Status:
COMPLETED
Inflammatory Processes in the Airway of Asthmatics With Persistent Bronchial Hyperreactivity
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Asthma
Eligibility:
All Genders
18-60 years
Phase:
NA
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...
Detailed Description
BACKGROUND: The Inhaled Glucocorticoid Withdrawal Protocol will investigate abnormalities in the asthmatic airway that occur in the setting of a "natural" endogenous exacerbation. It is known that ch...
Eligibility Criteria
Inclusion
- 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)
- The diagnosis may also be confirmed by an abnormal bronchospastic response to methacholine or exercise as described by Cherniak
- FEV1 greater than or equal to 70% of predicted value at time of study entry
- Regular use of inhaled corticosteroids at time of study entry (at least 400 mcg of Beclomethasone or equivalent)
Exclusion
- 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)
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00217854
Start Date
September 1 2001
End Date
February 1 2011
Last Update
June 26 2017
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110