Skip to main content
OpenTrials
Completed

NCT Number: NCT01055041

Controller Medications in the Management of Bronchial Asthma

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Moderate to Severe Persistent Bronchial Asthma

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sir Takthasinhji General Hospital Bhavnagar, Gujarat, India

Bhavnagar, Gujarat, 364001, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inhaled budesonide and formeterol plus oral montelukast

Drug

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 doxophylline

Drug

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

Drug

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

Primary outcomes

  1. The primary outcome was percentage of improvement in FEV1

    Time frame: 10 weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Government Medical College, Bhavnagar

Other

Registry information

Official study title

A Randomized, Open Labeled Comparative Study to Assess the Efficacy and Safety of Controller Medications as Add on to Inhaled Steroid and Long Acting β2 Agonist in Treatment of Moderate to Severe Persistent Bronchial Asthma

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 25, 2010
Registry last updated
Jan 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.