Pulmonary Disease, Chronic ObstructivePhase 3NCT02182583
Ba253BINEB Compared to Ba253MDI (Metered Dose Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Ba253MDI and Ba253BINEB in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
The objective of this study is to investigate the efficacy and safety of Ba253BINEB during the continuous 4 weeks administration to the patients with COPD using Ba253MDI (Tersigan® aerosol) as the comparator drug. 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?
- Ba253MDI and Ba253BINEB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- No sites listed yet
- Study dates
- Oct 1998to Jun 2000
- 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 whose symptoms are stable and have at least 4 symptomatic days a week
- Patients with FEV1.0/FVC of <= 70% in the screening test
- Patients aged >= 40 years or older
- Patients must be able to inhale the study drug via BINEB and MDI
- Patients must be able to understand the patient information form
Who cannot join
- Those who correspond to the following shall be excluded from the subjects of study.
- Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
- Patients who are constantly administered oral steroid
- Patients with glaucoma
- Patients who have prostatic hypertrophy
- Patients with hypersensitivity to anticholinergic drugs or Beta2 agonists.
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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 Study of Ba253BINEB in Patients With COPD - Double-blind, Randomised, Double Dummy, Multiple Dose Study in Comparison With MDI
The objective of this study is to investigate the efficacy and safety of Ba253BINEB during the continuous 4 weeks administration to the patients with COPD using Ba253MDI (Tersigan® aerosol) as the comparator drug.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Ba253MDI, 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.
Ba253MDIDrug
Also called Tersigan® aerosol
Ba253BINEBDrug
| Study group | Role | What they receive |
|---|---|---|
| Ba253BINEB | Experimental | Not described Receives: Drug: Ba253BINEB |
| Ba253MDI | Active comparator | Not described Receives: Drug: Ba253MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in COPD daily symptom scores
Measured: Baseline and up to 4 weeks after first drug administration
Secondary outcomes (12)
Change from baseline in times of cough
Measured: Baseline, up to 4 weeks after first drug administration
Change from baseline in peak expiratory flow rate (PEFR)
Measured: Baseline, up to 4 weeks after first drug administration
Number of Patients with Adverse Events
Measured: Up to 4 weeks
Number of patients with significant changes in vital sings (blood pressure, pulse rate)
Measured: Baseline, week 4
Number of patients with abnormal changes in electrocardiogram (ECG)
Measured: Baseline, week 4
Number of patients with abnormal changes in laboratory values
Measured: Baseline, week 4
Physician's global evaluation
Measured: 4 weeks after first drug administration
Patient's impression
Measured: 4 weeks after first drug administration
Change from baseline in times and volume of sputum
Measured: Baseline, up to 4 weeks after first drug administration
Change from baseline in transition of nocturnal sleep
Measured: Baseline, up to 4 weeks after first drug administration
Change from baseline in FEV1 (Forced expiratory volume in one second)
Measured: Baseline, week 4
Change from baseline in FVC (Forced vital capacity)
Measured: Baseline, week 4
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 startOct 1998
- Primary completionJun 2000
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
- 163 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
- NCT02182583
- Sponsor's protocol ID
- 54.560
- 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 Study of Ba253BINEB in Patients With COPD - Double-blind, Randomised, Double Dummy, Multiple Dose Study in Comparison With MDI
- ClinicalTrials.gov ID
- NCT02182583
- Acronym / sponsor ID
- 54.560
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 1998
- Primary completion
- Jun 2000 (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 efficacy and safety of Ba253BINEB during the continuous 4 weeks administration to the patients with COPD using Ba253MDI (Tersigan® aerosol) as the comparator drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ba253BINEB | Experimental | Drug: Ba253BINEB |
| Ba253MDI | Active comparator | Drug: Ba253MDI |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patients with COPD (chronic bronchitis, emphysema) and who satisfy the following criteria
- Patients whose symptoms are stable and have at least 4 symptomatic days a week
- Patients with FEV1.0/FVC of <= 70% in the screening test
- Patients aged >= 40 years or older
- Patients must be able to inhale the study drug via BINEB and MDI
Key exclusion criteria (9 listed)
- Those who correspond to the following shall be excluded from the subjects of study.
- Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
- Patients who are constantly administered oral steroid
- 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 |
|---|---|---|
| Ba253MDIAlso: Tersigan® aerosol | Drug | Ba253MDI |
| Ba253BINEB | Drug | Ba253BINEB |
Primary outcome
Change in COPD daily symptom scores
Time frame: Baseline and up to 4 weeks after first drug administration
12 secondary outcomes
Change from baseline in times of cough
Time frame: Baseline, up to 4 weeks after first drug administration
Change from baseline in peak expiratory flow rate (PEFR)
Time frame: Baseline, up to 4 weeks after first drug administration
Number of Patients with Adverse Events
Time frame: Up to 4 weeks
Number of patients with significant changes in vital sings (blood pressure, pulse rate)
Time frame: Baseline, week 4
Number of patients with abnormal changes in electrocardiogram (ECG)
Time frame: Baseline, week 4
Number of patients with abnormal changes in laboratory values
Time frame: Baseline, week 4
Physician's global evaluation
Time frame: 4 weeks after first drug administration
Patient's impression
Time frame: 4 weeks after first drug administration
Change from baseline in times and volume of sputum
Time frame: Baseline, up to 4 weeks after first drug administration
Change from baseline in transition of nocturnal sleep
Time frame: Baseline, up to 4 weeks after first drug administration
Change from baseline in FEV1 (Forced expiratory volume in one second)
Time frame: Baseline, week 4
Change from baseline in FVC (Forced vital capacity)
Time frame: Baseline, week 4
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.
- 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.
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 Ba253MDI and 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 6 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?
Change in COPD daily symptom scores (time frame: Baseline and up to 4 weeks after first drug administration). 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.