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

• ClinicalTrials.gov Identifier: NCT03380975
• Recruitment Status: Completed
• First Posted: December 21, 2017
• Last Update Posted: January 3, 2020
• Sponsor: Clinision
• Information provided by (Responsible Party): Clinision

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Asthma and Allergic Rhinitis	Drug: Montelukast 10mg	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 600 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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
• Primary Purpose: Treatment
• Official Title: Role of Montelukast in Asthma and Allergic Rhinitis Patients
• Actual Study Start Date: August 28, 2018
• Actual Primary Completion Date: March 25, 2019
• Actual Study Completion Date: June 30, 2019

Arms and Interventions

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 Name: Aireez

Outcome Measures

Primary Outcome Measures :

1. 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]

Secondary Outcome Measures :

1. 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]
2. 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]
3. 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]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Pakistan

Dr. Faisal Faiyaz Zuberi

Karachi, Sindh, Pakistan

Sponsors and Collaborators

Clinision

Investigators

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

More Information

• Responsible Party: Clinision
• ClinicalTrials.gov Identifier: NCT03380975
• Other Study ID Numbers: CN/PK/MAAP/SP/2017-01
• First Posted: December 21, 2017
• Last Update Posted: January 3, 2020
• Last Verified: December 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Clinision:

MAAP; Asthma; Allergic rhinits

Additional relevant MeSH terms:

Asthma; Rhinitis; Rhinitis, Allergic; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nose Diseases; Respiratory Tract Infections; Otorhinolaryngologic Diseases; Montelukast; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Molecular Mechanisms of Pharmacological Action