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): EmÃlio 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
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