Inflammatory Processes in the Airway of Asthmatics With Persistent Bronchial Hyperreactivity

Completed · Not applicable

Conditions studied: Asthma

In brief

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.

Key facts

Study ID

NCT00217854

Run by

Washington University School of Medicine

People needed

27

Starts

2001-09-01

Expected to finish

2011-02-01

Last updated by the study team

2017-06-26

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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