Trial | NCT01676987  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    formoterol budesonide ...

  • Study Participants

    181
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.
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 Started
Apr 30
2009
Primary Completion
Sep 30
2010
Study Completion
Jun 30
2011
Last Update
Aug 31
2012
Estimate

Drug Fixed combination of budesonide and formoterol

Delivered dry powder inhaler for 12 weeks.

  • Other names: Group 1 (experimental): Budesonide and formoterol

Drug Budesonide

Delivered dry powder inhaler for 12 weeks.

  • Other names: Group 2 (comparator): Budesonide

Fixed Combination of Budesonide and formoterol Experimental

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

Budesonide Active Comparator

Group 2 (comparator): Budesonide

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
No Results Posted