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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ache Laboratorios Farmaceuticos S.A.

ClinicalTrials.gov Identifier:

NCT01676987

First received: August 29, 2012

Last updated: August 30, 2012

Last verified: August 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 29, 2012

Last Updated Date

August 30, 2012

Start Date ^ICMJE

April 2009

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01676987 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

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 ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: Fixed combination of budesonide and formoterol
Delivered dry powder inhaler for 12 weeks.

Other Name: Group 1 (experimental): Budesonide and formoterol
Drug: Budesonide
Delivered dry powder inhaler for 12 weeks.

Other Name: Group 2 (comparator): Budesonide

Study Arm (s)

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

Intervention: Drug: Fixed combination of budesonide and formoterol
Active Comparator: Budesonide
Group 2 (comparator): Budesonide

Intervention: Drug: Budesonide

Publications *

Stirbulov R, Fritscher CC, Pizzichini E, Pizzichini MM. 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. J Bras Pneumol. 2012 Jul-Aug;38(4):431-7. English, Portuguese.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

181

Completion Date

June 2011

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 77 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01676987

Other Study ID Numbers ^ICMJE

Ach-ALN-04(7/07)

Has Data Monitoring Committee

Yes

Responsible Party

Ache Laboratorios Farmaceuticos S.A.

Study Sponsor ^ICMJE

Ache Laboratorios Farmaceuticos S.A.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Emílio Pizzichini

NUPAIVA Asthma Research Center, UFSC- Brazil

Information Provided By

Ache Laboratorios Farmaceuticos S.A.

Verification Date

August 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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