Controller Medications in the Management of Bronchial Asthma

Government Medical College, Bhavnagar50 enrolled

Overview

The purpose of this study is to know the effect of another controller medication add on to the inhaled corticosteroid and long acting β2 agonist on clinical symptom, lung function and compliance in patients of moderate to severe persistent bronchial asthma.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Moderate to Severe Persistent Bronchial Asthma

Interventions

inhaled budesonide and formeterol plus oral montelukastDRUG

1st two weeks -run in period all the participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks- Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day plus tablet montelukast (10 mg/day)orally in the evening

inhaled budesonide and formeterol plus oral doxophyllineDRUG

1st two weeks -run in period, all participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks- Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day plus tablet doxophylline sustained release(400 mg/day)orally in the morning

Doubling the dose of inhaled budesonide and formeterol

Eligibility

Sex: ALLMin age: 15 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * aged between 15 to 65 years of either sex * had clinically diagnosed Bronchial asthma * had poor asthma control defined by ACQ score (asthma control questionnaire) of 1.5 or greater * FEV1 (Forced Expiratory Volume at 1 second) value of 50% or more of predicted * improvement in FEV1 was greater than 15% after bronchodilator inhalation Exclusion Criteria: * major illness of system other than respiratory major respiratory illness other than asthma taken long acting anti histaminic within a preceding week of enrollment Smokers Pregnant and lactating woman history of hypersensitivity to any of above drugs

Locations (1)

Sir Takthasinhji General Hospital Bhavnagar, Gujarat, India

Bhavnagar, Gujarat, India

Outcomes

Primary Outcomes

The primary outcome was percentage of improvement in FEV1

Time frame: 10 weeks

Secondary Outcomes

Improvement in PEFR (Peak expiratory flow rate), ACQ scores(asthma control questionnaire score), rates of adverse drug reaction and EPACs (episodes of poor asthma control)

Time frame: 10 weeks

Data from ClinicalTrials.gov

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