Tiotropium Respimat Pharmacokinetic Study in COPD

Boehringer Ingelheim

Status and phase: Completed; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Tiotropium 18mcg; Drug: Tiotropium medium; Drug: Tiotropium low; Drug: Tiotropium high; Drug: Tiotropium placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01222533

2009-016251-21 (EudraCT Number)

205.458

Details and patient eligibility

About

The purpose of this study is compare the effect of different doses of tiotropium delivered by the HandiHaler and Respimat device on lung function. Additionally, the study will investigate the pharmacokinetic profile of these different doses. Studying the pharmacokinetic profile shows what happens to the medication in the body over a period of hours and provides information on potential effects of the medication.

Enrollment: 154 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. All patient must sign an informed consent consistent with IInternational Conference on Harmonisation- Good Clinical Practice (ICH-GCP) guidelines and local legislation prior to any study-related procedures, including medication washout and restrictions.
2. Relatively stable, moderate to very severe Chronic Obstructive Pulmonary Disease (COPD)
3. Current or ex-smokers (smoking history of at least 10 pack years)
4. Able to perform lung function tests
5. Able to use study inhalers

Exclusion criteria

1. Significant diseases other than COPD

2. Recent myocardial infarction, unstable or life-threatening cardiac arrhythmia, hospitalisation for cardiac failure.

3. Malignancy requiring resection, radiation therapy or chemotherapy within the last 5 years

4. History of asthma, life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis 5 Active tuberculosis

5. History of alcohol or drug abuse 7. Pulmonary resection 8. Recent completion of a pulmonary rehabilitation program or current participation which will not be continued 9. Daytime oxygen therapy for more than 1 hour per day. 10. Use of other investigational drugs, restrictions on the use of some respiratory medications during the study period.

6. Current participation in another clinical trial 12. Pregnant or nursing women 13. Women of childbearing potential not using a highly effective method of contraception (e.g: implants, injectable, oral contraceptives)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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154 participants in 5 patient groups, including a placebo group

Tiotropium low

Experimental group

Description:

Tiotropium inhalation solution low dose

Treatment:

Drug: Tiotropium low

Tiotropium medium

Experimental group

Description:

Tiotropium inhalation solution medium dose

Treatment:

Drug: Tiotropium medium

Tiotropium high

Experimental group

Description:

Tiotropium inhalation solution high dose

Treatment:

Drug: Tiotropium high

Tiotropium 18mcg

Active Comparator group

Description:

Tiotropium inhalation powder 18mcg

Treatment:

Drug: Tiotropium 18mcg

Tiotropium placebo

Placebo Comparator group

Description:

Placebo inhalation solution

Treatment:

Drug: Tiotropium placebo