Back to results

Controller Medications in the Management of Bronchial Asthma

Primary Purpose

Moderate to Severe Persistent Bronchial Asthma

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

inhaled budesonide and formeterol plus oral montelukast

inhaled budesonide and formeterol plus oral doxophylline

Doubling the dose of inhaled budesonide and formeterol

About this trial

This is an interventional treatment trial for Moderate to Severe Persistent Bronchial Asthma

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Sir Takthasinhji General Hospital Bhavnagar, Gujarat, India

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

inhaled budesonide and formeterol plus oral montelukast

inhaled budesonide and formeterol plus oral doxophylline

Doubling the dose of inhaled budesonide and formeterol

Arm 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

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

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

Outcomes

Primary Outcome Measures

The primary outcome was percentage of improvement in FEV1

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT01055041

First Posted

January 22, 2010

Last Updated

January 22, 2010

Sponsor

Government Medical College, Bhavnagar

1. Study Identification

Unique Protocol Identification Number

NCT01055041

Brief Title

Controller Medications in the Management of Bronchial Asthma

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2010

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Government Medical College, Bhavnagar

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Moderate to Severe Persistent Bronchial Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

inhaled budesonide and formeterol plus oral montelukast

Arm Type

Experimental

Arm Description

Arm Title

inhaled budesonide and formeterol plus oral doxophylline

Arm Type

Experimental

Arm 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

Arm Title

Doubling the dose of inhaled budesonide and formeterol

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

inhaled budesonide and formeterol plus oral montelukast

Intervention 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 tablet montelukast (10 mg/day)orally in the evening

Intervention Type

Drug

Intervention Name(s)

inhaled budesonide and formeterol plus oral doxophylline

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Doubling the dose of inhaled budesonide and formeterol

Intervention Description

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 Outcome Measure Information:

Title

The primary outcome was percentage of improvement in FEV1

Time Frame

10 weeks

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr. Yogesh A Patel, M.B.B.S

Organizational Affiliation

Sir T. General Hospital and Government Medical College, Bhavnagar-364001, Gujarat, India

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dr. Chandrabhanu R Tripathi, MD

Organizational Affiliation

Professor and Head, Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India

Official's Role

Study Chair

Facility Information:

Facility Name

Sir Takthasinhji General Hospital Bhavnagar, Gujarat, India

City

Bhavnagar

State/Province

Gujarat

ZIP/Postal Code

364001

Country

India

12. IPD Sharing Statement

Learn more about this trial

Controller Medications in the Management of Bronchial Asthma

We'll reach out to this number within 24 hrs