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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03380975
Recruitment Status : Completed
First Posted : December 21, 2017
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Clinision

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Montelukast

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




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]



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380975


Locations
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Pakistan
Dr. Faisal Faiyaz Zuberi
Karachi, Sindh, Pakistan
Sponsors and Collaborators
Clinision
Investigators
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Principal Investigator: Faisal Faiyaz, FCPS,FCPS Dow University of Health Sciences

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

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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:
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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