Pulmonary Disease, Chronic ObstructivePhase 3NCT02172807
Efficacy and Safety of Ba679BR Powder Inhalation in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Tiotropium low, Tiotropium high and Oxitropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
Study to investigate the efficacy and safety of Ba679BR powder inhalation during the continuous once/day administration to the patients with COPD using oxitropium bromide (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?
- Tiotropium low, Tiotropium high and Oxitropium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- No sites listed yet
- Study dates
- Dec 2000to Sep 2001
- 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
- Diagnosis of COPD (chronic bronchitis, and emphysema) with stable symptoms:
- Screening FEV1.0 ≤70% of predicted normal vale and screening FEV1.0/FVC ≤70% (the baseline FEV1.0 should also be ≤70% of predicted normal value on the initial day of administration)
- Smoking history ≥ 10 pack-years (a peak-year is 20 cigarettes per day for one year or equivalent)
- Male or female patients 40 years of age or older
Who cannot join
- History of bronchial asthma
- History of an atopic disease such as allergic rhinitis
- Total blood eosinophil count ≥ 600/µL
- Patient treated with antiallergic drugs or anti-histamine drugs
- Patients using oral corticosteroid medication at unstable doses (i.e. less than one month on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisolone per day
- Patients using inhaled steroid, oral β2 stimulant, theophylline preparation, expectorant or macrolide antibiotic at unstable doses (i.e. less than one month on a stable dose)
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- Patients using an ACE inhibitor at unstable doses (i.e. less than one month on a stable dose)
- Patients with known narrow-angle glaucoma
- Patients with known symptomatic prostatic hypertrophy
- Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system
- Patients with significant diseases who in the opinion of the investigator were not eligible for the study
- Patients with clinically significant abnormal baseline laboratory test values (hematology, blood chemistry, urinalysis). Patients with serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT) twice the upper limit of the normal range, bilirubin 150% or creatinine 125% of the upper limit of the normal range were excluded
- Patients with a recent history (i.e. within the 3 months prior to the screening visit) of myocardial infarction or heart failure
- Patients with any cardiac arrhythmia requiring drug therapy
- Patients who were treated with Patients who were treated with β-blockers-blockers
- Patients with regular use of daytime oxygen therapy
- Patients with known active tuberculosis or with obvious sequela of tuberculosis
- Patients with a history of cancer within the last 5 years. Patients with treated basal cell carcinoma were allowed
- Patients with a history of cystic fibrosis or bronchiectasis
- Patients with upper respiratory tract infection in the past one month prior to the screening visit or during the baseline period
- Patients who had taken an investigational drug within one month or six half lives (whichever is greater) prior to the screening visit
- Pregnant or nursing women or women of childbearing potential
- Other than the above, patients who in the opinion of the investigator were not eligible for the study
About this study
Official title: A Multiple Dose Comparison of 18 µg, 36 µg of Ba679BR (Tiotropium) Inhalation Capsules and Oxitropium Metered Dose Inhaler (2 Puffs of 100µg) in a 4-week, Double-Blind, Double-Dummy, Safety and Efficacy Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study to investigate the efficacy and safety of Ba679BR powder inhalation during the continuous once/day administration to the patients with COPD using oxitropium bromide (Tersigan® aerosol) as the comparator drug.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium low, Tiotropium high, Placebo MDI, Placebo inhalation capsule, Oxitropium
- 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.
Tiotropium lowDrug
Tiotropium 18 µg inhalation capsule
Tiotropium highDrug
Tiotropium 36 µg inhalation capsule
Placebo MDIDrug
Placebo metered dose inhaler (MDI)
Placebo inhalation capsuleDrug
OxitropiumDrug
Also called Tersigan®
Oxitropium MDI (100 µg/puff)
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium low & Placebo | Experimental | Tiotropium 18 µg inhalation capsule and Placebo MDI Receives: Drug: Tiotropium low; Drug: Placebo MDI |
| Tiotropium high & Placebo | Experimental | Tiotropium 36 µg inhalation capsule and Placebo MDI Receives: Drug: Tiotropium high; Drug: Placebo MDI |
| Oxitropium & Placebo | Active comparator | Oxitropium MDI (100 µg/puff) and Placebo inhalation capsules Receives: Drug: Placebo inhalation capsule; Drug: Oxitropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough forced expiratory volume in one second (FEV1.0) response
Measured: Day 1, week 2 and 4
Secondary outcomes (13)
FEV1.0 response at 1 hour after administration
Measured: Day 1, week 2 and 4
Trough forced vital capacity (FVC) response
Measured: Day 1, week 2 and 4
FVC response at 1 hour after administration
Measured: Day 1, week 2 and 4
Peak expiratory flow rate (PEF)
Measured: in the morning and at evening every day until week 4
COPD symptom scores
Measured: until week 4
Frequency of rescue use of β2 stimulant
Measured: until week 4
Patient's impression
Measured: week 4
Physician's global evaluation
Measured: week 4
Occurrence of Adverse Events
Measured: up to 4 weeks
Change from baseline in blood pressure
Measured: Baseline, week 4
Change from baseline in heart rate
Measured: Baseline, week 4
Changes in ECG findings
Measured: Baseline, week 4
Changes from baseline in laboratory values
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 posted24 Jun 2014 (estimated)
- Study startDec 2000
- Primary completionSep 2001
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
- 201 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
- NCT02172807
- Sponsor's protocol ID
- 205.226
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Comparison of 18 µg, 36 µg of Ba679BR (Tiotropium) Inhalation Capsules and Oxitropium Metered Dose Inhaler (2 Puffs of 100µg) in a 4-week, Double-Blind, Double-Dummy, Safety and Efficacy Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02172807
- Acronym / sponsor ID
- 205.226
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2000
- Primary completion
- Sep 2001 (actual)
- First posted
- 24 Jun 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.
Study to investigate the efficacy and safety of Ba679BR powder inhalation during the continuous once/day administration to the patients with COPD using oxitropium bromide (Tersigan® aerosol) as the comparator drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tiotropium low & Placebo | Experimental | Drug: Tiotropium low, Drug: Placebo MDITiotropium 18 µg inhalation capsule and Placebo MDI |
| Tiotropium high & Placebo | Experimental | Drug: Tiotropium high, Drug: Placebo MDITiotropium 36 µg inhalation capsule and Placebo MDI |
| Oxitropium & Placebo | Active comparator | Drug: Placebo inhalation capsule, Drug: OxitropiumOxitropium MDI (100 µg/puff) and Placebo inhalation capsules |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Screening FEV1.0 ≤70% of predicted normal vale and screening FEV1.0/FVC ≤70% (the baseline FEV1.0 should also be ≤70% of predicted normal value on the initial day of administration)
- Smoking history ≥ 10 pack-years (a peak-year is 20 cigarettes per day for one year or equivalent)
- Male or female patients 40 years of age or older
Key exclusion criteria (23 listed)
- History of bronchial asthma
- History of an atopic disease such as allergic rhinitis
- Total blood eosinophil count ≥ 600/µL
- Patient treated with antiallergic drugs or anti-histamine drugs
- Patients using oral corticosteroid medication at unstable doses (i.e. less than one month on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisolone per day
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 lowTiotropium 18 µg inhalation capsule | Drug | Tiotropium low & Placebo |
| Tiotropium highTiotropium 36 µg inhalation capsule | Drug | Tiotropium high & Placebo |
| Placebo MDIPlacebo metered dose inhaler (MDI) | Drug | Tiotropium high & Placebo, Tiotropium low & Placebo |
| Placebo inhalation capsule | Drug | Oxitropium & Placebo |
| OxitropiumAlso: Tersigan®Oxitropium MDI (100 µg/puff) | Drug | Oxitropium & Placebo |
Primary outcome
Trough forced expiratory volume in one second (FEV1.0) response
Time frame: Day 1, week 2 and 4
13 secondary outcomes
FEV1.0 response at 1 hour after administration
Time frame: Day 1, week 2 and 4
Trough forced vital capacity (FVC) response
Time frame: Day 1, week 2 and 4
FVC response at 1 hour after administration
Time frame: Day 1, week 2 and 4
Peak expiratory flow rate (PEF)
Time frame: in the morning and at evening every day until week 4
COPD symptom scores
Time frame: until week 4
Frequency of rescue use of β2 stimulant
Time frame: until week 4
Patient's impression
Time frame: week 4
Physician's global evaluation
Time frame: week 4
Occurrence of Adverse Events
Time frame: up to 4 weeks
Change from baseline in blood pressure
Time frame: Baseline, week 4
Change from baseline in heart rate
Time frame: Baseline, week 4
Changes in ECG findings
Time frame: Baseline, week 4
Changes from baseline in laboratory values
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 24 Jun 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 Tiotropium low, Tiotropium high and Oxitropium 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 23 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 24 Jun 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?
Trough forced expiratory volume in one second (FEV1.0) response (time frame: Day 1, week 2 and 4). 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 24 Jun 2014.