Trial Outcomes & Findings for The Effects of Montelukast on Smokers With Asthma (NCT NCT00712335)

Results Overview

Week 24 sputum neutrophil percentages were measured in active treatment groups.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

105 participants

Primary outcome timeframe

24 weeks

Results posted on

2012-05-16

Participant Flow

Recruitment period: January 2008-April 2011 Recruitment location: Asthma and Allergy Center, Inje University Sanggye Paik Hospital

After randomization, a 10-day washout period followed in which subjects were taken off all medications except albuterol metered dose inhaler as needed. After the washout period, baseline induced sputum was obtained in each group along with primary and secondary endpoints. This was followed by a 3-week run in period.

Participant milestones

Participant milestones
Measure	Asthmatic Smokers Treated With Combination Therapy Asthmatic smokers treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months	Asthmatic Smoker Treated With Montelukast Only Asthmatic smoker treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months	Non-smoking Asthmatic Treated With Combination Therapy Non-smoking asthmatic treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months	Non-smoking Asthmatic Treated With Montelukast Only Non-smoking asthmatic treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months	Normal Controls Normal controls did not receive any treatment.
Overall Study STARTED	8	32	11	24	30
Overall Study COMPLETED	5	15	6	19	30
Overall Study NOT COMPLETED	3	17	5	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Asthmatic Smokers Treated With Combination Therapy Asthmatic smokers treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months	Asthmatic Smoker Treated With Montelukast Only Asthmatic smoker treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months	Non-smoking Asthmatic Treated With Combination Therapy Non-smoking asthmatic treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months	Non-smoking Asthmatic Treated With Montelukast Only Non-smoking asthmatic treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months
Overall Study Withdrawal by Subject	0	7	2	3
Overall Study Lost to Follow-up	2	5	0	1
Overall Study Protocol Violation	1	2	1	0
Overall Study Lack of Efficacy	0	0	1	1
Overall Study Other Reason	0	3	1	0

Baseline Characteristics

The Effects of Montelukast on Smokers With Asthma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Asthmatic Smokers Treated With Combination Therapy n=8 Participants Asthmatic smokers treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months	Asthmatic Smoker Treated With Montelukast Only n=32 Participants Asthmatic smoker treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months	Non-smoking Asthmatic Treated With Combination Therapy n=11 Participants Non-smoking asthmatic treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months	Non-smoking Asthmatic Treated With Montelukast Only n=24 Participants Non-smoking asthmatic treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months	Normal Controls n=30 Participants Normal controls did not receive any treatment.	Total n=105 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	32 Participants n=7 Participants	11 Participants n=5 Participants	24 Participants n=4 Participants	30 Participants n=21 Participants	105 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age Continuous	51.38 years STANDARD_DEVIATION 11.41 • n=5 Participants	36.03 years STANDARD_DEVIATION 8.52 • n=7 Participants	45.64 years STANDARD_DEVIATION 17.46 • n=5 Participants	39.00 years STANDARD_DEVIATION 14.79 • n=4 Participants	40.55 years STANDARD_DEVIATION 11.35 • n=21 Participants	40.09 years STANDARD_DEVIATION 4.24 • n=8 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	22 Participants n=4 Participants	22 Participants n=21 Participants	56 Participants n=8 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	27 Participants n=7 Participants	7 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants	49 Participants n=8 Participants
Region of Enrollment Korea, Republic of	8 participants n=5 Participants	32 participants n=7 Participants	11 participants n=5 Participants	24 participants n=4 Participants	30 participants n=21 Participants	105 participants n=8 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: We will be using intention-to-treat and per protocol for analysis.

Week 24 sputum neutrophil percentages were measured in active treatment groups.

Outcome measures

Outcome measures
Measure	Asthmatic Smokers Treated With Combination Therapy n=5 Participants Asthmatic smokers treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months	Asthmatic Smoker Treated With Montelukast Only n=15 Participants Asthmatic smoker treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months	Non-smoking Asthmatic Treated With Combination Therapy n=6 Participants Non-smoking asthmatic treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months	Non-smoking Asthmatic Treated With Montelukast Only n=19 Participants Non-smoking asthmatic treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months	Normal Controls Normal controls did not receive any treatment.
Sputum Neutrophil Percentages	86.00 percentage of neutrophils Standard Deviation 8.22	72.53 percentage of neutrophils Standard Deviation 24.14	89.33 percentage of neutrophils Standard Deviation 6.41	79.84 percentage of neutrophils Standard Deviation 17.07	—

SECONDARY outcome

Timeframe: 24 weeks

Population: We will use ITT and PP protocols for analysis

Secondary endpoints of inflammatory markers (sputum eosinophil percentages at 24 weeks) were measured in active treatment groups

Outcome measures

Outcome measures
Measure	Asthmatic Smokers Treated With Combination Therapy n=5 Participants Asthmatic smokers treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months	Asthmatic Smoker Treated With Montelukast Only n=15 Participants Asthmatic smoker treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months	Non-smoking Asthmatic Treated With Combination Therapy n=6 Participants Non-smoking asthmatic treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months	Non-smoking Asthmatic Treated With Montelukast Only n=19 Participants Non-smoking asthmatic treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months	Normal Controls Normal controls did not receive any treatment.
Sputum Eosinophil Percentages	2.33 percentage of eosinophils Standard Deviation 3.01	3.60 percentage of eosinophils Standard Deviation 6.43	1.60 percentage of eosinophils Standard Deviation 1.34	3.26 percentage of eosinophils Standard Deviation 6.10	—

SECONDARY outcome

Timeframe: 24 weeks

Population: We will ITT and PP protocols for analysis

Week 24 sputum IL-8 levels in active treatment groups

Outcome measures

Outcome measures
Measure	Asthmatic Smokers Treated With Combination Therapy n=5 Participants Asthmatic smokers treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months	Asthmatic Smoker Treated With Montelukast Only n=15 Participants Asthmatic smoker treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months	Non-smoking Asthmatic Treated With Combination Therapy n=6 Participants Non-smoking asthmatic treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months	Non-smoking Asthmatic Treated With Montelukast Only n=19 Participants Non-smoking asthmatic treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months	Normal Controls Normal controls did not receive any treatment.
Sputum IL-8 Levels	334545 pg/ml Standard Deviation 804,831	26,300 pg/ml Standard Deviation 74,106	3602 pg/ml Standard Deviation 2342	317778 pg/ml Standard Deviation 738415	—

SECONDARY outcome

Timeframe: 24 weeks

Population: We will use ITT and PP for analysis

Week 24 sputum GM-CSF levels in active treatment groups were measured.

Outcome measures

Outcome measures
Measure	Asthmatic Smokers Treated With Combination Therapy n=5 Participants Asthmatic smokers treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months	Asthmatic Smoker Treated With Montelukast Only n=15 Participants Asthmatic smoker treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months	Non-smoking Asthmatic Treated With Combination Therapy n=6 Participants Non-smoking asthmatic treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months	Non-smoking Asthmatic Treated With Montelukast Only n=19 Participants Non-smoking asthmatic treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months	Normal Controls Normal controls did not receive any treatment.
Sputum GM-CSF Levels	17.60 pg/ml Standard Deviation 24.67	15.18 pg/ml Standard Deviation 16.37	13.92 pg/ml Standard Deviation 10.66	12.16 pg/ml Standard Deviation 18.05	—

SECONDARY outcome

Timeframe: 24 weeks

Population: ITT and PP were used for analysis.

Week 24 sputum IFN-gamma/IL-5 ratios were determined in active treatment groups.

Outcome measures

Outcome measures
Measure	Asthmatic Smokers Treated With Combination Therapy n=5 Participants Asthmatic smokers treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months	Asthmatic Smoker Treated With Montelukast Only n=15 Participants Asthmatic smoker treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months	Non-smoking Asthmatic Treated With Combination Therapy n=6 Participants Non-smoking asthmatic treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months	Non-smoking Asthmatic Treated With Montelukast Only n=19 Participants Non-smoking asthmatic treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months	Normal Controls Normal controls did not receive any treatment.
Sputum IFN-gamma/IL-5 Ratios	627.4 ratio Standard Deviation 742.1	272.4 ratio Standard Deviation 387.1	183.8 ratio Standard Deviation 82.70	279.0 ratio Standard Deviation 563.3	—

SECONDARY outcome

Timeframe: 24 weeks

Population: ITT and PP were used for analysis.

Week 24 sputum eotaxin levels in active treatment groups were measured.

Outcome measures

Outcome measures
Measure	Asthmatic Smokers Treated With Combination Therapy n=5 Participants Asthmatic smokers treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months	Asthmatic Smoker Treated With Montelukast Only n=15 Participants Asthmatic smoker treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months	Non-smoking Asthmatic Treated With Combination Therapy n=6 Participants Non-smoking asthmatic treated with combination therapy: Fluticasone propionate dosage - DPI 250 mcg BID for 3 months Salmeterol dosage - DPI 50 mcg BID for 3 months	Non-smoking Asthmatic Treated With Montelukast Only n=19 Participants Non-smoking asthmatic treated with Montelukast only: Montelukast dosage - PO 10 mg QHS for 3 months	Normal Controls Normal controls did not receive any treatment.
Sputum Eotaxin Levels	47.13 pg/ml Standard Deviation 41.93	87.90 pg/ml Standard Deviation 93.15	65.14 pg/ml Standard Deviation 25.54	64.61 pg/ml Standard Deviation 44.07	—

SECONDARY outcome

Timeframe: 24 weeks

Population: ITT and PP were used for analysis.

Week 24 sputum RANTES levels in active treatment groups were measured.