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

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ClinicalTrials.gov Identifier: NCT01676987
Recruitment Status : Completed
First Posted : August 31, 2012
Last Update Posted : August 31, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Fixed combination of budesonide and formoterol Drug: Budesonide Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : April 2009
Primary Completion Date : September 2010
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]
    the primary outcome Measures were FEV1(forced expiratory volume in one second), FVC(forced vital capacity)and morning PEF (peak expiratory flow).


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 77 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676987


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

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)
First Posted: August 31, 2012    Key Record Dates
Last Update Posted: August 31, 2012
Last Verified: August 2012

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
Formoterol Fumarate
Budesonide
Adrenergic beta-2 Receptor Agonists
Budesonide, Formoterol Fumarate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists