Trial Outcomes & Findings for Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds (NCT NCT00189475)

NCT ID: NCT00189475

Last Updated: 2020-11-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 84 participants
• Primary outcome timeframe: 6 days after naturally acquiring an upper respiratory infection
• Results posted on: 2020-11-18

Participant Flow

Participant milestones

Measure	Montelukast Treated for 4 months with montelukast 4 mg per day Montelukast	Placebo Treated for 4 months with placebo
Overall Study STARTED	42	42
Overall Study COMPLETED	42	42
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluate the Potential of Montelukast to Prevent Nasal Symptomatology During Colds

Baseline characteristics by cohort

Measure	Montelukast n=42 Participants Treated for 4 months with montelukast 4 mg per day Montelukast	Placebo n=42 Participants Treated for 4 months with placebo	Total n=84 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
Age, Categorical Between 18 and 65 years	42 Participants n=5 Participants	42 Participants n=7 Participants	84 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex/Gender, Customized Male	13 participants n=5 Participants	13 participants n=7 Participants	26 participants n=5 Participants
Sex/Gender, Customized Female	29 participants n=5 Participants	29 participants n=7 Participants	58 participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants	42 participants n=7 Participants	84 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 days after naturally acquiring an upper respiratory infection

Outcome measures

Measure	Montelukast n=42 Participants Montelukast 10mg per day for 6 days	Placebo n=42 Participants Treated for 6 days with placebo
Nasal Secretion Weights Day 1	3.5 grams Standard Error 0.4	4.2 grams Standard Error 0.6
Nasal Secretion Weights Day 6	1.2 grams Standard Error 0.4	2.6 grams Standard Error 0.4

Adverse Events

Montelukast

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Skoner, MD

Allegheny Singer Research Institute, WPAHS

Phone: 4123594099

Email: dskoner@wpahs.org

Results disclosure agreements

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