Role of Montelukast in Asthma and Allergic Rhinitis Patients (MAAP)

January 2, 2020 updated by: Clinision
To determine the effect of Montelukast in Asthma and Allergic rhinits patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Dr. Faisal Faiyaz Zuberi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Montelukast 10 mg
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.
Drug: Montelukast 10mg
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
Other Names:
  • Aireez

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of montelukast on asthma day and night symptoms changes from baseline after 4 weeks of treatment
Time Frame: 4 weeks
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]
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of montelukast on allergic rhinitis symptoms changes from baseline after 4 weeks of treatment
Time Frame: 4 weeks
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]
4 weeks
Effect of montelukast in change in individual quality of life using Quality of life questionnaire after 4 weeks of treatment
Time Frame: 4 weeks
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]
4 weeks
Proportion of participants experiencing an adverse event (AE)
Time Frame: 4 weeks
Proportion of participants experiencing an adverse event (AE) [Designated as safety issue: Yes] [Time Frame: 0 days to 4 weeks]
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinision

Investigators

  • Principal Investigator: Faisal Faiyaz, FCPS,FCPS, Dow University of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2018

Primary Completion (Actual)

March 25, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

December 18, 2017

First Submitted That Met QC Criteria

December 18, 2017

First Posted (Actual)

December 21, 2017

Study Record Updates

Last Update Posted (Actual)

January 3, 2020

Last Update Submitted That Met QC Criteria

January 2, 2020

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN/PK/MAAP/SP/2017-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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