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

Ache Laboratorios Farmaceuticos

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Budesonide; Drug: Fixed combination of budesonide and formoterol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01676987

Ach-ALN-04(7/07)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 181 patients

Sex: All

Ages: 18 to 77 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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181 participants in 2 patient groups

Fixed Combination of Budesonide and formoterol

Experimental group

Description:

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

Treatment:

Drug: Fixed combination of budesonide and formoterol

Budesonide

Active Comparator group

Description:

Group 2 (comparator): Budesonide

Treatment:

Drug: Budesonide