Pharmacokinetics and dose-ranging of tiotropium inhalation solution delivered from the Respimat inhaler in patients with Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Chronic obstructive pulmonary disease (COPD)MedDRA version: 14.0Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
- Registration Number
- EUCTR2009-016251-21-BE
- Lead Sponsor
- SCS Boehringer Ingelheim Comm.V
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
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
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 Main Objective: To characterise the pharmacokinetics (systemic exposure to tiotropium) of once-daily tiotropium administered from the Respimat inhaler in doses of 1.25mcg, 2.5mcg and 5 mcg solution for inhalation and compare to tiotropium administered from the HandiHaler at a dose of 18 mcg inhalation powder following 4-week treatment periods.;Secondary Objective: To compare the safety (Holter ECG monitoring) and efficacy (FEV1, FVC) of tiotropium, 1.25mcg, 2.5mcg and 5mcg when administered as a solution for inhalation from the Respimat inhaler and as an inhalation powder (18mcg) from the HandiHaler.;Primary end point(s): The primary endpoints are Cmax,ss (maximum measured concentration of tiotropium in plasma at steady-state) AUC 0-6,ss (Area under the concentration time curve of tiotropium in plasma over the time interval 0 to 6 hours after inhalation at steady-state).<br><br>
- Secondary Outcome Measures
Name Time Method