Pulmonary Disease, Chronic ObstructivePhase 3NCT02172430
Comparison of Tiotropium Inhalation Capsules and Oxitropium Metered Dose Inhalator (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Tiotropium powder inhalation capsules and Tersigan® 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 Ba 79 BR (tiotropium) powder inhalation in patients with COPD using oxitropium bromide (Tersigan) as a comparator. Secondarily, the long-term efficacy of Ba 679 BR 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?
- Tiotropium powder inhalation capsules and Tersigan®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- No sites listed yet
- Study dates
- Sep 2000to May 2002
- 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) whose symptoms are stable and who satisfy the following criteria
- Patients with FEV1.0 of <=70% of predicted normal and FEV1.0/FVC of <=70% in the screening test (The FEV1.0 value should also be <=70% of predicted normal on the starting day of administration (visit 2).)
- Patients with a smoking history (<number of cigarettes smoked a day x number of smoking years> is >=200.)
- Male or female patients aged >=40 years old
Who cannot join
- Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
- Patients using oral corticosteroid medication at a dose in excess of the equivalent 10 mg/day of prednisolon
- Patients with glaucoma
- Patients with symptomatic prostatic hypertrophy
- Patients with hypersensitivity to anticholinergic drugs or powder inhalants
- Patients with serious complication who are judged by the investigator to be inappropriate as the subjects of study
Show all 18Show fewer
- Patients demonstrating clinically problematic abnormal laboratory test values (general blood test, biochemical test, urinalysis). Those showing Glutamic Oxaloacetic Transaminase (GOT) and Glutamic PyruvicTransaminase (GPT) twice the upper limit of the normal range, bilirubin 1.25 times or creatinine 1.25 times of the upper limit of normal range are excluded.
- Patients with a recent history of myocardial infarction or heart failure (i.e. within 3 months before the screening test)
- Patients with arrhythmia requiring the treatment with drugs
- Patients for whom the concomitant use of beta-blocker cannot be prohibited.
- Patients who began treatment with an ACE inhibitor within 1 month before the screening test
- Patients with tuberculosis (currently active) or with definite sequela of tuberculosis
- Patients with a recent history of carcinoma (excluding basal cell carcinoma) (i.e. within the past 5 years)
- Patients with a history of cystic fibrosis and bronchiectasis
- Patients with recent onset of upper airway infection (i.e. within 1 month before the screening test)
- Patients who have taken an investigational drug within one month or within period six times of half-lives of that drug (whichever is longer) before the screening test.
- Women who are pregnant or who may become pregnant, or those breast feeding
- Other than above, those who are judged by the investigator to be inappropriate as the subjects of study
About this study
Official title: A Multiple Dose Comparison of Tiotropium 18 μg Inhalation Capsules and Oxitropium MDI (2 Puffs of 100 μg) in a One-year, Open-Label, Safety and Efficacy Study in Patients With COPD
The objective of this study is to investigate the long-term safety of Ba 79 BR (tiotropium) powder inhalation in patients with COPD using oxitropium bromide (Tersigan) as a comparator. Secondarily, the long-term efficacy of Ba 679 BR is also investigated
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium powder inhalation capsules, Tersigan®
- 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 powder inhalation capsulesDrug
Powder inhalation via the HandiHaler® once daily
Tersigan®Drug
2 puffs of oxitropium three times daily via MDI
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium | Experimental | Not described Receives: Drug: Tiotropium powder inhalation capsules |
| Oxitropium bromide | Active comparator | Not described Receives: Drug: Tersigan® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Adverse Events
Measured: up to 52 weeks
Changes from baseline in Blood Pressure / Heart Rate
Measured: up to 52 weeks
Changes from baseline in ECG
Measured: up to 52 weeks
Changes from baseline in laboratory tests
Measured: up to 52 weeks
Secondary outcomes (9)
Changes from baseline in Trough Forced expiratory volume in one second (FEV1.0) response
Measured: week 24 and 52
Changes from baseline in FEV1.0 at 1 hr post-dosing
Measured: week 24 and 52
Changes from baseline in Trough Forced vital capacity (FVC) response
Measured: week 24 and 52
Changes from baseline in FVC at 1 hr post-dosing
Measured: week 24 and 52
Changes from baseline COPD clinical symptoms (Cough frequency, sputum amount, severity of short breath, nocturnal sleep)
Measured: up to 52 weeks
Frequency of rescue use of β2 stimulants
Measured: up to 2 weeks
Changes from baseline in Quality of Life QOL (St George's Respiratory Questionnaire (SGRQ) and Airways Questionnaire-20 (AQ20), if possible)
Measured: week 24 and 52
Patient's impression
Measured: week 24 and 52
Physician's global evaluation
Measured: week 24 and 52
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 startSep 2000
- Primary completionMay 2002
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
- None (open label)
- Enrolment
- 161 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
- NCT02172430
- Sponsor's protocol ID
- 205.227
- Status last verified
- Aug 2018
- First submitted
- 20 Jun 2014
- Last updated
- 31 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Dose Comparison of Tiotropium 18 μg Inhalation Capsules and Oxitropium MDI (2 Puffs of 100 μg) in a One-year, Open-Label, Safety and Efficacy Study in Patients With COPD
- ClinicalTrials.gov ID
- NCT02172430
- Acronym / sponsor ID
- 205.227
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2000
- Primary completion
- May 2002 (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.
The objective of this study is to investigate the long-term safety of Ba 79 BR (tiotropium) powder inhalation in patients with COPD using oxitropium bromide (Tersigan) as a comparator. Secondarily, the long-term efficacy of Ba 679 BR is also investigated
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tiotropium | Experimental | Drug: Tiotropium powder inhalation capsules |
| Oxitropium bromide | Active comparator | Drug: Tersigan® |
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) whose symptoms are stable and who satisfy the following criteria
- Patients with FEV1.0 of <=70% of predicted normal and FEV1.0/FVC of <=70% in the screening test (The FEV1.0 value should also be <=70% of predicted normal on the starting day of administration (visit 2).)
- Patients with a smoking history (<number of cigarettes smoked a day x number of smoking years> is >=200.)
- Male or female patients aged >=40 years old
Key exclusion criteria (18 listed)
- Patients complicated with bronchial asthma, making the assessment of drug efficacy against COPD difficult
- Patients using oral corticosteroid medication at a dose in excess of the equivalent 10 mg/day of prednisolon
- Patients with glaucoma
- Patients with symptomatic prostatic hypertrophy
- Patients with hypersensitivity to anticholinergic drugs or powder inhalants
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 powder inhalation capsulesPowder inhalation via the HandiHaler® once daily | Drug | Tiotropium |
| Tersigan®2 puffs of oxitropium three times daily via MDI | Drug | Oxitropium bromide |
Primary outcome
Occurrence of Adverse Events
Time frame: up to 52 weeks
Changes from baseline in Blood Pressure / Heart Rate
Time frame: up to 52 weeks
Changes from baseline in ECG
Time frame: up to 52 weeks
Changes from baseline in laboratory tests
Time frame: up to 52 weeks
9 secondary outcomes
Changes from baseline in Trough Forced expiratory volume in one second (FEV1.0) response
Time frame: week 24 and 52
Changes from baseline in FEV1.0 at 1 hr post-dosing
Time frame: week 24 and 52
Changes from baseline in Trough Forced vital capacity (FVC) response
Time frame: week 24 and 52
Changes from baseline in FVC at 1 hr post-dosing
Time frame: week 24 and 52
Changes from baseline COPD clinical symptoms (Cough frequency, sputum amount, severity of short breath, nocturnal sleep)
Time frame: up to 52 weeks
Frequency of rescue use of β2 stimulants
Time frame: up to 2 weeks
Changes from baseline in Quality of Life QOL (St George's Respiratory Questionnaire (SGRQ) and Airways Questionnaire-20 (AQ20), if possible)
Time frame: week 24 and 52
Patient's impression
Time frame: week 24 and 52
Physician's global evaluation
Time frame: week 24 and 52
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 31 Aug 2018.
- 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 Tiotropium powder inhalation capsules and Tersigan® 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 18 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 31 Aug 2018. 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?
Occurrence of Adverse Events (time frame: up to 52 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 31 Aug 2018.