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Completed

NCT Number: NCT03380975

Role of Montelukast in Asthma and Allergic Rhinitis Patients

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

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Key information

Conditions

Asthma and Allergic Rhinitis Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dr. Faisal Faiyaz Zuberi

Karachi, Sindh, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Aireez

Primary outcomes

  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 outcomes

  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]

Sponsors and collaborators

Lead sponsor

Clinision

Other

Registry information

Acronym: MAAP

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 21, 2017
Registry last updated
Jan 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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