AsthmaPhase 3NCT00284856

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

A Phase 3 study testing montelukast sodium and Comparator: fluticasone in people with Asthma, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Asthma
What is being tested?: montelukast sodium and Comparator: fluticasone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,640 participants
Where: No sites listed yet
Study dates: May 2006to Apr 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Participants with chronic asthma who actively smoke at least 0.5 to no more than 2 packs of cigarettes a day

Who cannot join

Participant cannot have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or emphysema.

About this study

Official title: 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.

Conditions: Asthma
Being tested: montelukast sodium, Comparator: Placebo, Comparator: fluticasone
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

montelukast sodiumDrug
montelukast 10 mg tablet once daily, 6 month treatment period
Comparator: PlaceboDrug
fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period
Comparator: fluticasoneDrug
fluticasone propionate 250 mcg twice daily, 6 month treatment period
Comparator: PlaceboDrug
montelukast 10 mg Pbo tablet once daily, 6 month treatment period

Study groups in NCT00284856
Study group	Role	What they receive
1	Experimental	Arm 1: Montelukast Receives: Drug: montelukast sodium; Drug: Comparator: Placebo
2	Active comparator	Arm 2: Fluticasone Receives: Drug: Comparator: fluticasone; Drug: Comparator: Placebo
3	Placebo comparator	Arm 3: Placebo Receives: Drug: Comparator: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Asthma-control Days Over the 6-month Treatment Period
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.
Measured: 6 months

Secondary outcomes (2)

Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period
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.
Measured: Baseline and 6 months
Change From Baseline in Average Morning (AM) PEFR (Peak Expiratory Flow Rate) Over a 6-month Treatment Period
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.
Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2006Apr 2010

First posted1 Feb 2006 (estimated)
Study startMay 2006
Primary completionApr 2010
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,640 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00284856
Sponsor's protocol ID: 0476-332
Other IDs: 2005_108
Status last verified: Jan 2022
First submitted: 31 Jan 2006
Last updated: 10 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 23380218

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00284856
Acronym / sponsor ID: 0476-332
Conditions: Asthma
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,640 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: May 2006
Primary completion: Apr 2010 (actual)
Study completion: Apr 2010 (actual)
First posted: 1 Feb 2006 (estimated)
Results: Posted 3 May 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: montelukast sodium, Drug: Comparator: PlaceboArm 1: Montelukast
2	Active comparator	Drug: Comparator: fluticasone, Drug: Comparator: PlaceboArm 2: Fluticasone
3	Placebo comparator	Drug: Comparator: PlaceboArm 3: Placebo

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Participants with chronic asthma who actively smoke at least 0.5 to no more than 2 packs of cigarettes a day

Key exclusion criteria (1 listed)

Participant cannot have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or emphysema.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
montelukast sodiummontelukast 10 mg tablet once daily, 6 month treatment period	Drug	1
Comparator: Placebofluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period	Drug	1, 3
Comparator: fluticasonefluticasone propionate 250 mcg twice daily, 6 month treatment period	Drug	2
Comparator: Placebomontelukast 10 mg Pbo tablet once daily, 6 month treatment period	Drug	2, 3

Primary outcome

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.

2 secondary outcomes

Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period
Time frame: 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

Results and safety

Results posted to the registry on 3 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Montelukast	347	296
Fluticasone	336	286
Placebo	336	276

Primary outcome: Percentage of Asthma-control Days Over the 6-month Treatment Period

Time frame: 6 months. Mean (Standard Deviation). Unit: Percentage of days

Measure	Montelukast n = 334	Fluticasone n = 329	Placebo n = 323
Value	50.70 (38.19)	53.30 (39.06)	43.84 (38.08)

Montelukast vs Placebo: Least Squares Mean Difference: 5.92 (95% CI 0.28 to 11.56)
Fluticasone vs Placebo: Least Squares Mean Difference: 10.14 (95% CI 4.50 to 15.78)
Montelukast vs Fluticasone: Least Squares Mean Difference: -4.22 (95% CI -9.83 to 1.38)

Population analysed: Efficacy analysis was based on the full analysis set (FAS) population which included all participants who had at least 7 days of on-treatment data for the specific endpoint. Thirty three patients were excluded from the FAS (13 on montelukast, 7 on fluticasone and 13 on placebo). One participant in the placebo group did not take study medication.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Montelukast	9 of 347 (2.6%)	65 of 347 (18.7%)	Not reported
Fluticasone	10 of 336 (3%)	57 of 336 (17%)	Not reported
Placebo	11 of 335 (3.3%)	72 of 335 (21.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23380218Price 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.
Individual participant dataSharing planned: No

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
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RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
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RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
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Active, not recruitingPhase 2/3
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RecruitingPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing montelukast sodium and Comparator: fluticasone in people with Asthma, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Asthma-control Days Over the 6-month Treatment Period (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00284856, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.