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Non-invasive Measures of Distal Lung Disease in Asthmatics

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
QVAR
Advair
Servent Diskus
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Advair

QVAR

Arm Description

Outcomes

Primary Outcome Measures

High resolution Cat Scans

Secondary Outcome Measures

Full Information

First Posted
November 4, 2005
Last Updated
November 19, 2021
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00250341
Brief Title
Non-invasive Measures of Distal Lung Disease in Asthmatics
Official Title
Non-Invasive Measures of Distal Lung Disease in Asthmatics Before and After Therapy Directed at the Proximal vs. Distal Lung
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
September 30, 2005 (Actual)
Primary Completion Date
September 30, 2007 (Actual)
Study Completion Date
September 30, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a Phase 4, single center study conducted in mild-to moderate asthmatics.
Detailed Description
The study consists of 3 phases. There are 7 study visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Advair
Arm Type
Active Comparator
Arm Title
QVAR
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
QVAR
Other Intervention Name(s)
beclomethasone dipropionate HFA
Intervention Description
480 mcg
Intervention Type
Drug
Intervention Name(s)
Advair
Other Intervention Name(s)
Advair Diskus
Intervention Description
250/50 mcg
Intervention Type
Drug
Intervention Name(s)
Servent Diskus
Intervention Description
50 mcg
Primary Outcome Measure Information:
Title
High resolution Cat Scans

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Zeidler, MD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Non-invasive Measures of Distal Lung Disease in Asthmatics

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