Non-invasive Measures of Distal Lung Disease in Asthmatics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier:
NCT00250341
First received: November 4, 2005
Last updated: March 19, 2015
Last verified: March 2015
  Purpose

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


Condition Intervention Phase
Asthma
Drug: QVAR
Drug: Advair
Drug: Servent Diskus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • High resolution Cat Scans

Estimated Enrollment: 34
Study Start Date: September 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Advair Drug: Advair
250/50 mcg
Other Name: Advair Diskus
Experimental: QVAR Drug: QVAR
480 mcg
Other Name: beclomethasone dipropionate HFA
Drug: Servent Diskus
50 mcg

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250341

Locations
United States, California
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
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
ClinicalTrials.gov Identifier: NCT00250341     History of Changes
Other Study ID Numbers: IXR-403-4-196
Study First Received: November 4, 2005
Last Updated: March 19, 2015
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on March 30, 2015