[New approaches to evaluation of nonspecific inhalation provocation (dose-response relationship) in the comparative evaluation of bronchial hyperreactivity within the scope of clinical trials].
For the performance of clinical drug trials in the therapy for bronchial hyperresponsiveness, unspecific inhalatory provocation tests are generally employed to judge therapeutic success. In particular, the parameter-specific provocation doses are considered to be the main target values. However, it must be considered that these provocation doses are not equally calculable for every patient in the same way and at any examination time. This leads to the fact that the number of evaluable case studies is often appreciably lower than the number of test participants and that a meaningful therapy group comparison may even not be possible under certain circumstances. An evaluation model is presented here in order to fully exploit the obtained data; in this the percentile changes of the function parameters (estimated by linear regression) at a defined dose of the provocation substance are analyzed. In analogy, a survival time model and, as a supplement, a best case/worst case analysis are performed for further statistical evaluation. With the present procedure, an evaluation with inclusion of all test participants is possible. In contrast to the previously used evaluation procedures, this allows a reliable statistical confirmation of the results of clinical tests in the therapy for bronchial hyperresponsiveness.
Schlegel
J
J
III. Medizinische Klinik und Poliklinik-Schwerpunkt Pneumologie, Universitätsklinik Mainz.
Meng
G
G
Kieser
M
M
Lorenz
J
J
Kienast
K
K
Ferlinz
R
R
D000336:Aerosols; D000403:Airway Resistance / Q000187:drug effects; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy*; D016535:Bronchial Hyperreactivity / Q000175:diagnosis / Q000188:drug therapy*; D001985:Bronchial Provocation Tests / Q000379:methods*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D006801:Humans; D016210:Methacholine Chloride
D000336:Aerosols; D016210:Methacholine Chloride
Neue Ansätze zur Auswertung der unspezifischen inhalativen Provokation (Dosis-Wirkungs-Beziehung) zur vergleichenden Bewertung der bronchialen Hyperreagibilität im Rahmen der Durchführung klinischer Arzneimittelprüfungen.