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

Asthma Clinical Trial

Official title:
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.

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01676987
Study type Interventional
Source Ache Laboratorios Farmaceuticos S.A.
Contact
Status Completed
Phase Phase 3
Start date April 2009
Completion date June 2011
View Details
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