LONG-TERM MULTICENTER TRIAL IN CHRONIC NONSPECIFIC LUNG-DISEASE - METHODOLOGY AND BASE-LINE ASSESSMENT IN ADULT PATIENTS

Autor: Paul Brand, Huib Kerstjens, Dirkje Postma, PJ STERK, PH QUANJER, HJ SLUITER, JH DIJKMAN, CLA VANHERWAARDEN, Hilvering, C., HM JANSEN, GH KOETER, Kreukniet, J.
Přispěvatelé: Groningen Research Institute for Asthma and COPD (GRIAC)
Jazyk: angličtina
Rok vydání: 1992
Předmět:
Zdroj: European Respiratory Journal, 5(1), 21-31. EUROPEAN RESPIRATORY SOC JOURNALS LTD
University of Groningen
ISSN: 0903-1936
Popis: Airways obstruction and airways hyperresponsiveness are two dominant features in patients with chronic nonspecific lung disease (asthma and chronic obstructive pulmonary disease (COPD)). We set up a study to determine whether long-term (3 yrs) therapeutic intervention directed at airways obstruction and hyperresponsiveness is superior to one directed at airways obstruction alone. Patients were selected on functional criteria (age, baseline forced expiratory volume in one second (FEV1), and airways hyperresponsiveness) and, furthermore, extensively characterized by history, smoking habits, allergy, reversibility of airways obstruction and quality of life. The methodology and practical problems of setting up this large multicentre study are outlined, together with an analysis of baseline data. Standardization of methods and techniques and recruitment of patients required much effort, recruitment taking about twice as long as expected. A 3 month feasibility study allowed us to eliminate minor problems in the protocol. Over a 16 month period, 274 adult patients (18-60 yrs) from the out-patient clinics of six university centres entered the study; 99 met the diagnostic criteria for asthma, 51 for COPD, 88 for asthmatic bron-chitis, and 36 could not be classified. Their mean (SD) FEV % pred was 65.1 (15.2)%. Their geometric mean provoking concentration of histamine producing a 20% fall in FEV1 (PC20 histamine) was 0.28 mg.ml-1. In a multiple regression analysis, more severe airways hyperresponsiveness was associated with lower prechallenge FEV % pred (p
Databáze: OpenAIRE