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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00284856
• Other study ID #: 0476-332
• Secondary ID: 2005_108
• Status: Completed
• Phase: Phase 3
• Start date: May 2006
• Est. completion date: April 2010

Study information

• Verified date: January 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1640
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• montelukast sodium
montelukast 10 mg tablet once daily, 6 month treatment period
• Comparator: Placebo
fluticasone propionate 250 mcg Placebo (Pbo) twice daily, 6 month treatment period
• Comparator: fluticasone
fluticasone propionate 250 mcg twice daily, 6 month treatment period
• Comparator: Placebo
montelukast 10 mg Pbo tablet once daily, 6 month treatment period

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ß-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), ß-agonist use, asthma attacks and smoking activity.	6 months
Secondary	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.	Baseline and 6 months
Secondary	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.	Baseline and 6 months