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Tiotropium Respimat Pharmacokinetic Study in COPD

NCT ID: NCT01222533

Last Updated: 2014-05-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Tiotropium low

Tiotropium inhalation solution low dose

Group Type EXPERIMENTAL

Tiotropium low

Intervention Type DRUG

Tiotropium inhalation solution low dose

Tiotropium medium

Tiotropium inhalation solution medium dose

Group Type EXPERIMENTAL

Tiotropium medium

Intervention Type DRUG

Tiotropium inhalation solution medium dose

Tiotropium high

Tiotropium inhalation solution high dose

Group Type EXPERIMENTAL

Tiotropium high

Intervention Type DRUG

Tiotropium inhalation solution high dose

Tiotropium 18mcg

Tiotropium inhalation powder 18mcg

Group Type ACTIVE_COMPARATOR

Tiotropium 18mcg

Intervention Type DRUG

Tiotropium inhalation powder 18mcg

Tiotropium placebo

Placebo inhalation solution

Group Type PLACEBO_COMPARATOR

Tiotropium placebo

Intervention Type DRUG

Placebo inhalation solution

Interventions

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Tiotropium medium

Tiotropium inhalation solution medium dose

Intervention Type DRUG

Tiotropium low

Tiotropium inhalation solution low dose

Intervention Type DRUG

Tiotropium high

Tiotropium inhalation solution high dose

Intervention Type DRUG

Tiotropium 18mcg

Tiotropium inhalation powder 18mcg

Intervention Type DRUG

Tiotropium placebo

Placebo inhalation solution

Intervention Type DRUG

Eligibility Criteria

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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

6\. 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.

11\. 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)
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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205.458.32003 Boehringer Ingelheim Investigational Site

Genk, , Belgium

Site Status

205.458.32001 Boehringer Ingelheim Investigational Site

Ghent, , Belgium

Site Status

205.458.32002 Boehringer Ingelheim Investigational Site

Hasselt, , Belgium

Site Status

205.458.45001 Boehringer Ingelheim Investigational Site

Copenhagen K, , Denmark

Site Status

205.458.45003 Boehringer Ingelheim Investigational Site

København NV, , Denmark

Site Status

205.458.45002 Boehringer Ingelheim Investigational Site

Odense C, , Denmark

Site Status

205.458.35801 Boehringer Ingelheim Investigational Site

Helsinki, , Finland

Site Status

205.458.35802 Boehringer Ingelheim Investigational Site

Tampere, , Finland

Site Status

205.458.49001 Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

205.458.31001 Atrium Medisch Centrum Parkstad

Heerlen, , Netherlands

Site Status

205.458.31002 Ommelander ziekenhuis groep, locatie Lucas

Winschoten, , Netherlands

Site Status

Countries

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Belgium Denmark Finland Germany Netherlands

References

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Hohlfeld JM, Furtwaengler A, Konen-Bergmann M, Wallenstein G, Walter B, Bateman ED. Cardiac safety of tiotropium in patients with COPD: a combined analysis of Holter-ECG data from four randomised clinical trials. Int J Clin Pract. 2015 Jan;69(1):72-80. doi: 10.1111/ijcp.12596. Epub 2014 Dec 11.

Reference Type DERIVED
PMID: 25496316 (View on PubMed)

Hohlfeld JM, Sharma A, van Noord JA, Cornelissen PJ, Derom E, Towse L, Peterkin V, Disse B. Pharmacokinetics and pharmacodynamics of tiotropium solution and tiotropium powder in chronic obstructive pulmonary disease. J Clin Pharmacol. 2014 Apr;54(4):405-14. doi: 10.1002/jcph.215. Epub 2013 Nov 27.

Reference Type DERIVED
PMID: 24165906 (View on PubMed)

Other Identifiers

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2009-016251-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

205.458

Identifier Type: -

Identifier Source: org_study_id

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