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

Asthma Clinical Trial

— Ach-ALN  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01676987
• Other study ID #: Ach-ALN-04(7/07)
• Status: Completed
• Phase: Phase 3
• First received: August 29, 2012
• Last updated: August 30, 2012
• Start date: April 2009
• Est. completion date: June 2011

Study information

• Verified date: August 2012
• Source: Ache Laboratorios Farmaceuticos S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: June 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 77 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Fixed combination of budesonide and formoterol
Delivered dry powder inhaler for 12 weeks.
• Budesonide
Delivered dry powder inhaler for 12 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ache Laboratorios Farmaceuticos S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the primary outcome Measures were FEV1(forced expiratory volume in one second), FVC(forced vital capacity)and morning PEF (peak expiratory flow).	12 weeks