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

Information source: Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Fixed combination of budesonide and formoterol (Drug); Budesonide (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Ache Laboratorios Farmaceuticos S.A.

Official(s) and/or principal investigator(s):
Emílio Pizzichini, Principal Investigator, Affiliation: NUPAIVA Asthma Research Center, UFSC- Brazil

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.

Clinical Details

Official 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.

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

Primary outcome: 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

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.

Eligibility

Minimum age: 18 Years. Maximum age: 77 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: April 2009
Last updated: August 30, 2012

Page last updated: August 23, 2015

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