Trial Outcomes & Findings for The Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients (0476-029) (NCT NCT00911547)

Last Updated: 2022-02-03

Results Overview

Mean percent change from baseline in FEV1 in patients with chronic asthma averaged over 16 weeks for the Beclo and MK+ Beclo groups and averaged over last 10 weeks for the Placebo and MK groups

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

642 participants

Primary outcome timeframe

Baseline & over 16 weeks for the Beclomethasone (Beclo) and Montelukast (MK) + Beclo groups and over last 10 weeks for the Placebo and MK groups

Results posted on

2022-02-03

Participant Flow

Patients were recruited at 22 sites in the United States (US) and 48 sites in 16 other countries in North America, Europe, Africa, Australia, and Southeast Asia. Publication incorrectly listed 18 participating countries. Results posting is correct with 17 countries. Prime therapy period: March 1995 to April 1996.

Patients received inhaled beclomethasone (200 μg twice daily) starting at the Prestudy Visit and continuing through the single-blind run-in period. Patients who experienced worsening asthma requiring more than albuterol therapy (inhaled or nebulized) did not qualify for randomization.

Participant milestones

Participant milestones
Measure	Placebo Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.	Montelukast MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.	Beclomethasone MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.	Montelukast+ Beclomethasone MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
Overall Study STARTED	48	201	200	193
Overall Study COMPLETED	37	159	178	177
Overall Study NOT COMPLETED	11	42	22	16

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.	Montelukast MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.	Beclomethasone MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.	Montelukast+ Beclomethasone MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
Overall Study Adverse Event	8	27	11	6
Overall Study Lost to Follow-up	0	0	2	1
Overall Study Protocol Violation	0	5	5	1
Overall Study Withdrawal by Subject	3	10	4	8

Baseline Characteristics

The Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients (0476-029)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=48 Participants Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.	Montelukast n=201 Participants MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.	Beclomethasone n=200 Participants MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.	Montelukast+ Beclomethasone n=193 Participants MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.	Total n=642 Participants Total of all reporting groups
Sex: Female, Male Female	29 Participants n=5 Participants	102 Participants n=7 Participants	96 Participants n=5 Participants	85 Participants n=4 Participants	312 Participants n=21 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	99 Participants n=7 Participants	104 Participants n=5 Participants	108 Participants n=4 Participants	330 Participants n=21 Participants
Race/Ethnicity Caucasian	40 participants n=5 Participants	189 participants n=7 Participants	184 participants n=5 Participants	177 participants n=4 Participants	590 participants n=21 Participants
Race/Ethnicity Black	4 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants	5 participants n=4 Participants	16 participants n=21 Participants
Age, Continuous	40.50 years n=5 Participants	38.00 years n=7 Participants	39.00 years n=5 Participants	40.00 years n=4 Participants	39.00 years n=21 Participants
Race/Ethnicity Hispanic	2 participants n=5 Participants	5 participants n=7 Participants	1 participants n=5 Participants	6 participants n=4 Participants	14 participants n=21 Participants
Race/Ethnicity Other	2 participants n=5 Participants	4 participants n=7 Participants	11 participants n=5 Participants	5 participants n=4 Participants	22 participants n=21 Participants
Daytime symptom score	2.36 Units on a Scale STANDARD_DEVIATION 0.68 • n=5 Participants	2.14 Units on a Scale STANDARD_DEVIATION 0.83 • n=7 Participants	2.17 Units on a Scale STANDARD_DEVIATION 0.82 • n=5 Participants	2.17 Units on a Scale STANDARD_DEVIATION 0.84 • n=4 Participants	2.18 Units on a Scale STANDARD_DEVIATION 0.82 • n=21 Participants
Forced expiratory volume in 1 second (FEV1)	2.45 Liters STANDARD_DEVIATION 0.69 • n=5 Participants	2.61 Liters STANDARD_DEVIATION 0.74 • n=7 Participants	2.53 Liters STANDARD_DEVIATION 0.68 • n=5 Participants	2.61 Liters STANDARD_DEVIATION 0.68 • n=4 Participants	2.57 Liters STANDARD_DEVIATION 0.70 • n=21 Participants
Morning peak flow rate (PEFR)	406.80 Liters/minute STANDARD_DEVIATION 73.47 • n=5 Participants	419.94 Liters/minute STANDARD_DEVIATION 92.47 • n=7 Participants	402.91 Liters/minute STANDARD_DEVIATION 86.19 • n=5 Participants	412.46 Liters/minute STANDARD_DEVIATION 91.15 • n=4 Participants	411.42 Liters/minute STANDARD_DEVIATION 88.92 • n=21 Participants
Nocturnal asthma score	0.57 Units on a Scale STANDARD_DEVIATION 0.46 • n=5 Participants	0.41 Units on a Scale STANDARD_DEVIATION 0.45 • n=7 Participants	0.35 Units on a Scale STANDARD_DEVIATION 0.44 • n=5 Participants	0.43 Units on a Scale STANDARD_DEVIATION 0.47 • n=4 Participants	0.41 Units on a Scale STANDARD_DEVIATION 0.46 • n=21 Participants
Total daily Beta-agonist use	4.16 Puffs STANDARD_DEVIATION 3.02 • n=5 Participants	3.52 Puffs STANDARD_DEVIATION 2.34 • n=7 Participants	3.51 Puffs STANDARD_DEVIATION 2.47 • n=5 Participants	3.41 Puffs STANDARD_DEVIATION 2.17 • n=4 Participants	3.53 Puffs STANDARD_DEVIATION 2.39 • n=21 Participants

PRIMARY outcome

Timeframe: Baseline & over 16 weeks for the Beclomethasone (Beclo) and Montelukast (MK) + Beclo groups and over last 10 weeks for the Placebo and MK groups

Population: Primary efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values were imputed. Data collected during discontinuation and unscheduled visits were included the analysis. Differences between treatments are evaluated based on LS means

Mean percent change from baseline in FEV1 in patients with chronic asthma averaged over 16 weeks for the Beclo and MK+ Beclo groups and averaged over last 10 weeks for the Placebo and MK groups

Outcome measures

Outcome measures
Measure	Placebo n=44 Participants Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.	Montelukast n=183 Participants MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.	Beclomethasone n=198 Participants MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.	Montelukast+ Beclomethasone n=191 Participants MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma	-11.96 Percentage of Change Interval -16.28 to -7.64	-5.31 Percentage of Change Interval -7.32 to -3.3	0.72 Percentage of Change Interval -0.89 to 2.33	5.08 Percentage of Change Interval 3.43 to 6.74

PRIMARY outcome

Timeframe: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups

Population: Primary efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis.

The daily daytime symptom score was determined by averaging the daily scores (the patient scored his/her symptoms \[from 0 (best) to 6 (worst)\] on a daily basis.) for the four questions on the Daytime Asthma Symptoms Diary. The average daytime symptom score for the visit was determined by averaging the daily symptom scores over all days between two consecutive visits.

Outcome measures

Outcome measures
Measure	Placebo n=44 Participants Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.	Montelukast n=183 Participants MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.	Beclomethasone n=198 Participants MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.	Montelukast+ Beclomethasone n=191 Participants MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma	0.31 Units on a Scale Interval 0.08 to 0.54	0.27 Units on a Scale Interval 0.17 to 0.38	-0.02 Units on a Scale Interval -0.1 to 0.06	-0.13 Units on a Scale Interval -0.22 to -0.05

SECONDARY outcome

Timeframe: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups

Population: Efficacy analyses were based on the intention-to-treat principle, i.e., inclusion of all patients with a baseline and at least one postbaseline measurement. No missing values for this analysis were imputed. Data collected during discontinuation visits and unscheduled visits were included in this analysis.

Beta-agonist medication use from the daytime and overnight asthma symptoms diaries for each 24-hour period was added to determine the daily total number of puffs used. The average daily number of puffs for the visit was determined as the average daily number of puffs over all days between consecutive visits.

Outcome measures

Outcome measures
Measure	Placebo n=44 Participants Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.	Montelukast n=180 Participants MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.	Beclomethasone n=194 Participants MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.	Montelukast+ Beclomethasone n=189 Participants MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use	59.20 Percent Change Interval 25.77 to 92.63	44.48 Percent Change Interval 28.82 to 60.14	6.04 Percent Change Interval -3.78 to 15.86	-5.51 Percent Change Interval -15.54 to 4.52

SECONDARY outcome

Timeframe: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups

Morning PEFR was measured in triplicate immediately upon arising before taking any medication and the best value recorded on the overnight asthma symptoms diary. The mean morning PEFR for the visit was determined by averaging all valid PEFR measurements for the days between consecutive visits.

Outcome measures

Outcome measures
Measure	Placebo n=44 Participants Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.	Montelukast n=184 Participants MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.	Beclomethasone n=197 Participants MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.	Montelukast+ Beclomethasone n=191 Participants MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
Mean Change From Baseline in Morning Peak Flow Rate (PEFR) in Patients With Chronic Asthma	-27.10 Liters/minute Interval -38.96 to -15.25	-15.37 Liters/minute Interval -20.87 to -9.87	2.65 Liters/minute Interval -1.31 to 6.6	10.41 Liters/minute Interval 6.36 to 14.47

SECONDARY outcome

Timeframe: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups

Mean change from baseline in Nocturnal asthma score; the patient scored his/her symptoms \[from 0 (best) to 3 (worst)\] on a daily basis. Responses to the question, "Did you wake up with asthma symptoms?" (no, once, more than once, awake "all night"), were assigned numerical values (0, 1, 2, 3, respectively). The average score for the visit was determined by averaging the daily scores over all days between consecutive visits.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.	Montelukast n=84 Participants MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.	Beclomethasone n=74 Participants MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.	Montelukast+ Beclomethasone n=85 Participants MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
Mean Change From Baseline in Nocturnal Asthma Score on the Overnight Asthma Symptoms Diary in Nocturnal Asthmatic Patients Only	0.17 Units on a Scale Interval -0.01 to 0.35	0.18 Units on a Scale Interval 0.09 to 0.28	-0.06 Units on a Scale Interval -0.14 to 0.02	-0.20 Units on a Scale Interval -0.28 to -0.12

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 36 other events

Deaths: 0 deaths

Montelukast

Serious events: 4 serious events

Other events: 150 other events

Deaths: 0 deaths

Beclomethasone

Serious events: 6 serious events

Other events: 139 other events

Deaths: 0 deaths

Montelukast+ Beclomethasone

Serious events: 1 serious events

Other events: 123 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=48 participants at risk Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.	Montelukast n=201 participants at risk MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.	Beclomethasone n=200 participants at risk MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.	Montelukast+ Beclomethasone n=193 participants at risk MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
Injury, poisoning and procedural complications Fracture, Ankle	0.00% 0/48 • Over 16 weeks of treatment and for 14 days post-treatment	0.00% 0/201 • Over 16 weeks of treatment and for 14 days post-treatment	0.50% 1/200 • Over 16 weeks of treatment and for 14 days post-treatment	0.00% 0/193 • Over 16 weeks of treatment and for 14 days post-treatment
Musculoskeletal and connective tissue disorders Pain, Back	0.00% 0/48 • Over 16 weeks of treatment and for 14 days post-treatment	0.00% 0/201 • Over 16 weeks of treatment and for 14 days post-treatment	0.00% 0/200 • Over 16 weeks of treatment and for 14 days post-treatment	0.52% 1/193 • Over 16 weeks of treatment and for 14 days post-treatment
Nervous system disorders Neurological Disorder	0.00% 0/48 • Over 16 weeks of treatment and for 14 days post-treatment	0.00% 0/201 • Over 16 weeks of treatment and for 14 days post-treatment	0.50% 1/200 • Over 16 weeks of treatment and for 14 days post-treatment	0.00% 0/193 • Over 16 weeks of treatment and for 14 days post-treatment
Respiratory, thoracic and mediastinal disorders Asthma	2.1% 1/48 • Over 16 weeks of treatment and for 14 days post-treatment	2.0% 4/201 • Over 16 weeks of treatment and for 14 days post-treatment	1.0% 2/200 • Over 16 weeks of treatment and for 14 days post-treatment	0.00% 0/193 • Over 16 weeks of treatment and for 14 days post-treatment
Surgical and medical procedures Surgery, Nasopharyngeal	0.00% 0/48 • Over 16 weeks of treatment and for 14 days post-treatment	0.00% 0/201 • Over 16 weeks of treatment and for 14 days post-treatment	0.50% 1/200 • Over 16 weeks of treatment and for 14 days post-treatment	0.00% 0/193 • Over 16 weeks of treatment and for 14 days post-treatment
Infections and infestations Tonsillitis	0.00% 0/48 • Over 16 weeks of treatment and for 14 days post-treatment	0.00% 0/201 • Over 16 weeks of treatment and for 14 days post-treatment	0.50% 1/200 • Over 16 weeks of treatment and for 14 days post-treatment	0.00% 0/193 • Over 16 weeks of treatment and for 14 days post-treatment
Injury, poisoning and procedural complications Laceration	0.00% 0/48 • Over 16 weeks of treatment and for 14 days post-treatment	0.00% 0/201 • Over 16 weeks of treatment and for 14 days post-treatment	0.50% 1/200 • Over 16 weeks of treatment and for 14 days post-treatment	0.00% 0/193 • Over 16 weeks of treatment and for 14 days post-treatment

Other adverse events

Other adverse events
Measure	Placebo n=48 participants at risk Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.	Montelukast n=201 participants at risk MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.	Beclomethasone n=200 participants at risk MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.	Montelukast+ Beclomethasone n=193 participants at risk MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
Skin and subcutaneous tissue disorders Rash	6.2% 3/48 • Over 16 weeks of treatment and for 14 days post-treatment	3.5% 7/201 • Over 16 weeks of treatment and for 14 days post-treatment	1.5% 3/200 • Over 16 weeks of treatment and for 14 days post-treatment	0.52% 1/193 • Over 16 weeks of treatment and for 14 days post-treatment
General disorders Asthenia/Fatigue	6.2% 3/48 • Over 16 weeks of treatment and for 14 days post-treatment	1.00% 2/201 • Over 16 weeks of treatment and for 14 days post-treatment	0.50% 1/200 • Over 16 weeks of treatment and for 14 days post-treatment	1.6% 3/193 • Over 16 weeks of treatment and for 14 days post-treatment
General disorders Pain, Abdominal	0.00% 0/48 • Over 16 weeks of treatment and for 14 days post-treatment	2.0% 4/201 • Over 16 weeks of treatment and for 14 days post-treatment	3.5% 7/200 • Over 16 weeks of treatment and for 14 days post-treatment	5.2% 10/193 • Over 16 weeks of treatment and for 14 days post-treatment
Gastrointestinal disorders Nausea	0.00% 0/48 • Over 16 weeks of treatment and for 14 days post-treatment	6.0% 12/201 • Over 16 weeks of treatment and for 14 days post-treatment	5.5% 11/200 • Over 16 weeks of treatment and for 14 days post-treatment	2.6% 5/193 • Over 16 weeks of treatment and for 14 days post-treatment
Musculoskeletal and connective tissue disorders Pain, Back	4.2% 2/48 • Over 16 weeks of treatment and for 14 days post-treatment	4.5% 9/201 • Over 16 weeks of treatment and for 14 days post-treatment	3.0% 6/200 • Over 16 weeks of treatment and for 14 days post-treatment	5.2% 10/193 • Over 16 weeks of treatment and for 14 days post-treatment
Nervous system disorders Headache	12.5% 6/48 • Over 16 weeks of treatment and for 14 days post-treatment	25.9% 52/201 • Over 16 weeks of treatment and for 14 days post-treatment	21.0% 42/200 • Over 16 weeks of treatment and for 14 days post-treatment	25.9% 50/193 • Over 16 weeks of treatment and for 14 days post-treatment
Respiratory, thoracic and mediastinal disorders Asthma	41.7% 20/48 • Over 16 weeks of treatment and for 14 days post-treatment	37.3% 75/201 • Over 16 weeks of treatment and for 14 days post-treatment	20.0% 40/200 • Over 16 weeks of treatment and for 14 days post-treatment	11.9% 23/193 • Over 16 weeks of treatment and for 14 days post-treatment
Respiratory, thoracic and mediastinal disorders Bronchitis	8.3% 4/48 • Over 16 weeks of treatment and for 14 days post-treatment	3.5% 7/201 • Over 16 weeks of treatment and for 14 days post-treatment	2.0% 4/200 • Over 16 weeks of treatment and for 14 days post-treatment	2.6% 5/193 • Over 16 weeks of treatment and for 14 days post-treatment
Respiratory, thoracic and mediastinal disorders Cough	6.2% 3/48 • Over 16 weeks of treatment and for 14 days post-treatment	5.5% 11/201 • Over 16 weeks of treatment and for 14 days post-treatment	2.5% 5/200 • Over 16 weeks of treatment and for 14 days post-treatment	4.1% 8/193 • Over 16 weeks of treatment and for 14 days post-treatment
Infections and infestations Infection, Respiratory, Upper	39.6% 19/48 • Over 16 weeks of treatment and for 14 days post-treatment	35.8% 72/201 • Over 16 weeks of treatment and for 14 days post-treatment	39.5% 79/200 • Over 16 weeks of treatment and for 14 days post-treatment	36.3% 70/193 • Over 16 weeks of treatment and for 14 days post-treatment
Infections and infestations Influenza	6.2% 3/48 • Over 16 weeks of treatment and for 14 days post-treatment	7.5% 15/201 • Over 16 weeks of treatment and for 14 days post-treatment	5.5% 11/200 • Over 16 weeks of treatment and for 14 days post-treatment	5.7% 11/193 • Over 16 weeks of treatment and for 14 days post-treatment
Infections and infestations Pharyngitis	4.2% 2/48 • Over 16 weeks of treatment and for 14 days post-treatment	6.0% 12/201 • Over 16 weeks of treatment and for 14 days post-treatment	8.0% 16/200 • Over 16 weeks of treatment and for 14 days post-treatment	5.2% 10/193 • Over 16 weeks of treatment and for 14 days post-treatment
Infections and infestations Sinusitis	4.2% 2/48 • Over 16 weeks of treatment and for 14 days post-treatment	6.0% 12/201 • Over 16 weeks of treatment and for 14 days post-treatment	4.5% 9/200 • Over 16 weeks of treatment and for 14 days post-treatment	4.1% 8/193 • Over 16 weeks of treatment and for 14 days post-treatment

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER