestion

Advances in Therapy, 2019