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CompletedNCT00284856Updated May 10, 2024Results posted

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

A Phase 3 interventional study of montelukast sodium and Comparator: Placebo in Asthma, sponsored by Organon and Co. Completed. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2024-05-10.

Sponsored by Organon and Co · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,640
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Asthma

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03

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 1,640 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

Organon and Co is the lead sponsor of 478 studies on the registry; none are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Participant cannot have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or emphysema.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,640 participants (actual)

Study arms

  • Experimental
    1

    Arm 1: Montelukast

    Drug: montelukast sodium · Drug: Comparator: Placebo

  • Active comparator
    2

    Arm 2: Fluticasone

    Drug: Comparator: fluticasone · Drug: Comparator: Placebo

  • Placebo comparator
    3

    Arm 3: Placebo

    Drug: Comparator: Placebo

Interventions

  • Drugmontelukast sodium

    montelukast 10 mg tablet once daily, 6 month treatment period

  • DrugComparator: Placebo

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

  • DrugComparator: fluticasone

    fluticasone propionate 250 mcg twice daily, 6 month treatment period

  • DrugComparator: Placebo

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: Baseline and 6 months

  2. 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.

    Time frame: Baseline and 6 months

07

Results

Posted May 3, 2011

Participant flow

Participant flow — Overall Study
MilestoneMontelukastFluticasonePlacebo
Started347336336
Completed296286276
Not completed515060
Withdrew: Adverse event333
Withdrew: Lack of efficacy218
Withdrew: Lost to follow-up252122
Withdrew: Protocol violation545
Withdrew: Withdrawal by subject121618
Withdrew: Other454

Outcome measures

PrimaryPercentage 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.

Time frame:
6 months
Reported as:
Mean · Percentage of days
Percentage of Asthma-control Days Over the 6-month Treatment Period
Percentage of daysMontelukastFluticasonePlacebo
Percentage of Asthma-control Days Over the 6-month Treatment Period50.70 ± 38.1953.30 ± 39.0643.84 ± 38.08
Statistical analysis
  • Montelukast vs Placebo · Least squares mean difference: 5.92 · 95% CI 0.28 to 11.56Estimated Value is difference in least squares mean (montelukast - placebo)
  • Fluticasone vs Placebo · Least squares mean difference: 10.14 · 95% CI 4.50 to 15.78Estimated value is difference in least squares mean (fluticasone - placebo)
  • Montelukast vs Fluticasone · Least squares mean difference: -4.22 · 95% CI -9.83 to 1.38Estimated value is difference in least squares mean (montelukast - fluticasone)
SecondaryChange 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.

Time frame:
Baseline and 6 months
Reported as:
Mean · Score on a scale
Change From Baseline in Mean Daytime Symptom Score Over a 6-month Treatment Period
Score on a scaleMontelukastFluticasonePlacebo
Baseline1.82 ± 1.031.78 ± 0.971.90 ± 0.94
Average Change from Baseline During Period II-0.41 ± 0.70-0.44 ± 0.68-0.27 ± 0.72
Statistical analysis
  • Montelukast vs Placebo · Least squares mean difference: -0.15 · 95% CI -0.25 to -0.05Estimated value is difference in least squares mean (montelukast - placebo)
  • Fluticasone vs Placebo · Least squares mean difference: -0.20 · 95% CI -0.30 to -0.10Estimated value is difference in least squares mean (fluticasone - placebo)
  • Montelukast vs Fluticasone · Least squares mean difference: 0.05 · 95% CI -0.05 to 0.15Estimated value is difference in least squares mean (montelukast - fluticasone)
SecondaryChange 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.

Time frame:
Baseline and 6 months
Reported as:
Mean · Liters/minute
Change From Baseline in Average Morning (AM) PEFR (Peak Expiratory Flow Rate) Over a 6-month Treatment Period
Liters/minuteMontelukastFluticasonePlacebo
Baseline363.75 ± 112.40354.28 ± 101.64347.98 ± 99.21
Average Change from Baseline During Period II12.84 ± 40.2219.31 ± 44.858.27 ± 40.70
Statistical analysis
  • Montelukast vs Placebo · Least squares mean difference: 5.09 · 95% CI -1.27 to 11.45Estimated value is difference in least squares mean (montelukast - placebo)
  • Fluticasone vs Placebo · Least squares mean difference: 11.21 · 95% CI 4.85 to 17.58Estimated value is difference in least squares mean (fluticasone - placebo)
  • Montelukast vs Fluticasone · Least squares mean difference: -6.13 · 95% CI -12.46 to 0.20Estimated value is difference in least squares mean (montelukast - fluticasone)

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Montelukast—9/347 (2.6%)65/347 (18.7%)
Fluticasone—10/336 (3%)57/336 (17%)
Placebo—11/335 (3.3%)72/335 (21.5%)
Most frequent serious events
Showing 10 of 25
Most frequent serious events
EventMontelukastFluticasonePlacebo
Accidental overdoseInjury, poisoning and procedural complications0/3472/3366/335
AsthmaRespiratory, thoracic and mediastinal disorders1/3472/3362/335
Hiatus herniaGastrointestinal disorders0/3470/3361/335
AppendicitisInfections and infestations0/3470/3361/335
Respiratory tract infectionInfections and infestations0/3470/3361/335
Intentional overdoseInjury, poisoning and procedural complications0/3470/3361/335
Rib fractureInjury, poisoning and procedural complications0/3470/3361/335
Cardiac arrestCardiac disorders0/3471/3360/335
HaemorrhoidsGastrointestinal disorders0/3471/3360/335
Autoimmune hepatitisHepatobiliary disorders0/3471/3360/335
Most frequent other events
Most frequent other events
EventMontelukastFluticasonePlacebo
AsthmaRespiratory, thoracic and mediastinal disorders45/34734/33657/335
NasopharyngitisInfections and infestations23/34727/33622/335

Baseline characteristics

Age, Continuous
Age, Continuous(years)MontelukastFluticasonePlaceboTotal
Mean37.7 ± 10.438.4 ± 10.737.9 ± 9.938.0 ± 10.3
Sex: Female, Male
Sex: Female, Male(Participants)MontelukastFluticasonePlaceboTotal
Female163147166476
Male184189170543
08

Study locations

No study locations are listed for this record.

09

References and documents

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 ↗

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00284856
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Feb 1, 2006
Start date
May 2006
Primary completion
Apr 2010
Completion
Apr 2010
Results posted
May 3, 2011
Last update
May 10, 2024

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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