Pulmonary Disease, Chronic ObstructivePhase 4NCT00152984
Efficacy and Safety of Tiotropium in Patients With COPD and Concomitant Diagnosis of Asthma
A Phase 4 study testing Tiotropium inhalation capsules in people with Pulmonary Disease, Chronic Obstructive and Asthma, run by Boehringer Ingelheim at 68 sites in 8 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Asthma
- What is being tested?
- Tiotropium inhalation capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 472 participants
- Where
- 68 sitesin 8 countries
- Study dates
- Dec 2004to Apr 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
68 sites in 8 countries.
68 sites in 8 countries
Germany14 sites
Boehringer Ingelheim Investigational Site
Berlin, 12203
Boehringer Ingelheim Investigational Site
Berlin, 12687
MEDARS GmbH
Berlin, 14057
Boehringer Ingelheim Investigational Site
Bonn, 53119
Med. Einrichtung der Universitat zu Koln
Cologne, 50924
Boehringer Ingelheim Investigational Site
Frankfurt am Main, 60323
Boehringer Ingelheim Investigational Site
Fürth, 90762
Inamed Research GmbH & Co. KG
Gauting, 82131
Boehringer Ingelheim Investigational Site
Gelnhausen, 63571
ClinPharm Internat. GmbH & Co. KG
Görlitz, 02826
Pneumologisches Forschungsinstitut GmbH am Krankenhaus
Hamburg, 20535
Boehringer Ingelheim Investigational Site
Minden, 32423
Boehringer Ingelheim Investigational Site
München, 80335
Boehringer Ingelheim Investigational Site
Rüdersdorf, 15562
France12 sites
Hopital d'Annecy
Annecy, 74000
Hopital Prive Antony
Antony, 92166
Boehringer Ingelheim Investigational Site
Chamalières, 66400
Hopital Gabriel Montpied
Clermont-Ferrand, 63003
Hopital Ambroise Pare
Marseille, 13291
Hopital Notre Dame de Bon Secours
Metz, 57038
Boehringer Ingelheim Investigational Site
Montpellier, 34070
Hopital Arnaud de Villeneuve
Montpellier, 34295
Boehringer Ingelheim Investigational Site
Nantes, 44000
Centre Medical Erdre St Augustin
Nantes, 44000
Boehringer Ingelheim Investigational Site
Nice, 06000
Hopital Maison blanche
Reims, 51092
Canada10 sites
Department of Medicine, Health Sciences Centre
Hamilton, Ontario, L8N 3Z5
Boehringer Ingelheim Investigational Site
Mississauga, Ontario, L5B 1N1
Centre de Recherche Clinique -CUSE
Sherbrooke, Quebec, J1H 5N4
Hopital Laval
Ste-Foy, Quebec, G1V 4G5
Boehringer Ingelheim Investigational Site
Toronto, Ontario, M5S 2A5
Respiratory Research Lab
Toronto, Ontario, M5T 2S8
Boehringer Ingelheim Investigational Site
Toronto, Ontario, M6H 3M2
Department of Respiratory Medicine
Toronto, Ontario, M6M 2J5
VGH Research Pavillion
Vancouver, British Columbia, V5Z 1L8
BG 034, Room C2027
Winnipeg, Manitoba, R2H 2A6
South Africa8 sites
Boehringer Ingelheim Investigational Site
Bellville, 7530
Boehringer Ingelheim Investigational Site
Cape Town, 7700
Boehringer Ingelheim Investigational Site
Cape Town, 8001
Boehringer Ingelheim Investigational Site
Durban, 4001
Boehringer Ingelheim Investigational Site
George, 6529
Boehringer Ingelheim Investigational Site
Paarl, 7646
Boehringer Ingelheim Investigational Site
Pretoria, 0001
Boehringer Ingelheim Investigational Site
Somerset West, 7130
Belgium7 sites
CHU Sart Tilman
Angleur, 4031
A.Z. VUB
Brussels, 1090
Boehringer Ingelheim Investigational Site
Genk, 3600
Boehringer Ingelheim Investigational Site
Hasselt, 3500
St. Elisabethziekenhuis
Herentals, 2200
Clinique Reine Astrid
Malmedy, 4960
Sint-Elisabethziekenhuis
Turnhout, 2300
Netherlands7 sites
Ziekenhuisgroep Twent
Almelo, 7609 PP
Amphia ziekenhuis
Breda, 4819 EV
Atrium medisch centrum
Heerlen, 6419 PC
Ziekenhuigroep Twente
Hengelo, 7555 DL
Medisch Centrum Leeuwarden
Leeuwarden, 8934 AD
Antonius Ziekenhuis
Sneek, 8601 ZK
Maxima Medisch Centrum
Velthoven, 5505 DB
Denmark6 sites
Lungemedicinsk Forskning 2B
Aarhus, DK-8000
Lungemedicinsk afdeling Y
Hellerup, 2900
Medicinsk afdeling B0642
Hiller?d, 3400
Lungemedicinsk Klinik
Hvidovre, DK-2650
H:S Bispebjerg Hospital
K?benhavn NV, 2400
Lungemedicinsk Forskning
Odense C, 5000
Italy4 sites
A. O. Universitaria di Ferrara - Arcispedale S. Anna
Ferrara, 44100
A.O. S. Martino e Cliniche Universitarie di Genova
Genova, 16132
Universita di Genova
Genova, 16132
A.O. Pisana
Pisa, 56100
About this study
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
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
- Conditions
- Pulmonary Disease, Chronic Obstructive, Asthma
- Being tested
- Tiotropium inhalation capsules, Placebo inhalation capsules
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiotropium inhalation capsulesDrug
Placebo inhalation capsulesDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-6) FEV1 (Area under the curve of change in FEV1 from baseline to 6 hours post dose)
Measured: after 12 weeks of treatment
Secondary outcomes (14)
Forced vital capacity (FVC)
Measured: 12 weeks
Peak expiratory flow rate (PEFR)
Measured: 12 weeks
Use of rescue medication
Measured: 12 weeks
AUC0-6hFEV1
Measured: after first dose on Day 1 and after 4 weeks of treatment
Change in trough FEV1 (i.e. trough response) from baseline.
Measured: after 4 and 12 weeks of treatment
Change in peak FEV1 from baseline (=peak response) after first dose
Measured: after 4 and 12 weeks of treatment
AUC0-6hFVC defined in the same way as for FEV1.
Measured: Day 1, week 4
Trough FVC defined in the same way as for FEV1.
Measured: Day 1, week 4
Peak FVC defined in the same way as for FEV1
Measured: Day 1, week 4
Weekly average PEFR in the morning (a.m. pre-dose measurement) and in the evening (p.m. measurement).
Measured: 12 weeks
Weekly average number of puffs of rescue medication used
Measured: 12 weeks
Occurrence of adverse events
Measured: 12 weeks
Change from baseline in pulse rate and systolic and diastolic blood pressure (seated) measured just before spirometry
Measured: 12 weeks
Change from baseline in Physical examination
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionApr 2006
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 472 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, B.I. Pharma GmbH & Co. KG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152984
- Sponsor's protocol ID
- 205.301
- Status last verified
- Dec 2017
- First submitted
- 8 Sep 2005
- Last updated
- 28 Dec 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00152984
- Acronym / sponsor ID
- 205.301
- Conditions
- Pulmonary Disease, Chronic Obstructive, Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 472 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tiotropium inhalation capsules | Drug | – |
| Placebo inhalation capsules | Drug | – |
Primary outcome
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
14 secondary outcomes
Forced vital capacity (FVC)
Time frame: 12 weeks
Peak expiratory flow rate (PEFR)
Time frame: 12 weeks
Use of rescue medication
Time frame: 12 weeks
AUC0-6hFEV1
Time frame: 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
Change in peak FEV1 from baseline (=peak response) after first dose
Time frame: after 4 and 12 weeks of treatment
AUC0-6hFVC defined in the same way as for FEV1.
Time frame: Day 1, week 4
Trough FVC defined in the same way as for FEV1.
Time frame: Day 1, week 4
Peak FVC defined in the same way as for FEV1
Time frame: 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
Weekly average number of puffs of rescue medication used
Time frame: 12 weeks
Occurrence of adverse events
Time frame: 12 weeks
Change from baseline in pulse rate and systolic and diastolic blood pressure (seated) measured just before spirometry
Time frame: 12 weeks
Change from baseline in Physical examination
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
Related trials for Pulmonary Disease, Chronic Obstructive
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim Study Coordinator study chair
B.I. Pharma GmbH & Co. KG
68 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tiotropium inhalation capsules in people with Pulmonary Disease, Chronic Obstructive and Asthma, run by Boehringer Ingelheim at 68 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 68 sites in Germany, France, Canada, South Africa, Belgium and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2017.