Anti-inflammatory effects of tiotropium in patients with stable COPD

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

•Men or women, age >= 40 years
•post-bronchodilator FEV1 >= 1.5 Litres
•smoking history of > 10 pack years.
•Being in a stable phase of COPD, as judged by the investigator. No courses of systemic steroids last 4 weeks
•Post-bronchodilator FEV1 / FVC ratio < 70% and post-bronchodilator FEV1 < 80%pred
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

•Treatment with long-acting anticholinerigcs <4 weeks before the start of the study.
•Treatment with corticosteroids <4 weeks before the start of the study.
•Concomitant diagnosis of asthma.
•Females of childbearing potential without an efficient contraception unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH >40 mIU/mL or the use of one or more of the following acceptable methods of contraception:
a) Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy).
b) Hormonal contraception (implantable, patch, oral, injectable).
c) Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository.
d) Continuous abstinence.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: A decrease of leukotriene B4 in induced sputum will be the main parameter for assessing the anti-inflammatory effects of 6 week treatment with tiotropium in patients with stable COPD;Secondary Objective: Additionally, changes in sputum cell differentials and other cytokine parameters (protein, mRNA), blood cell differentials, CRP, and cytokine parameters, health related quality of life (CCQ, CAT) will be assessed as well as changes in post-bronchdilator FEV1;Primary end point(s): The primary endpoint is leukotriene B4 decrease in induced sputum for assessing the anti-inflammatory effects of 6 week treatment with tiotropium in patients with stable COPD;Timepoint(s) of evaluation of this end point: Baseline and after treatment period of 6 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Changes in sputum cell differentials and other cytokine parameters (protein, mRNA), blood cell differentials, CRP, and cytokine parameters, health related quality of life (CCQ, CAT) will be assessed as well as changes in post-bronchdilator FEV1;Timepoint(s) of evaluation of this end point: Baseline and after treatment period of 6 weeks

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