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Non-invasive Measures of Distal Lung Disease in Asthmatics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00250341
First Posted: November 8, 2005
Last Update Posted: March 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )
  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: 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ):

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT00250341     History of Changes
Other Study ID Numbers: IXR-403-4-196
First Submitted: November 4, 2005
First Posted: November 8, 2005
Last Update Posted: March 20, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Beclomethasone
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Sympathomimetics