Anti-inflammatory effects of tiotropium in patients with stable COPD-A randomized controlled double-blind study

Phase 4

Recruiting

Conditions: Chronic obstructive pulmonary disease
COPD
10006436

Registration Number: NL-OMON55417

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

•Men or women, age >= 40 years
•post-bronchodilator FEV1 >= 0.8 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.

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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A decrease of the amount of interleukin-6 en interleukin-8 proteins in<br /><br>induced sputum will be the main parameter for assessing the anti-inflammatory<br /><br>effects of 6 week treatment with tiotropium in patients with stable COPD. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Additionally, changes in sputum cell differentials and other cytokine<br /><br>parameters (protein, mRNA,LTB4), blood cell differentials, CRP, and cytokine<br /><br>parameters, health related quality of life (CCQ, CAT) will be assessed as well<br /><br>as changes in post-bronchdilator FEV1.</p><br>