Inflammatory Processes in the Airway of Asthmatics With Persistent Bronchial Hyperreactivity
- Registration Number
- NCT00217854
- Lead Sponsor
- Washington University School of Medicine
- Brief Summary
The purpose of this study is to examine inflammatory processes in the airway of moderate to severe persistent asthmatics who have persistent bronchial hyperreactivity despite chronic administration of inhaled glucocorticoids.
- Detailed Description
BACKGROUND:
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Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
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Symptoms of asthma as defined by the American Thoracic Society (ATS) definition. This includes the following:
- history of episodic shortness of breath (with or without associated wheezing) in association with reversible obstructive airways disease with at least a 20% decrement in FEV1 and FVC (from predicted values) that is documented at some time point by pulmonary function tests
- an improvement in expiratory flow rates of at least 15% of predicted values after inhalation of a beta-2 selective bronchodilator medication or other previous treatment (e.g. corticosteroids)
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The diagnosis may also be confirmed by an abnormal bronchospastic response to methacholine or exercise as described by Cherniak
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FEV1 greater than or equal to 70% of predicted value at time of study entry
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Regular use of inhaled corticosteroids at time of study entry (at least 400 mcg of Beclomethasone or equivalent)
- Used inhaled cromolyn (Intal) or nedocromil (Tilade) in the month prior to study entry
- History of severe asthma requiring intubation
- Any cardiopulmonary or neurologic abnormality with which the risk of performing the procedure would outweigh the potential benefits (other than asthma)
- Upper respiratory tract infection or clinical evidence of a sinus infection during the month preceding the test
- History of cigarette smoking within the 5 years prior to study entry or greater than 10 pack-years total
- Pregnant or refuses to undergo urine pregnancy testing if female of child-bearing age (women of childbearing potential will not be challenged [methacholine challenge] unless they have had a menstrual period in the last 10 days or a negative pregnancy test within 2 weeks or are practicing adequate contraception)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open label inhaled fluticasone Bronchoscopic Patients are treated with open label high dose fluticasone for 30 days then discontinued. Comparisons are pre- and post- treatment single arm.
- Primary Outcome Measures
Name Time Method change in CD3 positive T cells in the airway submucosa Measured at Week 4
- Secondary Outcome Measures
Name Time Method inflammatory cell markers in the airway (CD4, CD8, CD68, CD45, EG2/MBP, tryptase, and neutrophil elastase) Measured at Week 4 RANTES expression in airway Measured at Week 4 FEV1, peak expiratory flows Measured at Week 4 methacholine PC20 Measured at Week 4 asthma symptom score Measured at Week 4
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States