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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00284856
First Posted: February 1, 2006
Last Update Posted: April 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
January 31, 2006
February 1, 2006
April 6, 2011
May 3, 2011
April 6, 2017
May 2006
April 2010   (Final data collection date for primary outcome measure)
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.
Evaluate the treatment effect on asthma-control days at 6 months.
Complete list of historical versions of study NCT00284856 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Patient can not have a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or emphysema.
Not Provided
Not Provided
 
Montelukast Asthmatic Smoker Study (0476-332)(COMPLETED)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: montelukast sodium
    montelukast 10 mg tablet once daily, 6 month treatment period
  • Drug: Comparator: Placebo
    fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period
  • Drug: Comparator: fluticasone
    fluticasone propionate 250 mcg twice daily, 6 month treatment period
  • Drug: Comparator: Placebo
    montelukast 10 mg Pbo tablet once daily, 6 month treatment period
  • Experimental: 1
    Arm 1: Montelukast
    Interventions:
    • Drug: montelukast sodium
    • Drug: Comparator: Placebo
  • Active Comparator: 2
    Arm 2: Fluticasone
    Interventions:
    • Drug: Comparator: fluticasone
    • Drug: Comparator: Placebo
  • Placebo Comparator: 3
    Arm 3: Placebo
    Interventions:
    • Drug: Comparator: Placebo
    • Drug: Comparator: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1640
April 2010
April 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Austria,   Belgium,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Ecuador,   Egypt,   Estonia,   Finland,   Greece,   Hungary,   India,   Israel,   Korea, Republic of,   Lebanon,   Lithuania,   Malaysia,   Mexico,   Peru,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Slovenia,   South Africa,   Spain,   Turkey,   United Arab Emirates
 
NCT00284856
0476-332
2005_108
No
Not Provided
Plan to Share IPD: Yes
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

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP