Clinical trial NCT00911547: The Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients (0476-029)
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, 2-Period, Parallel-Group Study to Assess the Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: chronic asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-06-02
Enrollment: 642
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the additive effect of montelukast (MK0476) taken along with inhaled beclomethasone versus inhaled beclomethasone alone.


Eligibility criteria: Inclusion Criteria:

* Female patients tested negative for pregnancy and agreed to use appropriate contraceptives through out the study
* Patient was a nonsmoker
* Patient was in good general health (except for asthma)

Exclusion Criteria:

* Patient was hospitalized
* Patient was female who was less than 8 weeks postpartum or breast feeding
* Patient planned to move or vacation away during the study
* Patient had major surgery within 4 weeks the past 4 weeks
* Patient has donated blood or participated in a clinical trial within the past 4 weeks
* Patient was a regular user or recent abuser of alcohol or illicit drugs
* Patient was 40% over or under normal weight for height

Primary outcomes:
measure: Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma
timeFrame: Baseline & over 16 weeks for the Beclomethasone (Beclo) and Montelukast (MK) + Beclo groups and over last 10 weeks for the Placebo and MK groups
measure: Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma
timeFrame: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups
Secondary outcomes:
measure: Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use
timeFrame: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups
measure: Mean Change From Baseline in Morning Peak Flow Rate (PEFR) in Patients With Chronic Asthma
timeFrame: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups
measure: Mean Change From Baseline in Nocturnal Asthma Score on the Overnight Asthma Symptoms Diary in Nocturnal Asthmatic Patients Only
timeFrame: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Laviolette M, Malmstrom K, Lu S, Chervinsky P, Pujet JC, Peszek I, Zhang J, Reiss TF. Montelukast added to inhaled beclomethasone in treatment of asthma. Montelukast/Beclomethasone Additivity Group. Am J Respir Crit Care Med. 1999 Dec;160(6):1862-8. doi: 10.1164/ajrccm.160.6.9803042.