Trial Outcomes & Findings for Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma (NCT NCT00359073)

NCT ID: NCT00359073

Last Updated: 2018-03-13

Results Overview

Asthma symptom scores were assessed twice per day with subjects completing a validated daytime diary card before bed and a nocturnal diary card on awakening. Subjects answered 4 questions about their asthma symptoms (0, none of the time; 6, all of the time). Daily score were calculated as the average of the 4 questions and an overall score for the week was assessed as the average of the daily scores. Time frame measurement was Day 7.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: Day 7
• Results posted on: 2018-03-13

Participant Flow

Participant milestones

Measure	Montelukast subjects received study drug montelukast, 10 mg once per day	Placebo subjects received placebo, once per day
Overall Study STARTED	12	13
Overall Study COMPLETED	8	11
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Measure	Montelukast subjects received study drug montelukast, 10 mg once per day	Placebo subjects received placebo, once per day
Overall Study Withdrawal by Subject	1	1
Overall Study Eligibility criteria no longer met	3	0
Overall Study developed RV16 antibody	0	1

Baseline Characteristics

Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma

Baseline characteristics by cohort

Measure	Montelukast n=8 Participants subjects received study drug montelukast, 10 mg once per day	Placebo n=11 Participants subjects received placebo, once per day	Total n=19 Participants Total of all reporting groups
Age, Continuous	20 years STANDARD_DEVIATION 2 • n=5 Participants	21 years STANDARD_DEVIATION 3 • n=7 Participants	20 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	11 participants n=7 Participants	19 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 7

Asthma symptom scores were assessed twice per day with subjects completing a validated daytime diary card before bed and a nocturnal diary card on awakening. Subjects answered 4 questions about their asthma symptoms (0, none of the time; 6, all of the time). Daily score were calculated as the average of the 4 questions and an overall score for the week was assessed as the average of the daily scores. Time frame measurement was Day 7.

Outcome measures

Measure	Montelukast n=8 Participants subjects received study drug montelukast, 10 mg once per day	Placebo n=11 Participants subjects received placebo, once per day
Mean Asthma Symptom Score	2.3 Asthma symptom score Interval 0.0 to 4.9	2.1 Asthma symptom score Interval 0.1 to 4.1

SECONDARY outcome

Timeframe: Baseline and 7 days

Viral shedding was measured in both groups. Viral titers from nasal lavage were calculated after 4 tissue culture tubes containing WI38 cells (human lung diploid cells) were inoculated for each serial 10-fold dilution of samples and incubated while rolling at 33 degrees Celsius for 10 days (measurement for analysis was taken at baseline and 7 days). Tubes were read at baseline and 7 days later. TCID50 was calculated as the concentration that was capable of infecting 50% of the tubes. Viral titers are expressed as TCID50 per milliliter. Time frame measurement was at baseline and 7 days.

Outcome measures

Measure	Montelukast n=8 Participants subjects received study drug montelukast, 10 mg once per day	Placebo n=11 Participants subjects received placebo, once per day
Peak Viral Shedding	2.5 TCID50 per milliliter Interval 2.3 to 4.5	3.5 TCID50 per milliliter Interval 2.5 to 4.5

SECONDARY outcome

Timeframe: 14 days

Sputum was collected from both groups over 14 days after inoculation with the cold virus. Cell counts and differentials were made from sputum samples after treatment with 0.1% dithiothreitol. Eosinophils were counted and are expressed as as percentage of cells (percent of the total number counted) at the 14 day timepoint.

Outcome measures

Measure	Montelukast n=8 Participants subjects received study drug montelukast, 10 mg once per day	Placebo n=11 Participants subjects received placebo, once per day
Sputum Eosinophil Count	0.3 percentage of eosinophils Interval 0.1 to 0.3	2.0 percentage of eosinophils Interval 0.3 to 2.7

Adverse Events

Montelukast

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Montelukast n=8 participants at risk subjects received study drug montelukast, 10 mg once per day	Placebo n=11 participants at risk subjects received placebo, once per day
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	0.00% 0/8 • 1 year	9.1% 1/11 • Number of events 1 • 1 year
General disorders Headache	12.5% 1/8 • Number of events 3 • 1 year	0.00% 0/11 • 1 year

Additional Information

Gina Crisafi

University of Wisconsin Madison

Phone: 608-262-5240

Email: gmc@medicine.wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place