Pulmonary Disease, Chronic ObstructivePhase 3NCT02182635
Ba253BINEB in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Ba253BINEB in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
The objective of this study is to investigate the long-term safety of Ba253BINEB. Secondarily the long-term efficacy of Ba253BINEB is also investigated. 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?
- Ba253BINEB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Aug 1998to Mar 1999
- 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
Who may be able to join
- The patients with COPD (chronic bronchitis, emphysema) and who satisfy the following criteria
- Patients with FEV1.0/FVC (Forced vital capacity) of <= 70% in the screening test and whose symptoms are stable
- Patients aged >= 40 years or older
- Patients must be able to understand the patient information form
Who cannot join
- Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
- Patients who have taken an long acting corticosteroids(i.m.) within 1 month before the study
- Patients using oral corticosteroid medication at a dose in excess of the equivalent 5 mg/day of prednisolone
- Patients with glaucoma
- Patients who have prostatic hypertrophy
- Patients with hypersensitivity to anticholinergic drugs
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- Patients with serious hepatic disease, kidney disease or heart disorder and who are judged by the investigator as inappropriate as the subjects of study
- Women who are pregnant or who may become pregnant, or nursing women
- Patients who are judged by the investigator as inappropriate as the subjects of the study
About this study
Official title: A Phase III Long-term Study of Ba253BINEB in Patients With COPD
The objective of this study is to investigate the long-term safety of Ba253BINEB. Secondarily the long-term efficacy of Ba253BINEB is also investigated.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Ba253BINEB
- 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.
Ba253BINEBDrug
| Study group | Role | What they receive |
|---|---|---|
| Ba253BINEB | Experimental | Not described Receives: Drug: Ba253BINEB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Adverse Events
Measured: Up to 28 weeks
Number of patients with significant changes from baseline in vital signs (blood pressure, heart rate)
Measured: Baseline, up to week 28
Number of patients with abnormal changes from baseline in electrocardiogram (ECG)
Measured: Baseline, up to week 28
Number of patients wiht abnormal changes from baseline in laboratory tests
Measured: Baseline, up to week 28
Secondary outcomes (5)
Change from baseline in FEV1 (Forced expiratory volume in one second)
Measured: Baseline, up to week 28
Change from baseline in COPD symptom scoring (cough, sputum amount, shortness of breath, nocturnal sleep)
Measured: Baseline, up to week 28
Physician's global evaluation (overall improvement)
Measured: Up to week 28
Patient's impression
Measured: Week 28
Physician's global evaluation (final improvement)
Measured: Week 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startAug 1998
- Primary completionMar 1999
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182635
- Sponsor's protocol ID
- 54.561
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 11 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Long-term Study of Ba253BINEB in Patients With COPD
- ClinicalTrials.gov ID
- NCT02182635
- Acronym / sponsor ID
- 54.561
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Aug 1998
- Primary completion
- Mar 1999 (actual)
- First posted
- 8 Jul 2014 (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 objective of this study is to investigate the long-term safety of Ba253BINEB. Secondarily the long-term efficacy of Ba253BINEB is also investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ba253BINEB | Experimental | Drug: Ba253BINEB |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The patients with COPD (chronic bronchitis, emphysema) and who satisfy the following criteria
- Patients with FEV1.0/FVC (Forced vital capacity) of <= 70% in the screening test and whose symptoms are stable
- Patients aged >= 40 years or older
- Patients must be able to understand the patient information form
Key exclusion criteria (9 listed)
- Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
- Patients who have taken an long acting corticosteroids(i.m.) within 1 month before the study
- Patients using oral corticosteroid medication at a dose in excess of the equivalent 5 mg/day of prednisolone
- Patients with glaucoma
- Patients who have prostatic hypertrophy
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 |
|---|---|---|
| Ba253BINEB | Drug | Ba253BINEB |
Primary outcome
Number of Patients with Adverse Events
Time frame: Up to 28 weeks
Number of patients with significant changes from baseline in vital signs (blood pressure, heart rate)
Time frame: Baseline, up to week 28
Number of patients with abnormal changes from baseline in electrocardiogram (ECG)
Time frame: Baseline, up to week 28
Number of patients wiht abnormal changes from baseline in laboratory tests
Time frame: Baseline, up to week 28
5 secondary outcomes
Change from baseline in FEV1 (Forced expiratory volume in one second)
Time frame: Baseline, up to week 28
Change from baseline in COPD symptom scoring (cough, sputum amount, shortness of breath, nocturnal sleep)
Time frame: Baseline, up to week 28
Physician's global evaluation (overall improvement)
Time frame: Up to week 28
Patient's impression
Time frame: Week 28
Physician's global evaluation (final improvement)
Time frame: Week 28
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 11 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ba253BINEB in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
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 4 inclusion and 9 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 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of Patients with Adverse Events (time frame: Up to 28 weeks). The study lists 4 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 11 Jul 2014.