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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Fixed combination of budesonide and formoterol
Budesonide
Sponsored by
Ache Laboratorios Farmaceuticos S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Budesonide, Adrenergic beta-2 receptor agonists.

Eligibility Criteria

18 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Fixed Combination of Budesonide and formoterol

    Budesonide

    Arm Description

    Group 1 (experimental): Fixed Combination of Budesonide and formoterol

    Group 2 (comparator): Budesonide

    Outcomes

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

    Secondary Outcome Measures

    Full Information

    First Posted
    August 29, 2012
    Last Updated
    August 30, 2012
    Sponsor
    Ache Laboratorios Farmaceuticos S.A.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01676987
    Brief Title
    Evaluation of the Efficacy and Safety of a Fixed-dose, Single-capsule Budesonide-formoterol Combination in Uncontrolled Asthma
    Acronym
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2009 (undefined)
    Primary Completion Date
    September 2010 (Actual)
    Study Completion Date
    June 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ache Laboratorios Farmaceuticos S.A.

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma
    Keywords
    Asthma, Budesonide, Adrenergic beta-2 receptor agonists.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    181 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Fixed Combination of Budesonide and formoterol
    Arm Type
    Experimental
    Arm Description
    Group 1 (experimental): Fixed Combination of Budesonide and formoterol
    Arm Title
    Budesonide
    Arm Type
    Active Comparator
    Arm Description
    Group 2 (comparator): Budesonide
    Intervention Type
    Drug
    Intervention Name(s)
    Fixed combination of budesonide and formoterol
    Other Intervention Name(s)
    Group 1 (experimental): Budesonide and formoterol
    Intervention Description
    Delivered dry powder inhaler for 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Budesonide
    Other Intervention Name(s)
    Group 2 (comparator): Budesonide
    Intervention Description
    Delivered dry powder inhaler for 12 weeks.
    Primary Outcome Measure Information:
    Title
    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
    Description
    the primary outcome Measures were FEV1(forced expiratory volume in one second), FVC(forced vital capacity)and morning PEF (peak expiratory flow).
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    77 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Emílio Pizzichini
    Organizational Affiliation
    NUPAIVA Asthma Research Center, UFSC- Brazil
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22964926
    Citation
    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. doi: 10.1590/s1806-37132012000400004. English, Portuguese.
    Results Reference
    derived

    Learn more about this trial

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

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