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New Version Pulmicort Turbuhaler USA Adults

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
budesonide
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Pulmicort, Turbuhaler, Budesonide, Flexhaler

Eligibility Criteria

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

Inclusion Criteria:

  • Males and females at least 18 years old with a diagnosis of asthma (as defined by the ATS) for at least 6 months.
  • To enter the run in period, subjects were also required to have the following:
  • A forced expiratory volume (FEV1) in 1 second of 60% to 90% of predicted normal, airway reversibility of at least 12% and 0.20 L, use of orally inhaled corticosteroids for at least 3 months prior to the study.
  • At Visit 2, subjects who met additional entry criteria related to rescue medication use and asthma symptom scores during the run in period plus visit specific FEV1 requirements were assigned to randomized treatments

Exclusion Criteria:

  • Life threatening asthma, Two or more overnight hospitalisations for asthma within 1 year or any emergency room visit for asthma within 6 months of starting study.
  • Use of steroid tablets or injections during the month (28 days) prior to Visit 1 and use of other asthma medicines (except rescue medication) within 2 weeks prior to the study.
  • Any acute exacerbation of asthma or a respiratory tract infection within 30 days prior to the study. Subject must not smoke or have smoked within 6 months of the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    Arm Description

    Pulmicort

    Placebo

    Outcomes

    Primary Outcome Measures

    Change from Baseline in Forced Expiratory Volume in 1 second

    Secondary Outcome Measures

    Change from baseline in Forced Vital Capacity, Morning Peak Expiratory Flow, Daytime and nighttime asthma symptom scores, beta-agonist use and discontinuation rate.
    Incidence of Adverse Events
    Pharmacokinetics of budesonide (AUC, maximum concentration and time to maximum concentration)

    Full Information

    First Posted
    March 18, 2008
    Last Updated
    January 21, 2011
    Sponsor
    AstraZeneca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00642187
    Brief Title
    New Version Pulmicort Turbuhaler USA Adults
    Official Title
    A Placebo-controlled Comparison of the Efficacy and Safety of the Current US Version of Pulmicort (Budesonide) Turbuhaler and the New Version of Pulmicort Turbuhaler in Asthmatic Adults Currently Treated With Inhaled Steroids.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2002 (undefined)
    Primary Completion Date
    October 2004 (Actual)
    Study Completion Date
    October 2004 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    AstraZeneca

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    A comparison of the safety, efficacy and budesonide pharmacokinetics of the currently approved Pulmicort Turbuhaler with a new version of the inhaler, in adult patients who have asthma and are currently being treated with inhaled steroids. In addition the study evaluated the functionality of the new inhaler at the end of its intended life.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma
    Keywords
    Asthma, Pulmicort, Turbuhaler, Budesonide, Flexhaler

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Single
    Allocation
    Randomized
    Enrollment
    525 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    Pulmicort
    Arm Title
    2
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Drug
    Intervention Name(s)
    budesonide
    Other Intervention Name(s)
    Pulmicort
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    Change from Baseline in Forced Expiratory Volume in 1 second
    Time Frame
    Week 2, 4 and 8, then at week 12
    Secondary Outcome Measure Information:
    Title
    Change from baseline in Forced Vital Capacity, Morning Peak Expiratory Flow, Daytime and nighttime asthma symptom scores, beta-agonist use and discontinuation rate.
    Time Frame
    Week 2, 4 and 8, then at week 12
    Title
    Incidence of Adverse Events
    Time Frame
    Week 2,4 and 8, then at week 12
    Title
    Pharmacokinetics of budesonide (AUC, maximum concentration and time to maximum concentration)
    Time Frame
    6 or 12 hours post dose

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Males and females at least 18 years old with a diagnosis of asthma (as defined by the ATS) for at least 6 months. To enter the run in period, subjects were also required to have the following: A forced expiratory volume (FEV1) in 1 second of 60% to 90% of predicted normal, airway reversibility of at least 12% and 0.20 L, use of orally inhaled corticosteroids for at least 3 months prior to the study. At Visit 2, subjects who met additional entry criteria related to rescue medication use and asthma symptom scores during the run in period plus visit specific FEV1 requirements were assigned to randomized treatments Exclusion Criteria: Life threatening asthma, Two or more overnight hospitalisations for asthma within 1 year or any emergency room visit for asthma within 6 months of starting study. Use of steroid tablets or injections during the month (28 days) prior to Visit 1 and use of other asthma medicines (except rescue medication) within 2 weeks prior to the study. Any acute exacerbation of asthma or a respiratory tract infection within 30 days prior to the study. Subject must not smoke or have smoked within 6 months of the study.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bertil Andersson
    Organizational Affiliation
    AZ employee
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Lars-Göran Carlsson
    Organizational Affiliation
    AZ employee
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    New Version Pulmicort Turbuhaler USA Adults

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