Pulmonary Disease, Chronic ObstructivePhase 2NCT00128440
High Dose Trial in COPD
A Phase 2 study testing BEA 2180 BR and tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 13 sites in United States.
Trial summary
The primary objective of this study was to compare the efficacy and safety of 200 μg and 400 μg of BEA 2180 BR to tiotropium 5 μg and placebo when each was delivered by the Respimat® Inhaler once daily for four weeks in patients with COPD. Read more about this study
- Who is it for?
- Ages 40 to 84 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- BEA 2180 BR and tiotropium
- How many people
- 78 participants
- Where
- 13 sitesUnited States
- Study dates
- Aug 2005to Sep 2006
- Phase
- Phase 2
- 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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 >=30% and <= 60% of predicted normal and FEV1 <=70% of FVC at the baseline PFTs at Visit 1 (at both timepoints).
- All patients must have an increase in FEV1 of at least 12% from baseline (th e -10 minute measurement) 45 min after inhalation of 80 ?g Atrovent MDI.
- Male or female patients 40 years of age or older.
- Smoker or ex-smoker with a history of more than 10 pack years.
- Patients with any other significant disease will be excluded. 2. Patients with a history of asthma or allergic rhinitis will be excluded.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Boehringer Ingelheim Investigational Site
Charleston, South Carolina
Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho
Boehringer Ingelheim Investigational Site
Harker Heights, Texas
Boehringer Ingelheim Investigational Site
Houston, Texas
Boehringer Ingelheim Investigational Site
Lakewood, California
Boehringer Ingelheim Investigational Site
Larchmont, New York
Boehringer Ingelheim Investigational Site
Pembroke Farms, Florida
Boehringer Ingelheim Investigational Site
Reno, Nevada
Boehringer Ingelheim Investigational Site
Richmond, Virginia
Boehringer Ingelheim Investigational Site
San Antonio, Texas
Boehringer Ingelheim Investigational Site
Tacoma, Washington
Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado
Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina
About this study
Official title: A Randomized, Multiple-dose, Double-Blind, Crossover Study to Compare the Efficacy and Safety of 200 μg and 400 μg of BEA 2180 BR to Tiotropium 5 μg and Placebo When Each is Delivered by the Respimat® Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The primary objective of this study was to compare the efficacy and safety of 200 μg and 400 μg of BEA 2180 BR to tiotropium 5 μg and placebo when each was delivered by the Respimat® Inhaler once daily for four weeks in patients with COPD.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- BEA 2180 BR, tiotropium
- 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.
BEA 2180 BRDrug
tiotropiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough forced expiratory volume (FEV1) response
Measured: baseline to 24 hours post drug administration
forced expiratory volume in one second (FEV1) area under curve 3 to 6 hours (AUC0-6h) after four weeks of treatment.
Measured: after 4 weeks
Secondary outcomes (11)
Trough FVC response after 4 weeks
Measured: after 4 weeks
FEV1 and FVC peak response after 0 and 4 weeks
Measured: after 0 and 4 weeks
FVC AUC0-6h after 0 and 4 weeks
Measured: after 0 and 4 weeks
Individual FEV1 and FVC measurements at each time point
Measured: 4 weeks
Weekly mean pre-dose morning and evening PEFR
Measured: 4 weeks
Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol]
Measured: 4 weeks
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest
Measured: 4 weeks
Physician's Global Evaluation
Measured: 4 weeks
All adverse events
Measured: 28 weeks
Pulse rate and blood pressure (seated) recorded in conjunction with spirometry for the first three hours following dosing
Measured: 28 weeks
12-lead ECGs at baseline (-10 minutes) and at 25 minutes, 2 and 6 hours post dose on Day 1 and 29 of each treatment period (Visits 2-9)
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2005 (estimated)
- Study startAug 2005
- Primary completionSep 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00128440
- Sponsor's protocol ID
- 1205.6
- Status last verified
- Oct 2013
- First submitted
- 9 Aug 2005
- Last updated
- 29 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multiple-dose, Double-Blind, Crossover Study to Compare the Efficacy and Safety of 200 μg and 400 μg of BEA 2180 BR to Tiotropium 5 μg and Placebo When Each is Delivered by the Respimat® Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00128440
- Acronym / sponsor ID
- 1205.6
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Primary completion
- Sep 2006 (actual)
- First posted
- 10 Aug 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 was to compare the efficacy and safety of 200 μg and 400 μg of BEA 2180 BR to tiotropium 5 μg and placebo when each was delivered by the Respimat® Inhaler once daily for four weeks in patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 84 years
- 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 |
|---|---|---|
| BEA 2180 BR | Drug | – |
| tiotropium | Drug | – |
Primary outcome
Trough forced expiratory volume (FEV1) response
Time frame: baseline to 24 hours post drug administration
forced expiratory volume in one second (FEV1) area under curve 3 to 6 hours (AUC0-6h) after four weeks of treatment.
Time frame: after 4 weeks
11 secondary outcomes
Trough FVC response after 4 weeks
Time frame: after 4 weeks
FEV1 and FVC peak response after 0 and 4 weeks
Time frame: after 0 and 4 weeks
FVC AUC0-6h after 0 and 4 weeks
Time frame: after 0 and 4 weeks
Individual FEV1 and FVC measurements at each time point
Time frame: 4 weeks
Weekly mean pre-dose morning and evening PEFR
Time frame: 4 weeks
Weekly mean number of occasions of rescue therapy used per day [as occasion requires (PRN) albuterol]
Time frame: 4 weeks
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest
Time frame: 4 weeks
Physician's Global Evaluation
Time frame: 4 weeks
All adverse events
Time frame: 28 weeks
Pulse rate and blood pressure (seated) recorded in conjunction with spirometry for the first three hours following dosing
Time frame: 28 weeks
12-lead ECGs at baseline (-10 minutes) and at 25 minutes, 2 and 6 hours post dose on Day 1 and 29 of each treatment period (Visits 2-9)
Time frame: 28 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 29 Oct 2013.
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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
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BEA 2180 BR and tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 13 sites in United States.
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 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 forced expiratory volume (FEV1) response (time frame: baseline to 24 hours post drug administration). The study lists 2 primary outcomes in all. 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 29 Oct 2013.