Non-invasive Measures of Distal Lung Disease in Asthmatics

November 19, 2021 updated by: Teva Branded Pharmaceutical Products R&D, Inc.

Non-Invasive Measures of Distal Lung Disease in Asthmatics Before and After Therapy Directed at the Proximal vs. Distal Lung

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
High resolution Cat Scans

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2005

Primary Completion (Actual)

September 30, 2007

Study Completion (Actual)

September 30, 2007

Study Registration Dates

First Submitted

November 4, 2005

First Submitted That Met QC Criteria

November 7, 2005

First Posted (Estimate)

November 8, 2005

Study Record Updates

Last Update Posted (Actual)

December 2, 2021

Last Update Submitted That Met QC Criteria

November 19, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IXR-403-4-196

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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