Pharmacokinetics and dose-ranging of tiotropium inhalation solution delivered from the Respimat inhaler in patients with Chronic Obstructive Pulmonary Disease (COPD)

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 160

Inclusion Criteria

1. All patients must sign an informed consent consistent with ICH-GCP guidelines
and local legislations prior to any study-related procedures, which includes
medication washout and restrictions.

2. Male or female patients 40 years of age or older.

3. Patients must be current or ex-smokers with a smoking history of = 10 pack-
years (patients who have never smoked cigarettes must be excluded).

4. All patients must have a diagnosis of COPD and must meet the following criteria:
Relatively stable airway obstruction with a post-bronchodilator FEV1 < 80% of
predicted normal and post-bronchodilator FEV1 < 70% of post-bronchodilator
FVC.

5. Patients must be able to perform technically acceptable pulmonary function tests
during the study period as required in the protocol.

6. Patients must be able to inhale medication in a competent manner from the
HandiHaler and Respimat devices.

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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Significant diseases other than COPD.

2. Patients with a recent history (i.e., six months or less) of myocardial infarction.

3. Patients with any unstable or life-threatening cardiac arrhythmia requiring
intervention or change in drug therapy during the past year.

4. Hospitalisation for cardiac failure during the past year.

5. Malignancy for which the patient has undergone resection, radiation therapy or
chemotherapy within the last five years. Patients with treated basal cell
carcinoma are allowed.

6. Patients with a history of asthma or who have a total blood eosinophil count
greater than 600/mm3.

7. Patients with a history of life threatening pulmonary obstruction, or a history of
cystic fibrosis or clinically evident bronchiectasis.

8. Known active tuberculosis.

9. Patients with a history (within the past two years) of and / or active significant
alcohol or drug abuse.

10. Patients who have undergone thoracotomy with pulmonary resection.

11. Patients who have completed a pulmonary rehabilitation program in the six
weeks prior to screening or patients who are currently in a pulmonary
rehabilitation program that will not be maintained throughout the duration of
the study.

12. Patients who regularly use daytime oxygen therapy for more than 1 hour per
day and in the investigator’s opinion will be unable to abstain from the use of
oxygen therapy.

13. Patients who have taken an investigational drug during the four week period
prior to screening.

14. Use of antihistamines (H1 receptor antagonists), anti-leukotrienes or
leukotriene receptor antagonists for asthma or excluded allergic conditions.

15. Use of cromolyn sodium or nedocromil sodium.

16. Use of systemic corticosteroid medication at unstable doses.

17. Known hypersensitivity to anticholinergic drugs, ß2-adrenergic drugs, lactose
or any other component of the study medication delivery systems.

18. Pregnant or nursing women

19. Women of childbearing potential not using a highly effective method of birth
control.

20. Treatment with oral beta-adrenergics within 4 weeks prior to screening or
during the run-in period.

21. Treatment with indacaterol.

22. Treatment with tiotropium within 2 weeks prior to screening and within 3
weeks prior to randomisation.

23. Treatment with theophylline within specified time windows prior to screening.

24. Patients who are currently participating in another study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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