Controller Medications in the Management of Bronchial Asthma

Moderate to Severe Persistent Bronchial Asthma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01055041
• Other study ID #: Pharmacol no.03 /2008 Research
• Status: Completed
• Phase: N/A
• First received: January 22, 2010
• Last updated: January 22, 2010
• Start date: December 2008
• Est. completion date: July 2009

Study information

• Verified date: January 2010
• Source: Government Medical College, Bhavnagar
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Moderate to Severe Persistent Bronchial Asthma

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
India	Sir Takthasinhji General Hospital Bhavnagar, Gujarat, India	Bhavnagar	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Government Medical College, Bhavnagar

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome was percentage of improvement in FEV1		10 weeks	No
Secondary	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)		10 weeks	Yes