Influence of tiotropium bromide (Spiriva ®) plus salbutamol versus salbutamol on the mucin secretion and sputum properties in subjects with a COPD exacerbation-TIBROMUC- - TIBROMUC

Philipps-University Marburg0 个研究点开始时间: 2007年10月26日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•provided written informed consent
•Hospitalized male or female subjects’ = 35 years of age.
•Subject who has COPD 2 or 3 according to the GOLD criteria (see Table 1)
•FEV1/FVC < 70%
•30% <= FEV1 (GOLD 3) < 50% <= FEV1 (GOLD 2) < 80% predicted
•with chronic symptoms (cough, sputum production)
•Subjects must have a clinical diagnosis of an acute exacerbation of an underlying COPD (GOLD 2 and 3) supported by at least two of the following signs and symptoms: increased sputum purulence, increased dyspnea, or increased sputum volume (Anthonisen Criteria I or II).
•The onset of signs and symptoms of the current exacerbation must occur within 7 days before start of evaluation.
•Subjects may have taken inhaled anticholinergic- or ß2-agonists drugs prior to the study, except tiotropium bromide.
•Subjects may have taken inhaled corticosteroids (ICS) prior to the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

••Subjects who have taken tiotropium bromide in the last 4 weeks.
•Subjects should not have received any mucolytic drug such as acetylcysteine or ambroxol during the study and 24 hours prior to the study.
•Subjects who inhale corticosteroids during the time of study;
•whereas on the day and the day after evaluation inhaled corticosteroids are accepted.
•Subject who has suspected or known (positive chest radiograph) pneumonia.
•Subject who has suspected or known asthma bronchiale.
•Subject who requires parenteral antibiotic therapy.
•Subject who has taken:
•oA systemic antibiotic within 2 weeks before study drug administration
•oAny long acting antibiotic (e.g., penicillin G benzathine or azithromycin) within 4 weeks before study drug administration.
•Subject who has any other infection or condition, which necessitates use of a concomitant systemic antibiotic.
•Subject who has a severely compromised respiratory status (i.e., requires continuous oxygen).
•Pregnant or breast feeding women
•Subjects who are participating in any other clinical study

发起方

Philipps-University Marburg