Pulmonary Disease, Chronic ObstructivePhase 3NCT00240435
12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD
A Phase 3 study testing 5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler and 10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 25 sites in 2 countries.
Trial summary
The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- 5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler and 10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler
- Type of treatment
- Medical device
- How many people
- 491 participants
- Where
- 25 sitesin 2 countries
- Study dates
- Nov 2002to Dec 2003
- Phase
- Phase 3
- 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
Outpatients of either sex, aged >/= 40 years with a diagnosis of COPD (FEV1 </= 60% predicted [ECCS criteria] and FEV1/FVC </= 70%)
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States14 sites
Boehringer Ingelheim Investigational Site
Bay Pines, Florida
Boehringer Ingelheim Investigational Site
Birmingham, Alabama
Boehringer Ingelheim Investigational Site
Charleston, South Carolina
Boehringer Ingelheim Investigational Site
Clearwater, Florida
Boehringer Ingelheim Investigational Site
Dallas, Texas
Boehringer Ingelheim Investigational Site
Downey, California
Boehringer Ingelheim Investigational Site
Elizabeth City, North Carolina
University of California - Los Angeles
Los Angeles, California
Boehringer Ingelheim Investigational Site
New Hyde Park, New York
Boehringer Ingelheim Investigational Site
Palo Alto, California
Boehringer Ingelheim Investigational Site
Pembroke Pines, Florida
Boehringer Ingelheim Investigational Site
St Louis, Missouri
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado
Boehringer Ingelheim Investigational Site
Wheaton, Maryland
Canada11 sites
Boehringer Ingelheim Investigational Site
Courtice, Ontario
St. Joseph's Hospital Cardiac Research
Hamilton, Ontario
SMBD--Jewish General Hospital
Montreal, Quebec
c/o Hemodynamics Offices
Saskatoon, Saskatchewan
Centre de Recherche Clinique -CUSE
Sherbrooke, Quebec
Hopital Laval
Ste-Foy, Quebec
Boehringer Ingelheim Investigational Site
Toronto, Ontario
Department of Respiratory Medicine
Toronto, Ontario
Toronto General Hospital
Toronto, Ontario
Boehringer Ingelheim Investigational Site
Vancouver, British Columbia
St. Boniface General Hospital
Winnipeg, Manitoba
About this study
Official title: A Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Comparison of 12-week Treatment of Two Doses (5 Mcg and 10 Mcg) of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) i
The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary objective was to compare the safety of tiotropium inhalation solution delivered by the Respimat to placebo and ipratropium bromide MDI.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- 5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler, 10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhalerDevice
10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhalerDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough FEV1 response after 12 weeks of treatment.
Measured: after 12 weeks
Secondary outcomes (19)
Trough FEV1 response
Measured: after 1, 4 and 8 weeks
Trough FVC response
Measured: after 1, 4, 8 and 12 weeks
FEV1 and FVC area under the curve and peak response
Measured: after 0, 1, 4, 8 and 12 weeks
Individual FEV1 and FVC measurements at each time point
Measured: during study course of 12 weeks
Therapeutic response and percentage of responders
Measured: after 0 and 12 weeks
Weekly mean pre-dose morning and evening PEFR
Measured: during study course of 12 weeks
Number of occasions of rescue therapy used per day (PRN salbutamol)
Measured: during study course of 12 weeks
COPD symptom scores
Measured: during 15 weeks
Physician's Global Evaluation
Measured: during 15 weeks
Number of patients with at least one exacerbation of COPD
Measured: 15 weeks
time to first exacerbation
Measured: 15 weeks
number of exacerbations
Measured: 15 weeks
number of exacerbation days
Measured: 15 weeks
Patient satisfaction and preference
Measured: 12 weeks
All adverse events
Measured: during 15 weeks, follow-up period included
Pulse rate and blood pressure for the first three hours following dosing
Measured: after 0, 1, 4, 8 and 12 weeks
Routine blood chemistry, haematology and urinalysis
Measured: after 12 weeks
12-lead ECG
Measured: after 12 weeks
Physical examination
Measured: after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startNov 2002
- Primary completionDec 2003
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 491 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240435
- Sponsor's protocol ID
- 205.252
- Status last verified
- Oct 2013
- First submitted
- 14 Oct 2005
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Comparison of 12-week Treatment of Two Doses (5 Mcg and 10 Mcg) of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) i
- ClinicalTrials.gov ID
- NCT00240435
- Acronym / sponsor ID
- 205.252
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 491 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Dec 2003 (actual)
- First posted
- 18 Oct 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 was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary objective was to compare the safety of tiotropium inhalation solution delivered by the Respimat to placebo and ipratropium bromide MDI.
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
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 |
|---|---|---|
| 5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler | Device | – |
| 10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler | Device | – |
Primary outcome
Trough FEV1 response after 12 weeks of treatment.
Time frame: after 12 weeks
19 secondary outcomes
Trough FEV1 response
Time frame: after 1, 4 and 8 weeks
Trough FVC response
Time frame: after 1, 4, 8 and 12 weeks
FEV1 and FVC area under the curve and peak response
Time frame: after 0, 1, 4, 8 and 12 weeks
Individual FEV1 and FVC measurements at each time point
Time frame: during study course of 12 weeks
Therapeutic response and percentage of responders
Time frame: after 0 and 12 weeks
Weekly mean pre-dose morning and evening PEFR
Time frame: during study course of 12 weeks
Number of occasions of rescue therapy used per day (PRN salbutamol)
Time frame: during study course of 12 weeks
COPD symptom scores
Time frame: during 15 weeks
Physician's Global Evaluation
Time frame: during 15 weeks
Number of patients with at least one exacerbation of COPD
Time frame: 15 weeks
time to first exacerbation
Time frame: 15 weeks
number of exacerbations
Time frame: 15 weeks
number of exacerbation days
Time frame: 15 weeks
Patient satisfaction and preference
Time frame: 12 weeks
All adverse events
Time frame: during 15 weeks, follow-up period included
Pulse rate and blood pressure for the first three hours following dosing
Time frame: after 0, 1, 4, 8 and 12 weeks
Routine blood chemistry, haematology and urinalysis
Time frame: after 12 weeks
12-lead ECG
Time frame: after 12 weeks
Physical examination
Time frame: after 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 1 Nov 2013.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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
Boehringer Ingelheim
25 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler and 10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 25 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Trough FEV1 response after 12 weeks of treatment. (time frame: after 12 weeks). 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 1 Nov 2013.