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

Sponsor

Ache Laboratorios Farmaceuticos S.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT01676987

Collaborator

(none)

181

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Fixed combination of budesonide and formoterol Drug: Budesonide	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

181 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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.

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Sep 1, 2010

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fixed Combination of Budesonide and formoterol Group 1 (experimental): Fixed Combination of Budesonide and formoterol	Drug: Fixed combination of budesonide and formoterol Delivered dry powder inhaler for 12 weeks. Other Names: Group 1 (experimental): Budesonide and formoterol
Active Comparator: Budesonide Group 2 (comparator): Budesonide	Drug: Budesonide Delivered dry powder inhaler for 12 weeks. Other Names: Group 2 (comparator): Budesonide

Arm

Intervention/Treatment

Experimental: Fixed Combination of Budesonide and formoterol

Group 1 (experimental): Fixed Combination of Budesonide and formoterol

Drug: Fixed combination of budesonide and formoterol

Delivered dry powder inhaler for 12 weeks.

Other Names:

Group 1 (experimental): Budesonide and formoterol

Active Comparator: Budesonide

Group 2 (comparator): Budesonide

Drug: Budesonide

Delivered dry powder inhaler for 12 weeks.

Other Names:

Group 2 (comparator): Budesonide

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 77 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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