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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Asthma
 Drug: Fixed combination of budesonide and formoterol
Drug: Budesonide
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Ache Laboratorios Farmaceuticos S.A.:

Primary Outcome Measures:
  • 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).


Enrollment: 181
Study Start Date: April 2009
Study Completion Date: June 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fixed Combination of Budesonide and formoterol
Group 1 (experimental): Fixed Combination of Budesonide and formoterol
 Drug: Fixed combination of budesonide and formoterol
Delivered dry powder inhaler for 12 weeks.
Other Name: Group 1 (experimental): Budesonide and formoterol
Active Comparator: Budesonide
Group 2 (comparator): Budesonide
 Drug: Budesonide
Delivered dry powder inhaler for 12 weeks.
Other Name: Group 2 (comparator): Budesonide

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

Ages Eligible for Study:   18 Years to 77 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676987

Sponsors and Collaborators
Ache Laboratorios Farmaceuticos S.A.
Investigators
Principal Investigator: Emílio Pizzichini NUPAIVA Asthma Research Center, UFSC- Brazil
  More Information

No publications provided by Ache Laboratorios Farmaceuticos S.A.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier: NCT01676987     History of Changes
Other Study ID Numbers: Ach-ALN-04(7/07)
Study First Received: August 29, 2012
Last Updated: August 30, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Ache Laboratorios Farmaceuticos S.A.:
Asthma
Budesonide
Adrenergic beta-2 receptor agonists.

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol
Symbicort
Adrenergic beta-2 Receptor Agonists
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013