Asthma Clinical Trial
To examine the cellular and molecular mechanisms of corticosteroid and leukotriene receptor antagonists, focusing on their effects on T lymphocytes during both chronic (18 months) and acute therapy.
BACKGROUND:
Asthma is a chronic inflammatory disease. T lymphocytes are essential for initiating and
maintaining the asthmatic inflammatory immune response. Corticosteroid treatment targets
several inflammatory responses, including T lymphocytemediated responses. In addition,
leukotriene receptor antagonists (LTRA) may influence T cell activation. To investigate the
effects of these two controller agents in the treatment of asthma on airway function is the
goal of the IMPACT clinical trial in mild chronic adult asthmatics. The Improving Asthma
Control Trial (IMPACT) is one of the trials within the NHLBI-supported Asthma Clinical
Research Network (ACRN). IMPACT is a double-blind, randomized, parallel group design
clinical trial to determine the best long-term strategy for treating adults with mild asthma
who experience symptoms more than occasionally. The trial will test whether these patients
should be taking anti-inflammatory medications on a daily basis and whether a newer class of
medications provides the same benefit as older drugs. In the IMPACT study, 234 adults with
mild asthma who have more than occasional symptoms will be enrolled in six clinical research
centers. Following an initial evaluation, patients will be randomized to receive either a
twice daily inhaled corticosteroid, a twice daily anti-leukotriene, or a placebo. All
patients will receive treatment for symptoms if and when they occur. The results should
demonstrate whether medication is required on a daily basis by these patients, and if so,
whether inhaled corticosteroids and leukotriene modifiers are equally effective. Recruitment
began in May, 2000. The trial is expected to be completed in 2003.
The study is in response to an initiative "Ancillary Studies in Heart, Lung, and Blood
Disease Trials" released by the National Heart, Lung, and Blood Institute in June 2000.
DESIGN NARRATIVE:
A total of 39 patients, 13 in each arm, will be randomized to inhaled steroid, leukotriene
receptor antagonist or placebo and followed for 18 months for changes in T-cell
costimulatory pathways.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
;
Time Perspective: Retrospective
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