Tag: subjects

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Chronic Dosing, Cross-Over Study to Assess the Efficacy and Safety of Budesonide (PT008) in Adult Subjects With Mild to Moderate Persistent Asthma

Condition:   Asthma
Interventions:   Drug: Budesonide Inhalation Aerosol (PT008) Dose 1;   Drug: Budesonide Inhalation Aerosol (PT008) Dose 2;   Drug: Budesonide Inhalation Aerosol (PT008) Dose 3;   Drug: Budesonide Inhalation Aerosol (PT008) Dose 4;   Drug: Placebo
Sponsor:   Pearl Therapeutics, Inc.
Not yet recruiting – verified April 2014

View full post on ClinicalTrials.gov: asthma | received in the last 14 days

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A Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Condition:   Pulmonary Disease, Chronic Obstructive
Interventions:   Drug: Umeclidinium bromide/Vilanterol;   Drug: Placebo ACCUHALER/DISKUS;   Drug: Fluticasone propionate/Salmeterol;   Drug: Placebo NDPI
Sponsors:   GlaxoSmithKline;   GlaxoSmithKline
Not yet recruiting – verified April 2013

View full post on ClinicalTrials.gov: asthma | received in the last 14 days

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Safety and efficacy of once-daily treatment with beclomethasone dipropionate nasal aerosol in subjects with perennial allergic rhinitis.

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Safety and efficacy of once-daily treatment with beclomethasone dipropionate nasal aerosol in subjects with perennial allergic rhinitis.

Allergy Asthma Proc. 2012 May-Jun;33(3):249-57

Authors: Meltzer EO, Jacobs RL, LaForce CF, Kelley CL, Dunbar SA, Tantry SK

Abstract
Intranasal corticosteroids are recommended as first-line therapy for the treatment of the symptoms of persistent allergic rhinitis (AR). Since the phase-out of chlorofluorocarbon nasal aerosols, intranasal corticosteroids have been available only as aqueous nasal sprays. This study was designed to assess the efficacy, safety, and quality-of-life benefits of beclomethasone dipropionate (BDP) hydrofluoroalkane nasal aerosol in subjects with perennial AR (PAR). After a 7- to 21-day placebo run-in period, eligible subjects aged â�¥12 years with PAR were randomized to 6 weeks of once-daily treatment with BDP nasal aerosol at 320 �¼g or placebo. Reflective and instantaneous total nasal symptom scores (rTNSS and iTNSS, respectively), Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score, and physician-assessed total nasal symptom score were evaluated. The primary end point was change from baseline in average morning (A.M.) and evening (P.M.) subject-reported rTNSS over the 6-week treatment period. Safety and tolerability were also assessed. Treatment with BDP nasal aerosol showed significantly greater improvement in average A.M. and P.M. rTNSS compared with placebo (mean treatment difference, -0.84; 95% confidence interval, -1.2, -0.5; p < 0.001). Greater improvements in rTNSS were reported as early as day 1 and were maintained throughout the 6-week treatment period with the exception of day 2. Greater improvements were seen for all four individual nasal symptoms (nasal congestion, nasal itching, rhinorrhea, and sneezing) with BDP nasal aerosol compared with placebo. Similarly, significant improvements were seen in average A.M. and P.M. iTNSS (p < 0.001) and RQLQ score (p = 0.001) with BDP nasal aerosol compared with placebo. In addition, BDP nasal aerosol treatment was well tolerated, and its safety profile was comparable to that of placebo. This clinical study indicated that treatment with BDP nasal aerosol provides statistically significant and clinically meaningful nasal symptom relief accompanied by improved quality of life in subjects with PAR. Additionally, treatment with BDP nasal aerosol was well tolerated with a safety profile comparable to that of placebo. This study was part of the clinical trial NCT01134705 registered in www.ClinicalTrials.gov.

PMID: 22737708 [PubMed – in process]

View full post on pubmed: asthma