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

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Fixed combination of budesonide and formoterol; Drug: Budesonide

• Registration Number: NCT01676987
• Lead Sponsor: Ache Laboratorios Farmaceuticos S.A.

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2010-09
• Study Completion: 2011-06
• Status Verified: 2012-08
• Study First Submitted: 2012-08-29
• Study First Submitted QC: 2012-08-30
• Last Update Submitted: 2012-08-30
• Study First Posted: 2012-08-31
• Last Update Posted: 2012-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixed Combination of Budesonide and formoterol	Fixed combination of budesonide and formoterol	Group 1 (experimental): Fixed Combination of Budesonide and formoterol
Budesonide	Budesonide	Group 2 (comparator): Budesonide

Primary Outcome Measures

Name	Time	Method
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	12 weeks	the primary outcome Measures were FEV1(forced expiratory volume in one second), FVC(forced vital capacity)and morning PEF (peak expiratory flow).