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Double-blind, randomised, controlled trial assessing controller medications in asthma
A R Shah1, L D Sharples, R N Solanki
1Department of Chest Diseases, Civil Hospital, Ahmedabad, India. drashishshah@yahoo.com
Respiration; International Review of Thoracic Diseases
|January 13, 2006
Summary
Adding montelukast to budesonide significantly improved asthma control and lung function compared to high-dose budesonide or theophylline. This combination therapy offers a safe and effective option for managing inadequately controlled asthma.
Area of Science:
- Pulmonology
- Pharmacology
- Clinical Medicine
Background:
- Asthma management often requires optimizing controller medications.
- Investigating add-on therapies aims to improve symptom control and reduce reliance on high-dose inhaled corticosteroids.
Purpose of the Study:
- To compare the efficacy of adding montelukast or sustained-release theophylline to inhaled budesonide versus high-dose budesonide alone in patients with uncontrolled asthma.
- To assess the impact on clinical symptoms and pulmonary function.
Main Methods:
- A randomized, double-blind study involving 90 patients with incompletely controlled asthma.
- Three groups: high-dose budesonide, budesonide plus theophylline, and budesonide plus montelukast.
- Primary endpoints included forced expiratory volume in 1 second (FEV1) and peak expiratory flow rate (PEFR).
Main Results:
- All treatment groups showed significant improvements in FEV1 and PEFR after 8 weeks.
- Montelukast group demonstrated superior improvements in PEFR and FEV1 compared to both high-dose budesonide and theophylline groups.
- Statistical significance was observed for all key comparisons.
Conclusions:
- Montelukast, when added to budesonide, provides greater pulmonary function improvements than high-dose budesonide or theophylline.
- This combination therapy is a safe and effective strategy for enhancing asthma control.
- The findings support individualized treatment approaches in asthma management.