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

Asthma Clinical Trial

— TEAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03096327
• Other study ID #: PE/PK/TEAM/IIT/2017-01
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: April 2018
• Source: PharmEvo Pvt Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 30, 2018
• Est. primary completion date: December 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
Pakistan	Dr. Nadeem Rizvi	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
PharmEvo Pvt Ltd

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Proportion of participants experiencing an adverse event (AE)	[Designated as safety issue: Yes]	0 days to 4 weeks