MedDataX Logo

Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED)

NCT ID: NCT00284856

Last Updated: 2024-05-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1640 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2010-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a multicenter study to evaluate the efficacy and safety of MK0476 versus placebo in participants with chronic asthma who actively smoke cigarettes.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effects of Montelukast on Smokers With Asthma

NCT00712335

Asthmatic Smokers Non-asthmatic Smokers
COMPLETED PHASE4

A Study to Assess the Effect of Montelukast Sodium With Concomitant Administration of Inhaled Budesonide in Asthmatic Patients (0476-075)

NCT00140946

Asthma
COMPLETED PHASE4

Study of an Approved Drug in Patients With Asthma (0476-289)(COMPLETED)

NCT00092144

Asthma
COMPLETED PHASE3

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Montelukast (MK-0476) in Participants With Mild or Moderate Asthma (MK-0476-380 AM3)(COMPLETED)

NCT00636207

Asthma
COMPLETED PHASE1

The Safety and Effectiveness of MK0476 (Montelukast) in Patients With Chronic Asthma (0476-388)

NCT00739297

Chronic Asthma
COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Arm 1: Montelukast

Group Type EXPERIMENTAL

montelukast sodium

Intervention Type DRUG

montelukast 10 mg tablet once daily, 6 month treatment period

Comparator: Placebo

Intervention Type DRUG

fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period

2

Arm 2: Fluticasone

Group Type ACTIVE_COMPARATOR

Comparator: fluticasone

Intervention Type DRUG

fluticasone propionate 250 mcg twice daily, 6 month treatment period

Comparator: Placebo

Intervention Type DRUG

montelukast 10 mg Pbo tablet once daily, 6 month treatment period

3

Arm 3: Placebo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type DRUG

fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period

Comparator: Placebo

Intervention Type DRUG

montelukast 10 mg Pbo tablet once daily, 6 month treatment period

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

montelukast sodium

montelukast 10 mg tablet once daily, 6 month treatment period

Intervention Type DRUG

Comparator: Placebo

fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period

Intervention Type DRUG

Comparator: fluticasone

fluticasone propionate 250 mcg twice daily, 6 month treatment period

Intervention Type DRUG

Comparator: Placebo

montelukast 10 mg Pbo tablet once daily, 6 month treatment period

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Organon and Co

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Explore related publications, articles, or registry entries linked to this study.

Price D, Popov TA, Bjermer L, Lu S, Petrovic R, Vandormael K, Mehta A, Strus JD, Polos PG, Philip G. Effect of montelukast for treatment of asthma in cigarette smokers. J Allergy Clin Immunol. 2013 Mar;131(3):763-71. doi: 10.1016/j.jaci.2012.12.673. Epub 2013 Feb 4.

Reference Type RESULT
PMID: 23380218 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2005_108

Identifier Type: -

Identifier Source: secondary_id

0476-332

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Study to Evaluate MK0476 and Fluticasone to Control Asthma in Patients With Mild Persistent Asthma (0476-910)
NCT00489346 COMPLETED PHASE3
Chronic Asthma Study in 2- to 5-Year-Old Patients (MK0476-072 )
NCT00968201 COMPLETED PHASE3
Acute Montelukast in Asthma
NCT01011452 COMPLETED PHASE4
A Study of MK0476 in the Treatment of Asthma Patients Aged 2-5 Years (0476-907)
NCT00700661 COMPLETED PHASE3
MK0476 Study in Adult Patients With Acute Asthma (0476-322)
NCT00229970 COMPLETED PHASE3
A Study of Montelukast (MK-0476) Compared With Fluticasone in Pediatric Participants With Chronic Asthma (MK-0476-303)
NCT00540839 WITHDRAWN PHASE3
The Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients (0476-029)
NCT00911547 COMPLETED PHASE3
Study of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma (0476-386)
NCT00666679 COMPLETED PHASE2
Montelukast in Pediatric Allergic Asthma (0476-336)(COMPLETED)
NCT00289874 COMPLETED PHASE3
Study of MK-0476 in Adult Patients With Acute Asthma (0476-334)
NCT00442338 COMPLETED PHASE3
Two Investigational Drugs in the Prevention of Airway Constriction Brought on by Exercise in Participants With Asthma (0476-911)
NCT00127166 COMPLETED PHASE3
Montelukast in Pediatric Patients Aged 6 to 24 Months With Asthma--Safety Study (0476-176)
NCT00943683 COMPLETED NA
Montelukast Back to School Asthma Study (0476-340)
NCT00461032 COMPLETED PHASE3
A Study To Assess The Effect Of PF-03893787 On Lung Function Following An Allergen Challenge In Asthmatic Subjects
NCT00856687 COMPLETED PHASE1
MK0524 Asthma POC Study (0524-008)(COMPLETED)
NCT00783601 COMPLETED PHASE2
A Study to Determine the Effect of Montelukast Sodium as an Episode Modifier in the Treatment of Infrequent Episodic Asthma in Children (0476-165)
NCT00140881 COMPLETED PHASE4
To Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy (0476-366)
NCT00398151 COMPLETED PHASE3
A Study to Evaluate the Effectiveness of JNJ 40929837 for the Treatment of Asthma Using a Bronchial Allergen Challenge Model
NCT01241422 COMPLETED PHASE2
Montelukast Compared With Placebo and Salmeterol in Exercise-Induced Bronchoconstriction (0476-316)
NCT00245570 COMPLETED PHASE3
Study to Evaluate the Inflammatory Cells Activity in Patients With Persistent Asthma Treated With Montelukast (0476-403)(COMPLETED)
NCT00770900 COMPLETED PHASE4
Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma
NCT00543686 COMPLETED PHASE2
A Study to Compare Effectiveness of Montelukast Sodium With Comparator in Mild to Moderate Persistent Asthmatics (0476-329)
NCT00157937 COMPLETED PHASE4
Effect of Montelukast in Asthma in Children
NCT01266772 UNKNOWN PHASE3
Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232)
NCT00943397 COMPLETED PHASE3
Study of MK-1029 in Participants With Persistent Asthma That Cannot Be Controlled With Montelukast (MK-1029-015)
NCT02720081 COMPLETED PHASE2