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Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort Pressurized Metered-dose Inhaler (pMDI) or Oxis Turbuhaler

Primary Purpose

Stable Asthma

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
budesonide/formoterol
formoterol
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Asthma focused on measuring stable asthma, adults, formoterol, Symbicort, Oxis Turbuhaler, bronchodilation

Eligibility Criteria

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

Inclusion Criteria:

  • At least 18 years of age
  • Diagnosis of asthma and baseline lung function tests as determined by the protocol
  • Required and received treatment with inhaled corticosteroids within timeframe and doses specified in the protocol

Exclusion Criteria:

  • Severe asthma
  • Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in protocol or requires treatment with beta-blockers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    1

    2

    Arm Description

    Outcomes

    Primary Outcome Measures

    Average FEV1 during 12 hours

    Secondary Outcome Measures

    Urine levels of formoterol in 2 different formulations
    Safety profiles of formoterol in 2 different formulations

    Full Information

    First Posted
    April 1, 2008
    Last Updated
    January 21, 2011
    Sponsor
    AstraZeneca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00658255
    Brief Title
    Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort Pressurized Metered-dose Inhaler (pMDI) or Oxis Turbuhaler
    Official Title
    A Randomized, Multicenter, Open-label, Active-controlled, Single-dose, 5-period, Incomplete Block, Cross-over Study to Evaluate the Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort pMDI or Oxis Turbuhaler to Adults With Stable Asthma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    May 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    AstraZeneca

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to compare the therapeutic effects of formoterol in Symbicort with formoterol in Oxis Turbuhaler for the treatment of adults with stable asthma.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stable Asthma
    Keywords
    stable asthma, adults, formoterol, Symbicort, Oxis Turbuhaler, bronchodilation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    175 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    budesonide/formoterol
    Other Intervention Name(s)
    Symbicort
    Intervention Type
    Drug
    Intervention Name(s)
    formoterol
    Other Intervention Name(s)
    Oxis Turbuhaler
    Primary Outcome Measure Information:
    Title
    Average FEV1 during 12 hours
    Time Frame
    Once a week for 5 weeks during treatment period
    Secondary Outcome Measure Information:
    Title
    Urine levels of formoterol in 2 different formulations
    Time Frame
    Once a week (12 hour urine collection) for 5 weeks during treatment period
    Title
    Safety profiles of formoterol in 2 different formulations
    Time Frame
    Once a week for 5 weeks during treatment period

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: At least 18 years of age Diagnosis of asthma and baseline lung function tests as determined by the protocol Required and received treatment with inhaled corticosteroids within timeframe and doses specified in the protocol Exclusion Criteria: Severe asthma Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in protocol or requires treatment with beta-blockers
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael E Ruff, MD
    Organizational Affiliation
    Pharmaceutical Research & Consulting Inc
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Catherine Bonuccelli
    Organizational Affiliation
    AstraZeneca
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Relative Bronchodilating Effects of Formoterol When Administered Via Symbicort Pressurized Metered-dose Inhaler (pMDI) or Oxis Turbuhaler

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