Tiotropium inhalation capsules in Pulmonary Disease, Chronic Obstructive and Asthma - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

472

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Belgium
- - Angleur, Belgium, 4031
    - CHU Sart Tilman
  - Brussel, Belgium, 1090
    - A.Z. VUB
  - Genk, Belgium, 3600
    - Boehringer Ingelheim Investigational Site
  - Hasselt, Belgium, 3500
    - Boehringer Ingelheim Investigational Site
  - Herentals, Belgium, 2200
    - St. Elisabethziekenhuis
  - Malmedy, Belgium, 4960
    - Clinique Reine Astrid
  - Turnhout, Belgium, 2300
    - Sint-Elisabethziekenhuis
Canada
- British Columbia
  - Vancouver, British Columbia, Canada, V5Z 1L8
    - VGH Research Pavillion
- Manitoba
  - Winnipeg, Manitoba, Canada, R2H 2A6
    - BG 034, Room C2027
- Ontario
  - Hamilton, Ontario, Canada, L8N 3Z5
    - Department of Medicine, Health Sciences Centre
  - Mississauga, Ontario, Canada, L5B 1N1
    - Boehringer Ingelheim Investigational Site
  - Toronto, Ontario, Canada, M5S 2A5
    - Boehringer Ingelheim Investigational Site
  - Toronto, Ontario, Canada, M5T 2S8
    - Respiratory Research Lab
  - Toronto, Ontario, Canada, M6H 3M2
    - Boehringer Ingelheim Investigational Site
  - Toronto, Ontario, Canada, M6M 2J5
    - Department of Respiratory Medicine
- Quebec
  - Sherbrooke, Quebec, Canada, J1H 5N4
    - Centre de Recherche Clinique -CUSE
  - Ste-Foy, Quebec, Canada, G1V 4G5
    - Hopital Laval
Denmark
- - Aarhus, Denmark, DK-8000
    - Lungemedicinsk Forskning 2B
  - Hellerup, Denmark, 2900
    - Lungemedicinsk afdeling Y
  - Hiller?d, Denmark, 3400
    - Medicinsk afdeling B0642
  - Hvidovre, Denmark, DK-2650
    - Lungemedicinsk Klinik
  - K?benhavn NV, Denmark, 2400
    - H:S Bispebjerg Hospital
  - Odense C, Denmark, 5000
    - Lungemedicinsk Forskning
France
- - Annecy, France, 74000
    - Hôpital d'Annecy
  - Antony cedex, France, 92166
    - Hôpital Privé Antony
  - Chamalieres, France, 66400
    - Boehringer Ingelheim Investigational Site
  - Clermont Ferrand cedex 1, France, 63003
    - Hôpital Gabriel Montpied
  - Marseille, France, 13291
    - Hôpital Ambroise Paré
  - Metz cedex 1, France, 57038
    - Hôpital Notre Dame de Bon Secours
  - Montpellier, France, 34295
    - Hopital Arnaud de Villeneuve
  - Montpellier, France, 34070
    - Boehringer Ingelheim Investigational Site
  - Nantes, France, 44000
    - Boehringer Ingelheim Investigational Site
  - Nantes, France, 44000
    - Centre Medical Erdre St Augustin
  - Nice, France, 06000
    - Boehringer Ingelheim Investigational Site
  - Reims cedex, France, 51092
    - Hopital Maison Blanche
Germany
- - Berlin, Germany, 14057
    - MEDARS GmbH
  - Berlin, Germany, 12203
    - Boehringer Ingelheim Investigational Site
  - Berlin, Germany, 12687
    - Boehringer Ingelheim Investigational Site
  - Bonn, Germany, 53119
    - Boehringer Ingelheim Investigational Site
  - Frankfurt/Main, Germany, 60323
    - Boehringer Ingelheim Investigational Site
  - Furth, Germany, 90762
    - Boehringer Ingelheim Investigational Site
  - Gauting, Germany, 82131
    - Inamed Research GmbH & Co. KG
  - Gelnhausen, Germany, 63571
    - Boehringer Ingelheim Investigational Site
  - Gorlitz, Germany, 02826
    - ClinPharm Internat. GmbH & Co. KG
  - Hamburg, Germany, 20535
    - Pneumologisches Forschungsinstitut GmbH am Krankenhaus
  - Koln, Germany, 50924
    - Med. Einrichtung der Universitat zu Koln
  - Minden, Germany, 32423
    - Boehringer Ingelheim Investigational Site
  - Munchen, Germany, 80335
    - Boehringer Ingelheim Investigational Site
  - Rudersdorf, Germany, 15562
    - Boehringer Ingelheim Investigational Site
Italy
- - Ferrara, Italy, 44100
    - A. O. Universitaria di Ferrara - Arcispedale S. Anna
  - Genova, Italy, 16132
    - Università di Genova
  - Genova, Italy, 16132
    - A.O. S. Martino e Cliniche Universitarie di Genova
  - Pisa, Italy, 56100
    - A.O. Pisana
Netherlands
- - Almelo, Netherlands, 7609 PP
    - Ziekenhuisgroep Twent
  - Breda, Netherlands, 4819 EV
    - Amphia Ziekenhuis
  - Heerlen, Netherlands, 6419 PC
    - Atrium medisch centrum
  - Hengelo, Netherlands, 7555 DL
    - Ziekenhuigroep Twente
  - Leeuwarden, Netherlands, 8934 AD
    - Medisch Centrum Leeuwarden
  - Sneek, Netherlands, 8601 ZK
    - Antonius ziekenhuis
  - Velthoven, Netherlands, 5505 DB
    - Maxima Medisch Centrum
South Africa
- - Bellville, South Africa, 7530
    - Boehringer Ingelheim Investigational Site
  - Cape Town, South Africa, 7700
    - Boehringer Ingelheim Investigational Site
  - Cape Town, South Africa, 8001
    - Boehringer Ingelheim Investigational Site
  - Durban, South Africa, 4001
    - Boehringer Ingelheim Investigational Site
  - George, South Africa, 6529
    - Boehringer Ingelheim Investigational Site
  - Paarl, South Africa, 7646
    - Boehringer Ingelheim Investigational Site
  - Pretoria, South Africa, 0001
    - Boehringer Ingelheim Investigational Site
  - Somerset West, South Africa, 7130
    - Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

Diagnosis of COPD and diagnosis of asthma before the age of 30
Current or ex-smokers with a cigarette smoking history of at least 10 pack-years
Treatment with inhaled steroids at least 1 year before study entry
FEV1 increase of more than 12% 30 min. after 400 mcg salbutamol or documented reversibility of 12% documented during the past 5 years
FEV1 increase of more than 200 mL 30 min. after 400 mcg salbutamol or documented increase of 200 mL after reversibility test within the last 5 years
Post bronchodilator FEV1 less than 80% predicted normal (ECCS) at visit 1
Post bronchodilator FEV1 less than 70% of FVC at visit 1

Exclusion criteria:

Respiratory infection or exacerbation 6 weeks prior to Visit 1 or during run-in period.
Significant diseases other than COPD or asthma
Myocardial infarction within the last 6 months
Unstable or life-threatening cardiac arrhythmia requiring intervention or change in therapy in the last year
Hospitalisation for heart failure (NYHA Class III or IV) within the last year
History of life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
Known active tuberculosis
History of thoracotomy with pulmonary resection
History of cancer within the last 5 years (excluding treated basal cell carcinoma)
Patients requiring oxygen therapy for more than 1 hour per day
Patients currently in a pulmonary rehabilitation programme or who have completed such a programme within 4 weeks before Visit 1
Known hypersensitivity to anticholinergic drugs or lactose

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUC(0-6) FEV1 (Area under the curve of change in FEV1 from baseline to 6 hours post dose) Time Frame: after 12 weeks of treatment	after 12 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of adverse events Time Frame: 12 weeks	12 weeks
Use of rescue medication Time Frame: 12 weeks	12 weeks
Forced vital capacity (FVC) Time Frame: 12 weeks	12 weeks
Peak expiratory flow rate (PEFR) Time Frame: 12 weeks	12 weeks
AUC0-6hFEV1 Time Frame: after first dose on Day 1 and after 4 weeks of treatment	after first dose on Day 1 and after 4 weeks of treatment
Change in trough FEV1 (i.e. trough response) from baseline. Time Frame: after 4 and 12 weeks of treatment	after 4 and 12 weeks of treatment
Change in peak FEV1 from baseline (=peak response) after first dose Time Frame: after 4 and 12 weeks of treatment	after 4 and 12 weeks of treatment
AUC0-6hFVC defined in the same way as for FEV1. Time Frame: Day 1, week 4	Day 1, week 4
Trough FVC defined in the same way as for FEV1. Time Frame: Day 1, week 4	Day 1, week 4
Peak FVC defined in the same way as for FEV1 Time Frame: Day 1, week 4	Day 1, week 4
Weekly average PEFR in the morning (a.m. pre-dose measurement) and in the evening (p.m. measurement). Time Frame: 12 weeks	12 weeks
Weekly average number of puffs of rescue medication used Time Frame: 12 weeks	12 weeks
Change from baseline in pulse rate and systolic and diastolic blood pressure (seated) measured just before spirometry Time Frame: 12 weeks	12 weeks
Change from baseline in Physical examination Time Frame: 12 weeks	12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

April 1, 2006

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria