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Controller Medications in the Management of Bronchial Asthma

NCT01055041 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2010-01-25

No results posted yet for this study

Summary

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.

Conditions

  • Moderate to Severe Persistent Bronchial Asthma

Interventions

DRUG

inhaled budesonide and formeterol plus oral montelukast

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

DRUG

inhaled budesonide and formeterol plus oral doxophylline

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

DRUG

Doubling the dose of inhaled budesonide and formeterol

1st two weeks -run in period, all groups 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

Sponsors & Collaborators

  • Government Medical College, Bhavnagar

    lead OTHER

Principal Investigators

  • Dr. Yogesh A Patel, M.B.B.S · Sir T. General Hospital and Government Medical College, Bhavnagar-364001, Gujarat, India

  • Dr. Chandrabhanu R Tripathi, MD · Professor and Head, Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-06-30
Completion
2009-07-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01055041 on ClinicalTrials.gov