The Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients (0476-029)

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: montelukast sodium; Drug: beclomethasone; Drug: Placebo inhaler; Drug: placebo tablet

• Registration Number: NCT00911547
• Lead Sponsor: Organon and Co

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 1995-03
• Primary Completion: 1996-04
• Study Completion: 1996-05
• Study First Submitted: 2009-05-29
• Study First Submitted QC: 2009-06-01
• Study First Posted: 2009-06-02
• Results First Submitted: 2009-07-24
• Results First Submitted QC: 2010-05-17
• Results First Posted: 2010-06-09
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 642

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo inhaler	Montelukast + Placebo inhaler
3	placebo tablet	Placebo tablet + Beclomethasone
4	Placebo inhaler	Placebo tablet + Placebo inhaler
1	montelukast sodium	Montelukast + Beclomethasone
2	montelukast sodium	Montelukast + Placebo inhaler
3	beclomethasone	Placebo tablet + Beclomethasone
4	placebo tablet	Placebo tablet + Placebo inhaler
1	beclomethasone	Montelukast + Beclomethasone

Primary Outcome Measures

Name	Time	Method
Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma	Baseline & over 16 weeks for the Beclomethasone (Beclo) and Montelukast (MK) + Beclo groups and over last 10 weeks for the Placebo and MK groups	Mean percent change from baseline in FEV1 in patients with chronic asthma averaged over 16 weeks for the Beclo and MK+ Beclo groups and averaged over last 10 weeks for the Placebo and MK groups
Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma	Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups	The daily daytime symptom score was determined by averaging the daily scores (the patient scored his/her symptoms \[from 0 (best) to 6 (worst)\] on a daily basis.) for the four questions on the Daytime Asthma Symptoms Diary.; The average daytime symptom score for the visit was determined by averaging the daily symptom scores over all days between two consecutive visits.

Secondary Outcome Measures

Name	Time	Method
Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use	Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups	Beta-agonist medication use from the daytime and overnight asthma symptoms diaries for each 24-hour period was added to determine the daily total number of puffs used. The average daily number of puffs for the visit was determined as the average daily number of puffs over all days between consecutive visits.
Mean Change From Baseline in Nocturnal Asthma Score on the Overnight Asthma Symptoms Diary in Nocturnal Asthmatic Patients Only	Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups	Mean change from baseline in Nocturnal asthma score; the patient scored his/her symptoms \[from 0 (best) to 3 (worst)\] on a daily basis. Responses to the question, "Did you wake up with asthma symptoms?" (no, once, more than once, awake "all night"), were assigned numerical values (0, 1, 2, 3, respectively).; The average score for the visit was determined by averaging the daily scores over all days between consecutive visits.
Mean Change From Baseline in Morning Peak Flow Rate (PEFR) in Patients With Chronic Asthma	Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups	Morning PEFR was measured in triplicate immediately upon arising before taking any medication and the best value recorded on the overnight asthma symptoms diary. The mean morning PEFR for the visit was determined by averaging all valid PEFR measurements for the days between consecutive visits.