Asthma and Allergic Rhinitis
Conditions
Keywords
MAAP, Asthma, Allergic rhinits
Brief summary
To determine the effect of Montelukast in Asthma and Allergic rhinits patients
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
Interventions
DRUGMontelukast 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
Sponsors
Clinision
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of montelukast on asthma day and night symptoms changes from baseline after 4 weeks of treatment | 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
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of montelukast on allergic rhinitis symptoms changes from baseline after 4 weeks of treatment | 4 weeks | To determine the efficacy of montelukast on allergic rhinitis symptoms changes from baseline after 4 weeks of treatment \[Designated as safety issue: No\] \[Time Frame: 0 days to 4 weeks\] |
| Effect of montelukast in change in individual quality of life using Quality of life questionnaire after 4 weeks of treatment | 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 \[Designated as safety issue: No\] \[Time Frame: 0 days to 4 weeks\] |
| Proportion of participants experiencing an adverse event (AE) | 4 weeks | Proportion of participants experiencing an adverse event (AE) \[Designated as safety issue: Yes\] \[Time Frame: 0 days to 4 weeks\] |
Countries
Pakistan
Outcome results
None listed