TEAM (Trial on Efficacy and Quality of Life Among Asthmatic Patient With Montelukast)

NCT03096327 | Completed Phase 4 DMC

• 1 other identifier: PE/PK/TEAM/IIT/2017-01
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

• To compare the quality of Life using AQLQ (s) questionnaire after 4 weeks of Montelukast.

Conditions

Asthma

Keywords

Quality of Life; Asthma control test; Montelukast; Asthma

Outcome Measures

Primary Outcomes (1)

• To assess the change in quality of Life using AQLQ (s) questionnaire after 4 weeks of Montelukast.

  \[Designated as safety issue: No\]

  0 days to 4 weeks

Secondary Outcomes (2)

• To assess the change in Control of Asthma using AQLQ (s) questionnaire after 4 weeks of Montelukast.

  0 days to 4 weeks

• Proportion of participants experiencing an adverse event (AE)

  0 days to 4 weeks

Study Arms (2)

Intervention (Montelukast)

EXPERIMENTAL

Aireez contains Montelukast which is a potent and selective blocker of the CysLT1 receptor. For treatment of chronic 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.

Drug: Montelukast

Placebo

PLACEBO COMPARATOR

Patients in placebo group will receive identical looking drug (placebo) produced by same manufactured.

Drug: Placebo

Interventions

Montelukast DRUG

Montelukast sodium is a selective blocker of the CysLT1 receptor. For treatment of chronic 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.

Also known as: TEAM

Intervention (Montelukast)

Placebo DRUG

Patients in placebo group will receive identical looking drug (placebo) produced by same manufactured

Also known as: TEAM

Placebo

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Asthma
• Signed Informed Consent

You may not qualify if:

• Previous adverse reaction to montelukast or other leukotriene inhibitor;
• History of hyper-eosinophilic disorder other than atopic disease;
• Treatment with montelukast within 4 weeks from randomization;
• Asthma exacerbation or treatment with prednisone/other systemic steroid within 4 weeks from randomization.

Sponsors & Collaborators

• PharmEvo Pvt Ltd: lead

Study Sites (1)

Dr. Nadeem Rizvi

Karachi, Sindh, 75510, Pakistan

Location

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Masood Jawaid, MRCS,FCPS

  PharmEvo Pvt Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: To ensure double-blind allocation, the sponsor, who is not directly involved in clinical team will use a random number sequence generated by a computer software to allocate the participant to either the treatment or placebo group. Patients who will be randomized to the treatment group will receive 10 mg montelukast. Patients in placebo group will receive identical looking drug (placebo) produced by same manufactured. Both products will be packaged in identical plastic bottles identifiable only by the patient allocation number. Patient will be asked to take one montelukast each day. Acceptable compliance will be defined as at least taking medication at least 21 days. The patients will be instructed to leave the remaining tablets in bottle so that they would be counted later.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Two arm Parallel Assignment Masking: Double Blind Primary Purpose: Prevention

Study Record Dates

• First Submitted: March 17, 2017
• First Posted: March 30, 2017
• Study Start: May 1, 2017
• Primary Completion: December 30, 2017
• Study Completion: May 30, 2018
• Last Updated: July 9, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)