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Non-invasive Measures of Distal Lung Disease in Asthmatics

Sponsor
Teva Branded Pharmaceutical Products R&D, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00250341
Collaborator
(none)
34
Enrollment
1
Location
2
Arms
24
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 4, single center study conducted in mild-to moderate asthmatics.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

The study consists of 3 phases. There are 7 study visits.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
34 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Non-Invasive Measures of Distal Lung Disease in Asthmatics Before and After Therapy Directed at the Proximal vs. Distal Lung
Actual Study Start Date :
Sep 30, 2005
Actual Primary Completion Date :
Sep 30, 2007
Actual Study Completion Date :
Sep 30, 2007

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Advair

Drug: Advair
250/50 mcg
Other Names:
  • Advair Diskus

    		•
    Experimental: QVAR

    Drug: QVAR
    480 mcg
    Other Names:
  • beclomethasone dipropionate HFA

    • Drug: Servent Diskus
    50 mcg

    Outcome Measures

    Primary Outcome Measures

    1. High resolution Cat Scans []

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 18-65 years old

    • Currently using SABA prn or a low-to-moderate persistent asthma

    Exclusion Criteria:
    • Tobacco use within 1 year or >= 5 pack years

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA Los Angeles California United States 90095

    Sponsors and Collaborators

    • Teva Branded Pharmaceutical Products R&D, Inc.

    Investigators

    • Principal Investigator: Michelle Zeidler, MD, University of California, Los Angeles

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Teva Branded Pharmaceutical Products R&D, Inc.
    ClinicalTrials.gov Identifier:
    NCT00250341
    Other Study ID Numbers:
    • IXR-403-4-196
    First Posted:
    Nov 8, 2005
    Last Update Posted:
    Dec 2, 2021
    Last Verified:
    Nov 1, 2021
    Additional relevant MeSH terms:
    Lung Diseases
    Beclomethasone
    Fluticasone-Salmeterol Drug Combination

    Study Results

    No Results Posted as of Dec 2, 2021