Role of Montelukast in Asthma and Allergic Rhinitis Patients (MAAP)
Primary Purpose
Asthma and Allergic Rhinitis
Status
Completed
Phase
Phase 4
Locations
Pakistan
Study Type
Interventional
Intervention
Montelukast 10mg
Sponsored by
About this trial
This is an interventional treatment trial for Asthma and Allergic Rhinitis focused on measuring MAAP, Asthma, Allergic rhinits
Eligibility Criteria
Inclusion Criteria:
- Age >18 years
- Signed Informed Consent
- Clinical diagnosis of Asthma and Allergic Rhinitis
Exclusion Criteria:
- Previous adverse reaction to Montelukast
- History of hyper-eosinophilic disorder other than atopic disease
- Female subjects who are pregnant, breast-feeding
- Any significant and active pulmonary pathology other than asthma
Sites / Locations
- Dr. Faisal Faiyaz Zuberi
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Montelukast 10 mg
Arm Description
Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor. Montelukast inhibits physiologic actions of LTD4 at the CysLT1 receptor without any agonist activity. As a result, bronchoconstriction is inhibited with decreased airway and blood eosinophil's leading to improved control over asthma and allergic rhinitis.
Outcomes
Primary Outcome Measures
Efficacy of montelukast on asthma day and night symptoms changes from baseline after 4 weeks of treatment
To determine the efficacy of montelukast on asthma day and night symptoms changes from baseline after 4 weeks of treatment [Designated as safety issue: No] [Time Frame: 0 days to 4 weeks]
Secondary Outcome Measures
Efficacy of montelukast on allergic rhinitis symptoms changes from baseline after 4 weeks of treatment
To determine the efficacy of montelukast on allergic rhinitis symptoms changes from baseline after 4 weeks of treatment [Designated as safety issue: No] [Time Frame: 0 days to 4 weeks]
Effect of montelukast in change in individual quality of life using Quality of life questionnaire after 4 weeks of treatment
To determine the effect of montelukast in change in individual quality of life using Quality of life questionnaire after 4 weeks of treatment [Designated as safety issue: No] [Time Frame: 0 days to 4 weeks]
Proportion of participants experiencing an adverse event (AE)
Proportion of participants experiencing an adverse event (AE) [Designated as safety issue: Yes] [Time Frame: 0 days to 4 weeks]
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03380975
Brief Title
Role of Montelukast in Asthma and Allergic Rhinitis Patients
Acronym
MAAP
Official Title
Role of Montelukast in Asthma and Allergic Rhinitis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
August 28, 2018 (Actual)
Primary Completion Date
March 25, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinision
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To determine the effect of Montelukast in Asthma and Allergic rhinits patients
Detailed Description
Montelukast is a potent and selective blocker of the CysLT1 receptor. Accordingly, a recent study has shown that Montelukast can improve symptoms of seasonal allergic rhinitis and asthma in patients with both diseases. For treatment of asthma, Montelukast is administered once daily to adults as a 10-mg film-coated tablet, to children aged 6-14 years as a 5-mg chewable tablet, and to children aged 2-5 years as a 4-mg chewable tablet form. Asthma and allergic rhinitis have been linked clinically for many years as "one airway one diseases". Patients with allergic asthma and rhinitis are significantly more likely to experience asthma attacks compared to patients with asthma alone. Side effects most commonly reported above placebo included headache, otitis media, upper respiratory infection, and pharyngitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma and Allergic Rhinitis
Keywords
MAAP, Asthma, Allergic rhinits
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor. Montelukast inhibits physiologic actions of LTD4 at the CysLT1 receptor without any agonist activity. As a result, bronchoconstriction is inhibited with decreased airway and blood eosinophil's leading to improved control over asthma and allergic rhinitis
Masking
None (Open Label)
Masking Description
Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor.Montelukast should be taken once daily in the evening
Allocation
N/A
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Montelukast 10 mg
Arm Type
Experimental
Arm Description
Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor. Montelukast inhibits physiologic actions of LTD4 at the CysLT1 receptor without any agonist activity. As a result, bronchoconstriction is inhibited with decreased airway and blood eosinophil's leading to improved control over asthma and allergic rhinitis.
Intervention Type
Drug
Intervention Name(s)
Montelukast 10mg
Other Intervention Name(s)
Aireez
Intervention Description
Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor. Montelukast inhibits physiologic actions of LTD4 at the CysLT1 receptor without any agonist activity. As a result, bronchoconstriction is inhibited with decreased airway and blood eosinophil's leading to improved control over asthma and allergic rhinitis. Montelukast should be taken once daily in the evening
Primary Outcome Measure Information:
Title
Efficacy of montelukast on asthma day and night symptoms changes from baseline after 4 weeks of treatment
Description
To determine the efficacy of montelukast on asthma day and night symptoms changes from baseline after 4 weeks of treatment [Designated as safety issue: No] [Time Frame: 0 days to 4 weeks]
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Efficacy of montelukast on allergic rhinitis symptoms changes from baseline after 4 weeks of treatment
Description
To determine the efficacy of montelukast on allergic rhinitis symptoms changes from baseline after 4 weeks of treatment [Designated as safety issue: No] [Time Frame: 0 days to 4 weeks]
Time Frame
4 weeks
Title
Effect of montelukast in change in individual quality of life using Quality of life questionnaire after 4 weeks of treatment
Description
To determine the effect of montelukast in change in individual quality of life using Quality of life questionnaire after 4 weeks of treatment [Designated as safety issue: No] [Time Frame: 0 days to 4 weeks]
Time Frame
4 weeks
Title
Proportion of participants experiencing an adverse event (AE)
Description
Proportion of participants experiencing an adverse event (AE) [Designated as safety issue: Yes] [Time Frame: 0 days to 4 weeks]
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >18 years
Signed Informed Consent
Clinical diagnosis of Asthma and Allergic Rhinitis
Exclusion Criteria:
Previous adverse reaction to Montelukast
History of hyper-eosinophilic disorder other than atopic disease
Female subjects who are pregnant, breast-feeding
Any significant and active pulmonary pathology other than asthma
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faisal Faiyaz, FCPS,FCPS
Organizational Affiliation
Dow University of Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Faisal Faiyaz Zuberi
City
Karachi
State/Province
Sindh
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Role of Montelukast in Asthma and Allergic Rhinitis Patients
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