Controller Medications in the Management of Bronchial Asthma

Government Medical College, Bhavnagar

Status: Completed

Conditions: Moderate to Severe Persistent Bronchial Asthma

Treatments: Drug: inhaled budesonide and formeterol plus oral montelukast; Drug: inhaled budesonide and formeterol plus oral doxophylline; Drug: Doubling the dose of inhaled budesonide and formeterol

Study type: Interventional

Funder types: Other

Identifiers

NCT01055041

Pharmacol no.03 /2008 Research

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

inhaled budesonide and formeterol plus oral montelukast

Experimental group

Description:

1st two weeks -run in period .All three 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

Treatment:

Drug: inhaled budesonide and formeterol plus oral montelukast

inhaled budesonide and formeterol plus oral doxophylline

Experimental group

Description:

1st two weeks -run in period, all three participants prescribed Metered dose inhaler (budesonide 200 mcg/puff + formeterol 6 mcg/puff) two times a day Next 8 weeks

Treatment:

Drug: inhaled budesonide and formeterol plus oral doxophylline

Doubling the dose of inhaled budesonide and formeterol

Experimental group

Description:

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 metered dose inhaler of budesonide (200 mcg/puff) two times a day

Treatment:

Drug: Doubling the dose of inhaled budesonide and formeterol