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

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Montelukast; Drug: Placebo

Detailed Description

1.1 Background

Asthma is characterized by airway and lung tissue inflammation and airway hyperresponsiveness (AHR) that leads to recurrent symptoms of wheezing, breathlessness, chest tightness, and coughing. AHR indicates an exaggerated response of the airway to nonspecific stimuli, which results in a temporary airflow limitation, leading to airway obstruction. It remains unknown which factors within the airway of an individual trigger reversible airway obstruction and airway narrowing. The airway epithelium is composed of many interacting structural components and inflammatory cells. The number, activation, and secretory component of inflammatory cells in the airway are altered in the disease. In asthma, the number of eosinophils and T lymphocytes is increased in the subepithelial layer.

The impact of asthma has traditionally been measured in terms of the prevalence of the disease, mortality rates, and levels of healthcare utilisation, particularly hospital admissions. However, the impact of asthma extends beyond these outcomes to include effects on lifestyle, wellbeing, and perceived health status. Adults of working age with asthma have poorer health status and quality of life outcomes than those with no asthma. This effect is independent of confounding by sociodemographic and life style factors and is evident across a range of dimensions of quality of life. In comparison with two other chronic health conditions, asthma has a larger adverse impact on health status and quality of life than diabetes.

1.2. Investigational Agent

Montelukast reversibly inhibits cysteinyl leukotrienes (CysLTs), specifically leukotrienes D4 (LTD4 [3]. LTD4 is the most potent bronchoconstricting agent on a molar basis, but Cys-LTs also have chemoattractive properties for many inflammatory cells (mainly eosinophils), effects on vascular permeability, mucous secretions and sensory nerve activation, and are responsible for part of the pathophysiology of asthma.

1.3. Dose Rational/Risk & Benefit

Montelukast 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. Given their efficacy, antiinflammatory activity, oral administration, and safety, leukotriene modifiers will play an important role in the treatment of asthmatic patient. Side effects most commonly reported above placebo included headache, otitis media, upper respiratory infection, and pharyngitis.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 4

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75510
      • Dr. Nadeem Rizvi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of Asthma
• Signed Informed Consent

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention (Montelukast); 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; 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.; Other Names: TEAM
Placebo Comparator: Placebo; Patients in placebo group will receive identical looking drug (placebo) produced by same manufactured.	Drug: Placebo; Patients in placebo group will receive identical looking drug (placebo) produced by same manufactured; Other Names: TEAM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the change in Control of Asthma using AQLQ (s) questionnaire after 4 weeks of Montelukast.	[Designated as safety issue: No]	0 days to 4 weeks
Proportion of participants experiencing an adverse event (AE)	[Designated as safety issue: Yes]	0 days to 4 weeks

Collaborators and Investigators

• Sponsor: PharmEvo Pvt Ltd
• Investigators: Study Director: Masood Jawaid, MRCS,FCPS, PharmEvo Pvt Ltd

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): December 30, 2017
• Study Completion (Actual): May 30, 2018

Study Registration Dates

• First Submitted: March 17, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (Actual): March 30, 2017

Study Record Updates

• Last Update Posted (Actual): July 9, 2018
• Last Update Submitted That Met QC Criteria: July 6, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Asthma; Quality of Life; Montelukast; Asthma control test
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: PE/PK/TEAM/IIT/2017-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No