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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 23, 2014