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

NCT ID: NCT01676987

Last Updated: 2012-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Asthma

Keywords

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Asthma Budesonide Adrenergic beta-2 receptor agonists.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fixed Combination of Budesonide and formoterol

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

Group Type EXPERIMENTAL

Fixed combination of budesonide and formoterol

Intervention Type DRUG

Delivered dry powder inhaler for 12 weeks.

Budesonide

Group 2 (comparator): Budesonide

Group Type ACTIVE_COMPARATOR

Budesonide

Intervention Type DRUG

Delivered dry powder inhaler for 12 weeks.

Interventions

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Fixed combination of budesonide and formoterol

Delivered dry powder inhaler for 12 weeks.

Intervention Type DRUG

Budesonide

Delivered dry powder inhaler for 12 weeks.

Intervention Type DRUG

Other Intervention Names

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Group 1 (experimental): Budesonide and formoterol Group 2 (comparator): Budesonide

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

77 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ache Laboratorios Farmaceuticos S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emílio Pizzichini

Role: PRINCIPAL_INVESTIGATOR

NUPAIVA Asthma Research Center, UFSC- Brazil

References

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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. doi: 10.1590/s1806-37132012000400004. English, Portuguese.

Reference Type DERIVED
PMID: 22964926 (View on PubMed)

Other Identifiers

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Ach-ALN-04(7/07)

Identifier Type: -

Identifier Source: org_study_id