Trial | NCT01055041  Report issue

Title

Controller Medications in the Management of Bronchial Asthma
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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    montelukast formoterol budesonide Doxofylline ...

  • Study Participants

    50
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.
Study Started
Dec 31
2008
Primary Completion
Jun 30
2009
Study Completion
Jul 31
2009
Last Update
Jan 25
2010
Estimate

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

inhaled budesonide and formeterol plus oral montelukast Experimental

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

inhaled budesonide and formeterol plus oral doxophylline Experimental

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

Doubling the dose of inhaled budesonide and formeterol Experimental

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

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
No Results Posted