Controller Medications in the Management of Bronchial Asthma - Full Text View

Purpose

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.

Condition	Intervention
Moderate to Severe Persistent Bronchial Asthma	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
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Budesonide Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by Government Medical College, Bhavnagar:

Primary Outcome Measures:

The primary outcome was percentage of improvement in FEV1 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

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) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	50
Study Start Date:	December 2008
Study Completion Date:	July 2009
Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: inhaled budesonide and formeterol plus oral montelukast 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	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
Experimental: inhaled budesonide and formeterol plus oral doxophylline 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	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
Experimental: Doubling the dose of inhaled budesonide and formeterol 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	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

Eligibility

Ages Eligible for Study:	15 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055041

Locations

India
Sir Takthasinhji General Hospital Bhavnagar, Gujarat, India
Bhavnagar, Gujarat, India, 364001

Sponsors and Collaborators

Government Medical College, Bhavnagar

Investigators

Principal Investigator:	Dr. Yogesh A Patel, M.B.B.S	Sir T. General Hospital and Government Medical College, Bhavnagar-364001, Gujarat, India
Study Chair:	Dr. Chandrabhanu R Tripathi, MD	Professor and Head, Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India

More Information

No publications provided

Responsible Party:	Dr. C. B. Tripathi, Professor and Head , Department of Pharmacology, Government Medical College, Bhavnagar-364001, Gujarat, India
ClinicalTrials.gov Identifier:	NCT01055041 History of Changes
Other Study ID Numbers:	Pharmacol no.03 /2008 Research
Study First Received:	January 22, 2010
Last Updated:	January 22, 2010
Health Authority:	India: Institutional Review Board

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Doxofylline
Montelukast
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Antitussive Agents
Central Nervous System Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leukotriene Antagonists

ClinicalTrials.gov processed this record on May 22, 2013