Mentored Patient-Oriented Research Career Development Award

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00203684
First received: September 13, 2005
Last updated: October 18, 2007
Last verified: September 2005
  Purpose

Asthmatics have inflammation in the large airways (tubes through which air travels in and out of the lungs). The large airways are located in the central lung. New research shows that asthmatics also have inflammation in the small airways. The small airways are located in the peripheral lung (the parts of the lung away from the central lung).

Until now, most of the inhaled medications available have been made up of big particles that never reach the peripheral lung. The purpose of this study is to try to measure the level of inflammation in the peripheral lung in asthmatics and see if this inflammation can be decreased with different types of inhaled corticosteroids. The investigators will check airway inflammation before and after use of an inhaled corticosteroid that has a large particle size and should only reach the large airways (Flunisolide-CFC), and before and after use of an inhaled, small particle corticosteroid that should reach both the large and small airways (Flunisolide-HFA).

Subjects will make 6 study visits over two phases of the study. In the first phase, the investigators will collect baseline information about subjects while they are using placebo (inactive substance). In the second phase, subjects will take either the large or small particle corticosteroid.

Visits will involve questionnaires and various tests measuring lung function (such as spirometry, forced oscillation, and methacholine challenge). Exhaled nitric oxide will be measured as an indication of inflammation. Subjects will also measure and make note of lung function at home twice daily using a peak expiratory flow meter. Two of the visits will involve fiberoptic bronchoscopy so that the investigators may collect cells and tissue samples without surgery. Another two of the visits will involve the use of high resolution computed tomography (HRCT) scans to indirectly evaluate disease in distant parts of the lungs.


Condition Intervention Phase
Asthma
Distal Lung Inflammation
Drug: Flunisolide-HFA
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: The Effects of Different Sized Inhaled Corticosteroids on Peripheral Lung Inflammation in Asthma Assessed Through Lung Tissue Samples (SMART Protocol)

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 18 to 50 years. Younger subjects are excluded due to greater concerns with respect to risks from radiation and bronchoscopy in children; older subjects due to greater risks of bronchoscopy.
  • Mild to moderate persistent asthma (forced expiratory volume in 1 second [FEV1] greater than or equal to 70% predicted {Hankinson, 1999 #266}; PC20 less than or equal to 8 mg/ml) and currently using only short acting inhaled beta agonists as needed for control of asthma symptoms.

Exclusion Criteria:

  • The use of the following medications will exclude subjects from entering the study:

    • Oral or parenteral steroids within 6 months
    • Inhaled corticosteroids within 3 months
    • Antileukotrienes, b-adrenergic blocking agents, inhaled cromolyn sodium or nedocromil, macrolide antibiotics, or investigational drugs within 1 month
    • Drugs or exposures which, in the opinion of the investigators, could influence study results
  • Tobacco within 1 year or less than or equal to 5 pack years.
  • Pregnant women, lactating women, or women of childbearing age not willing to take precautions to avoid becoming pregnant during the study.
  • Subjects with upper respiratory infection or receiving an influenza vaccine within 6 weeks of the study.
  • Subjects with a history of allergy or adverse reaction to inhaled beta agonists or methacholine.
  • Subjects with clinically significant evidence of cardiovascular, central nervous system, endocrine, gastrointestinal, hematopoietic, hepatic, psychiatric, or respiratory (other than asthma) disease

Eligibility will be determined by an investigator using the above inclusion/exclusion criteria.

No subjects will be excluded based on race or gender. Subjects must be between 18 and 50 in order to avoid greater risks of bronchoscopy and, in those under 18, exposure to radiation. To avoid risks, women will not be enrolled if pregnant, lactating or of childbearing potential and unwilling to undertake appropriate precautions.

  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: NCT00203684

Contacts
Contact: Michelle Ziedler, MD 310-825-3806

Locations
United States, California
UCLA Asthma and Cough Center Recruiting
Los Angeles, California, United States, 90095
Contact: Michelle Ziedler, MD    310-825-3806      
Principal Investigator: Michelle Ziedler, MD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Michelle Ziedler, MD University of California, Los Angeles
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00203684     History of Changes
Other Study ID Numbers: 5K23RR018538-03, NIH grant #5K23RR018538-03
Study First Received: September 13, 2005
Last Updated: October 18, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Inflammation
Pneumonia
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Respiratory Tract Infections
Flunisolide
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 22, 2014