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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
Clinision
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma and Allergic Rhinitis focused on measuring MAAP, Asthma, Allergic rhinits

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 18, 2017
Last Updated
January 2, 2020
Sponsor
Clinision
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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

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Role of Montelukast in Asthma and Allergic Rhinitis Patients

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