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

August 30, 2012 updated by: Ache Laboratorios Farmaceuticos S.A.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

181

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 77 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ache Laboratorios Farmaceuticos S.A.

Investigators

  • Principal Investigator: Emílio Pizzichini, NUPAIVA Asthma Research Center, UFSC- Brazil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

August 29, 2012

First Submitted That Met QC Criteria

August 30, 2012

First Posted (Estimate)

August 31, 2012

Study Record Updates

Last Update Posted (Estimate)

August 31, 2012

Last Update Submitted That Met QC Criteria

August 30, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ach-ALN-04(7/07)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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