- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00284856
Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED)
January 31, 2022 updated by: Organon and Co
A Multicenter, Randomized, Double-Blind, Parallel-Group 6-Month Study to Evaluate the Efficacy and Safety of Oral Montelukast Sodium, Fluticasone Propionate and Placebo in Patients With Chronic Asthma Who Smoke Cigarettes
This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in participants with chronic asthma who actively smoke cigarettes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1640
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants with chronic asthma who actively smoke at least 0.5 to no more than 2 packs of cigarettes a day
Exclusion Criteria:
- Participant cannot have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or emphysema.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Arm 1: Montelukast
|
montelukast 10 mg tablet once daily, 6 month treatment period
fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period
montelukast 10 mg Pbo tablet once daily, 6 month treatment period
|
Active Comparator: 2
Arm 2: Fluticasone
|
fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period
montelukast 10 mg Pbo tablet once daily, 6 month treatment period
fluticasone propionate 250 mcg twice daily, 6 month treatment period
|
Placebo Comparator: 3
Arm 3: Placebo
|
fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period
montelukast 10 mg Pbo tablet once daily, 6 month treatment period
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Asthma-control Days Over the 6-month Treatment Period
Time Frame: 6 months
|
An asthma-control day, computed from daily diaries, was any day with no unscheduled visit for asthma care, no use of > than 2 puffs of β-agonist, no use of other asthma rescue medication, and no nocturnal awakening.
The percentage of asthma-control days was the number of days with asthma-control divided by the total number of days with non-missing values for this endpoint.
The patient diary had questions concerning daytime and nighttime symptoms, morning (AM) and evening (PM) peak expiratory flow rate (PEFR), β-agonist use, asthma attacks and smoking activity.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period
Time Frame: Baseline and 6 months
|
4 daytime symptoms were evaluated daily on a 7-point scale from 0 (best)- 6 (worst).
The on-treatment daytime symptom score was computed by averaging over Period II the mean of the 4 daily symptom scores recorded daily in the diary while the baseline daytime symptom score was obtained by averaging the mean of the 4 daily symptom scores across the daily diary entries of the Baseline period (Period I).
The change from baseline in mean daytime symptom score is computed as the difference between the mean on-treatment daytime symptom score & the mean baseline daytime symptom score.
|
Baseline and 6 months
|
Change From Baseline in Average Morning (AM) PEFR (Peak Expiratory Flow Rate) Over a 6-month Treatment Period
Time Frame: Baseline and 6 months
|
PEFR measurements were performed daily, in the morning before using any medication.
The on-treatment AM PEFR was computed by averaging over Period II (treatment period) the AM PEFR recorded daily in the diary, while the baseline AM PEFR was obtained by averaging the AM PEFR across the daily diary entries of the Baseline Period or Period I (placebo run-in period).
The change from baseline in average AM PEFR is computed as the difference between mean on-treatment AM PEFR and mean baseline AM PEFR.
|
Baseline and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
April 1, 2010
Study Registration Dates
First Submitted
January 31, 2006
First Submitted That Met QC Criteria
January 31, 2006
First Posted (Estimate)
February 1, 2006
Study Record Updates
Last Update Posted (Actual)
February 7, 2022
Last Update Submitted That Met QC Criteria
January 31, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Leukotriene Antagonists
- Hormone Antagonists
- Cytochrome P-450 CYP1A2 Inducers
- Cytochrome P-450 Enzyme Inducers
- Anti-Allergic Agents
- Montelukast
- Fluticasone
Other Study ID Numbers
- 0476-332
- 2005_108
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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