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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier:
NCT01676987
First received: August 29, 2012
Last updated: August 30, 2012
Last verified: August 2012

August 29, 2012
August 30, 2012
April 2009
September 2010   (final data collection date for primary outcome measure)
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 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
the primary outcome Measures were FEV1(forced expiratory volume in one second), FVC(forced vital capacity)and morning PEF (peak expiratory flow).
Same as current
Complete list of historical versions of study NCT01676987 on ClinicalTrials.gov Archive Site
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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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: Fixed combination of budesonide and formoterol
    Delivered dry powder inhaler for 12 weeks.
    Other Name: Group 1 (experimental): Budesonide and formoterol
  • Drug: Budesonide
    Delivered dry powder inhaler for 12 weeks.
    Other Name: Group 2 (comparator): Budesonide
  • Experimental: Fixed Combination of Budesonide and formoterol
    Group 1 (experimental): Fixed Combination of Budesonide and formoterol
    Intervention: Drug: Fixed combination of budesonide and formoterol
  • Active Comparator: Budesonide
    Group 2 (comparator): Budesonide
    Intervention: Drug: Budesonide
Stirbulov R, Fritscher CC, Pizzichini E, Pizzichini MM. 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. J Bras Pneumol. 2012 Jul-Aug;38(4):431-7. English, Portuguese.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
181
June 2011
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 77 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01676987
Ach-ALN-04(7/07)
Yes
Ache Laboratorios Farmaceuticos S.A.
Ache Laboratorios Farmaceuticos S.A.
Not Provided
Principal Investigator: Emílio Pizzichini NUPAIVA Asthma Research Center, UFSC- Brazil
Ache Laboratorios Farmaceuticos S.A.
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP