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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03096327 |
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Date of registration:
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17/03/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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TEAM (Trial on Efficacy and Quality of Life Among Asthmatic Patient With Montelukast)
TEAM |
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Scientific title:
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TEAM (Trial on Efficacy and Quality of Life Among Asthmatic Patient With Montelukast) |
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Date of first enrolment:
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May 1, 2017 |
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Target sample size:
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180 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03096327 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
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Phase:
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Phase 4
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Countries of recruitment
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Pakistan
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Contacts
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Name:
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Masood Jawaid, MRCS,FCPS |
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Address:
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Telephone:
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Email:
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Affiliation:
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PharmEvo Pvt Ltd |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Clinical diagnosis of Asthma
- Signed Informed Consent
Exclusion Criteria:
- Previous adverse reaction to montelukast or other leukotriene inhibitor;
- History of hyper-eosinophilic disorder other than atopic disease;
- Treatment with montelukast within 4 weeks from randomization;
- Asthma exacerbation or treatment with prednisone/other systemic steroid within 4 weeks
from randomization.
Age minimum:
15 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Asthma
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Intervention(s)
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Drug: Placebo
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Drug: Montelukast
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Primary Outcome(s)
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To assess the change in quality of Life using AQLQ (s) questionnaire after 4 weeks of Montelukast.
[Time Frame: 0 days to 4 weeks]
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Secondary Outcome(s)
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Proportion of participants experiencing an adverse event (AE)
[Time Frame: 0 days to 4 weeks]
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To assess the change in Control of Asthma using AQLQ (s) questionnaire after 4 weeks of Montelukast.
[Time Frame: 0 days to 4 weeks]
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Secondary ID(s)
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PE/PK/TEAM/IIT/2017-01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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