NCT01676987

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

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Ache Laboratorios Farmaceuticos S.A. · Industry
• Sex: All
• Age: 18 Years – 77 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Fixed combination of budesonide and formoterol	Delivered dry powder inhaler for 12 weeks.
DRUG	Budesonide	Delivered dry powder inhaler for 12 weeks.

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-09-01
• Completion: 2011-06-01
• First posted: 2012-08-31
• Last updated: 2012-08-31