Evaluation of the Efficacy and Safety of a Fixed-dose, Single-capsule Budesonide-formoterol Combination in Uncontrolled Asthma

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of a fixed-dose, single-capsule budesonide(400µg)-formoterol(12µg) combination, in comparison with budesonide alone, both delivered via a dry powder inhaler, in 181 patients with uncontrolled asthma.This was Randomized, double-blind, multicenter, phase III, parallel clinical trial.

Detailed Description
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the age of the patients ranged from 18 to 77 years. After a run-in period of 4 weeks, during which all of the patients received budesonide twice a day, they were randomized into one of the treatment groups for 12 weeks, twice a day. The primary outcome measures were FEV1, FVC and morning PEF. We performed an intention-to-treat analysis of the data.

Official Title
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Evaluation of the Efficacy and Safety of a Fixed-dose, Single-capsule Budesonide-formoterol Combination in Uncontrolled Asthma:a Randomized, Double-blind, Multicenter, Controlled Clinical Trial.

Conditions
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Asthma

Intervention / Treatment
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* Drug: Fixed combination of budesonide and formoterol
* Drug: Budesonide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of uncontrolled asthma Age ranged from 18 to 77 years Nonsmokers Exclusion Criteria: Use of oral corticosteroids, anti-leukotrienes, immunoglobulins, beta blockers, digitalis, amiodarone, antifungals, antidepressants, monoamine oxidase inhibitors and tricyclics during the standardization Atrial fibrillation, Flutter, severe and complex tachyarrhythmias atrioventricular block 1,2 and 3 Diabetes mellitus Pregnancy Neuropsychiatric diseases Pulmonary malformations, tuberculosis, Cystic fibrosis Immunosuppressive treatment Hospitalization for asthma or respiratory infection in last 30 days Severe systemic disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 77 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fixed Combination of Budesonide and formoterol<br>Group 1 (experimental): Fixed Combination of Budesonide and formoterol | Drug: Fixed combination of budesonide and formoterol<br>* Delivered dry powder inhaler for 12 weeks.<br>* Other names: Group 1 (experimental): Budesonide and formoterol;|
| Active Comparator: Budesonide<br>Group 2 (comparator): Budesonide | Drug: Budesonide<br>* Delivered dry powder inhaler for 12 weeks.<br>* Other names: Group 2 (comparator): Budesonide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the efficacy and safety of a fixed-dose, single capsule budesonide-formoterol combination in comparison with budesonide alone in patients with uncontrolled asthma | the primary outcome Measures were FEV1(forced expiratory volume in one second), FVC(forced vital capacity)and morning PEF (peak expiratory flow). | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Budesonide, Adrenergic beta-2 receptor agonists.