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

PharmEvo

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Placebo; Drug: Montelukast

Study type: Interventional

Funder types: Industry

Identifiers

NCT03096327

PE/PK/TEAM/IIT/2017-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups, including a placebo group

Intervention (Montelukast)

Experimental group

Description:

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.

Treatment:

Drug: Montelukast

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo