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Efficacy and Safety of Tiotropium in Patients With COPD and Concomitant Diagnosis of Asthma

Primary Purpose

Pulmonary Disease, Chronic Obstructive, Asthma

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Tiotropium inhalation capsules
Placebo inhalation capsules
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Sart Tilman
  • A.Z. VUB
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • St. Elisabethziekenhuis
  • Clinique Reine Astrid
  • Sint-Elisabethziekenhuis
  • VGH Research Pavillion
  • BG 034, Room C2027
  • Department of Medicine, Health Sciences Centre
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Respiratory Research Lab
  • Boehringer Ingelheim Investigational Site
  • Department of Respiratory Medicine
  • Centre de Recherche Clinique -CUSE
  • Hopital Laval
  • Lungemedicinsk Forskning 2B
  • Lungemedicinsk afdeling Y
  • Medicinsk afdeling B0642
  • Lungemedicinsk Klinik
  • H:S Bispebjerg Hospital
  • Lungemedicinsk Forskning
  • Hopital d'Annecy
  • Hopital Prive Antony
  • Boehringer Ingelheim Investigational Site
  • Hopital Gabriel Montpied
  • Hopital Ambroise Pare
  • Hopital Notre Dame de Bon Secours
  • Boehringer Ingelheim Investigational Site
  • Hopital Arnaud de Villeneuve
  • Boehringer Ingelheim Investigational Site
  • Centre Medical Erdre St Augustin
  • Boehringer Ingelheim Investigational Site
  • Hopital Maison blanche
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • MEDARS GmbH
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Inamed Research GmbH & Co. KG
  • Boehringer Ingelheim Investigational Site
  • ClinPharm Internat. GmbH & Co. KG
  • Pneumologisches Forschungsinstitut GmbH am Krankenhaus
  • Med. Einrichtung der Universitat zu Koln
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • A. O. Universitaria di Ferrara - Arcispedale S. Anna
  • A.O. S. Martino e Cliniche Universitarie di Genova
  • Universita di Genova
  • A.O. Pisana
  • Ziekenhuisgroep Twent
  • Amphia ziekenhuis
  • Atrium medisch centrum
  • Ziekenhuigroep Twente
  • Medisch Centrum Leeuwarden
  • Antonius Ziekenhuis
  • Maxima Medisch Centrum
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site

Outcomes

Primary Outcome Measures

AUC(0-6) FEV1 (Area under the curve of change in FEV1 from baseline to 6 hours post dose)

Secondary Outcome Measures

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

Full Information

First Posted
September 8, 2005
Last Updated
December 27, 2017
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00152984
Brief Title
Efficacy and Safety of Tiotropium in Patients With COPD and Concomitant Diagnosis of Asthma
Official Title
A 12-week Randomised, Double Blind, Placebo Controlled, Parallel Group Trial Evaluating the Efficacy and Safety of Inhaled Tiotropium 18μg q.d. in Patients With COPD and a Concomitant Diagnosis of Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
The primary objective of this study is to demonstrate the superiority of tiotropium compared to placebo in the treatment of patients with COPD and a concomitant diagnosis of asthma

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
472 (false)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
B.I. Pharma GmbH & Co. KG
Official's Role
Study Chair
Facility Information:
Facility Name
CHU Sart Tilman
City
Angleur
ZIP/Postal Code
4031
Country
Belgium
Facility Name
A.Z. VUB
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Boehringer Ingelheim Investigational Site
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Boehringer Ingelheim Investigational Site
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
St. Elisabethziekenhuis
City
Herentals
ZIP/Postal Code
2200
Country
Belgium
Facility Name
Clinique Reine Astrid
City
Malmedy
ZIP/Postal Code
4960
Country
Belgium
Facility Name
Sint-Elisabethziekenhuis
City
Turnhout
ZIP/Postal Code
2300
Country
Belgium
Facility Name
VGH Research Pavillion
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L8
Country
Canada
Facility Name
BG 034, Room C2027
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
Department of Medicine, Health Sciences Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B 1N1
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 2A5
Country
Canada
Facility Name
Respiratory Research Lab
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M2
Country
Canada
Facility Name
Department of Respiratory Medicine
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6M 2J5
Country
Canada
Facility Name
Centre de Recherche Clinique -CUSE
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Hopital Laval
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Lungemedicinsk Forskning 2B
City
Aarhus
ZIP/Postal Code
DK-8000
Country
Denmark
Facility Name
Lungemedicinsk afdeling Y
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Medicinsk afdeling B0642
City
Hiller?d
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Lungemedicinsk Klinik
City
Hvidovre
ZIP/Postal Code
DK-2650
Country
Denmark
Facility Name
H:S Bispebjerg Hospital
City
K?benhavn NV
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Lungemedicinsk Forskning
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Hopital d'Annecy
City
Annecy
ZIP/Postal Code
74000
Country
France
Facility Name
Hopital Prive Antony
City
Antony cedex
ZIP/Postal Code
92166
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Chamalieres
ZIP/Postal Code
66400
Country
France
Facility Name
Hopital Gabriel Montpied
City
Clermont Ferrand cedex 1
ZIP/Postal Code
63003
Country
France
Facility Name
Hopital Ambroise Pare
City
Marseille
ZIP/Postal Code
13291
Country
France
Facility Name
Hopital Notre Dame de Bon Secours
City
Metz cedex 1
ZIP/Postal Code
57038
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Montpellier
ZIP/Postal Code
34070
Country
France
Facility Name
Hopital Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Centre Medical Erdre St Augustin
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Hopital Maison blanche
City
Reims cedex
ZIP/Postal Code
51092
Country
France
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Berlin
ZIP/Postal Code
12687
Country
Germany
Facility Name
MEDARS GmbH
City
Berlin
ZIP/Postal Code
14057
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Bonn
ZIP/Postal Code
53119
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Frankfurt/Main
ZIP/Postal Code
60323
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Furth
ZIP/Postal Code
90762
Country
Germany
Facility Name
Inamed Research GmbH & Co. KG
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Gelnhausen
ZIP/Postal Code
63571
Country
Germany
Facility Name
ClinPharm Internat. GmbH & Co. KG
City
Gorlitz
ZIP/Postal Code
02826
Country
Germany
Facility Name
Pneumologisches Forschungsinstitut GmbH am Krankenhaus
City
Hamburg
ZIP/Postal Code
20535
Country
Germany
Facility Name
Med. Einrichtung der Universitat zu Koln
City
Koln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Minden
ZIP/Postal Code
32423
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Munchen
ZIP/Postal Code
80335
Country
Germany
Facility Name
Boehringer Ingelheim Investigational Site
City
Rudersdorf
ZIP/Postal Code
15562
Country
Germany
Facility Name
A. O. Universitaria di Ferrara - Arcispedale S. Anna
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
Facility Name
A.O. S. Martino e Cliniche Universitarie di Genova
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Universita di Genova
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
A.O. Pisana
City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
Ziekenhuisgroep Twent
City
Almelo
ZIP/Postal Code
7609 PP
Country
Netherlands
Facility Name
Amphia ziekenhuis
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
Atrium medisch centrum
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Facility Name
Ziekenhuigroep Twente
City
Hengelo
ZIP/Postal Code
7555 DL
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
ZIP/Postal Code
8934 AD
Country
Netherlands
Facility Name
Antonius Ziekenhuis
City
Sneek
ZIP/Postal Code
8601 ZK
Country
Netherlands
Facility Name
Maxima Medisch Centrum
City
Velthoven
ZIP/Postal Code
5505 DB
Country
Netherlands
Facility Name
Boehringer Ingelheim Investigational Site
City
Bellville
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Boehringer Ingelheim Investigational Site
City
Cape Town
ZIP/Postal Code
7700
Country
South Africa
Facility Name
Boehringer Ingelheim Investigational Site
City
Cape Town
ZIP/Postal Code
8001
Country
South Africa
Facility Name
Boehringer Ingelheim Investigational Site
City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Boehringer Ingelheim Investigational Site
City
George
ZIP/Postal Code
6529
Country
South Africa
Facility Name
Boehringer Ingelheim Investigational Site
City
Paarl
ZIP/Postal Code
7646
Country
South Africa
Facility Name
Boehringer Ingelheim Investigational Site
City
Pretoria
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Boehringer Ingelheim Investigational Site
City
Somerset West
ZIP/Postal Code
7130
Country
South Africa

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.301_U07-1000.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.301_literature.pdf
Description
Related Info
URL
https://www.ncbi.nlm.nih.gov/pubmed/17920256
Description
Related Info

Learn more about this trial

Efficacy and Safety of Tiotropium in Patients With COPD and Concomitant Diagnosis of Asthma

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