Role of Montelukast in Asthma and Allergic Rhinitis Patients

Asthma and Allergic Rhinitis Clinical Trial

— MAAP  

Official title:

Role of Montelukast in Asthma and Allergic Rhinitis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03380975
• Other study ID #: CN/PK/MAAP/SP/2017-01
• Status: Completed
• Phase: Phase 4
• Start date: August 28, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: December 2017
• Source: Clinision
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: June 30, 2019
• Est. primary completion date: March 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma and Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

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

Locations

Country	Name	City	State
Pakistan	Dr. Faisal Faiyaz Zuberi	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Clinision

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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]	4 weeks
Secondary	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]	4 weeks
Secondary	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]	4 weeks