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

Clinision

Status and phase: Completed; Phase 4

Conditions: Asthma and Allergic Rhinitis

Treatments: Drug: Montelukast 10mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03380975

CN/PK/MAAP/SP/2017-01

Details and patient eligibility

About

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

Full 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

Enrollment: 600 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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600 participants in 1 patient group

Montelukast 10 mg

Experimental group

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.

Treatment:

Drug: Montelukast 10mg