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Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma

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ClinicalTrials.gov Identifier: NCT00359073
Recruitment Status : Completed
First Posted : August 1, 2006
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Asthma
Interventions Drug: montelukast
Drug: placebo
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Montelukast Placebo
Hide Arm/Group Description subjects received study drug montelukast, 10 mg once per day subjects received placebo, once per day
Period Title: Overall Study
Started 12 13
Completed 8 11
Not Completed 4 2
Reason Not Completed
Withdrawal by Subject             1             1
Eligibility criteria no longer met             3             0
developed RV16 antibody             0             1
Arm/Group Title Montelukast Placebo Total
Hide Arm/Group Description subjects received study drug montelukast, 10 mg once per day subjects received placebo, once per day Total of all reporting groups
Overall Number of Baseline Participants 8 11 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 11 participants 19 participants
20  (2) 21  (3) 20  (4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 11 participants 19 participants
Female
3
  37.5%
4
  36.4%
7
  36.8%
Male
5
  62.5%
7
  63.6%
12
  63.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 11 participants 19 participants
8 11 19
1.Primary Outcome
Title Mean Asthma Symptom Score
Hide Description 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.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Montelukast Placebo
Hide Arm/Group Description:
subjects received study drug montelukast, 10 mg once per day
subjects received placebo, once per day
Overall Number of Participants Analyzed 8 11
Median (Inter-Quartile Range)
Unit of Measure: Asthma symptom score
2.3
(0.0 to 4.9)
2.1
(0.1 to 4.1)
2.Secondary Outcome
Title Peak Viral Shedding
Hide Description 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.
Time Frame Baseline and 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Montelukast Placebo
Hide Arm/Group Description:

montelukast (10 mg everyday)

montelukast: 10 mg everyday

Placebo comparator

placebo: like placebo

Overall Number of Participants Analyzed 8 11
Median (Inter-Quartile Range)
Unit of Measure: TCID50 per milliliter
2.5
(2.3 to 4.5)
3.5
(2.5 to 4.5)
3.Secondary Outcome
Title Sputum Eosinophil Count
Hide Description 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.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Montelukast Placebo
Hide Arm/Group Description:
subjects received study drug montelukast, 10 mg once per day
subjects received placebo, once per day
Overall Number of Participants Analyzed 8 11
Median (Inter-Quartile Range)
Unit of Measure: percentage of eosinophils
0.3
(0.1 to 0.3)
2.0
(0.3 to 2.7)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Montelukast Placebo
Hide Arm/Group Description subjects received study drug montelukast, 10 mg once per day subjects received placebo, once per day
All-Cause Mortality
Montelukast Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/8 (0.00%)      0/11 (0.00%)    
Hide Serious Adverse Events
Montelukast Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/11 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Montelukast Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/8 (12.50%)      1/11 (9.09%)    
General disorders     
Headache *  1/8 (12.50%)  3 0/11 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Upper Respiratory Infection *  0/8 (0.00%)  0 1/11 (9.09%)  1
*
Indicates events were collected by non-systematic assessment
Was a pilot study; small sample size limited statistical power; subgroup analysis not applicable
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gina Crisafi
Organization: University of Wisconsin Madison
Phone: 608-262-5240
EMail: gmc@medicine.wisc.edu
Layout table for additonal information
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00359073    
Other Study ID Numbers: H-2006-0173
31799 ( Other Identifier: PI )
First Submitted: July 28, 2006
First Posted: August 1, 2006
Results First Submitted: August 17, 2010
Results First Posted: March 13, 2018
Last Update Posted: March 13, 2018