Role of Montelukast in Asthma and Allergic Rhinitis Patients

NCT03380975 | Completed Phase 4

• 1 other identifier: CN/PK/MAAP/SP/2017-01
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effect of Montelukast in Asthma and Allergic rhinits patients

Conditions

Asthma and Allergic Rhinitis

Keywords

MAAP; Asthma; Allergic rhinits

Outcome Measures

Primary Outcomes (1)

• 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 \[Designated as safety issue: No\] \[Time Frame: 0 days to 4 weeks\]

  4 weeks

Secondary Outcomes (3)

• Efficacy of montelukast on allergic rhinitis symptoms changes from baseline after 4 weeks of treatment

  4 weeks

• Effect of montelukast in change in individual quality of life using Quality of life questionnaire after 4 weeks of treatment

  4 weeks

• Proportion of participants experiencing an adverse event (AE)

  4 weeks

Study Arms (1)

Montelukast 10 mg

EXPERIMENTAL

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

Interventions

Montelukast 10mg DRUG

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

Also known as: Aireez

Montelukast 10 mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Signed Informed Consent
• Clinical diagnosis of Asthma and Allergic Rhinitis

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinision: lead

Study Sites (1)

Dr. Faisal Faiyaz Zuberi

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Asthma; Rhinitis, Allergic

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases

Study Officials

• Faisal Faiyaz, FCPS,FCPS

  Dow University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 21, 2017
• Study Start: August 28, 2018
• Primary Completion: March 25, 2019
• Study Completion: June 30, 2019
• Last Updated: January 3, 2020

Record last verified: 2017-12

Locations

PA (1)