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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–77 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fixed combination of budesonide and formoterol

Drug

Delivered dry powder inhaler for 12 weeks.

Other names: Group 1 (experimental): Budesonide and formoterol

Budesonide

Drug

Delivered dry powder inhaler for 12 weeks.

Other names: Group 2 (comparator): Budesonide

Primary outcomes

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

Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Ache Laboratorios Farmaceuticos S.A.

Industry

Registry information

Official study 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.

Acronym: Ach-ALN

Important dates

Study start: 2009
Primary completion: 2010
Study completion: 2011
First posted: Aug 31, 2012
Registry last updated: Aug 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed