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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ache Laboratorios Farmaceuticos S.A.
• Treatments: Adrenergic beta-2 Receptor Agonists; Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Formoterol Fumarate

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