Pulmonary Disease, Chronic ObstructivePhase 2NCT02030535
Study to Evaluate the Effect on Lung Function and ECG When a Combination of Tiotropium Plus Olodaterol is Administered to Patients With COPD Either From a Single Inhaler or Each Compound is Administered After Each Other From Two Different Inhalers
A Phase 2 study testing olodaterol and tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 6 sites in Germany.
Trial summary
The primary objective of this study is to evaluate the efficacy and safety of orally inhaled tiotropium and olodaterol as both a fixed dose combination and a free combination with respect to lung function and ECG parameters 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?
- olodaterol and tiotropium
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 6 sitesGermany
- Study dates
- Jan 2014to Jun 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- patients must sign informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
- Patients must have a diagnosis of COPD and must meet the following spirometric criteria:
- Patients must have relatively stable airway obstruction with a post-bronchodilator (10 to 45 minutes after 400mcg salbutamol) FEV1>30% and < 80% of predicted normal (ECSC, GOLD II - III) and a post-bronchodilator FEV1/FVC <70% at Visit 1
- Male or female patients, 40 years of age or older.
- Patients must be current or ex-smokers with a smoking history of more than 10 pack years.
- Patients who have never smoked cigarettes must be excluded.
- Patients must be able to perform technically acceptable pulmonary function tests according to ATS/ERS guidelines and maintain records in a paper diary
- Patients must be able to inhale medication in a competent manner from the RESPIMAT inhaler and from a metered dose inhaler (MDI).
Who cannot join
- Significant disease other than COPD
- Clinically relevant abnormal lab values.
- History of asthma.
- Diagnosis of thyrotoxicosis
- Diagnosis of paroxysmal tachycardia
- History of myocardial infarction within 1 year of screening visit
Show all 25Show fewer
- Unstable or life-threatening cardiac arrhythmia
- Hospitalization for heart failure within the past year
- Known active tuberculosis
- Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
- History of life-threatening pulmonary obstruction and patients with chronic respiratory failure
- History of cystic fibrosis
- Clinically evident bronchiectasis
- History of significant alcohol or drug abuse
- Thoracotomy with pulmonary resection
- Patients treated with oral or patch ß-adrenergics
- Patients treated with oral corticosteroid medication at unstable doses or at doses in excess of 10mg prednisolone per day or equivalent
- Regular use of daytime oxygen therapy for more than one hour per day
- Pulmonary rehabilitation program in the six weeks prior to the screening visit or patients currently in a pulmonary rehabilitation program
- Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
- Known hypersensitivity to ß-adrenergic and/or anticholinergic drugs, BAC, EDTA
- Pregnant or nursing women
- Women of childbearing potential not using a highly effective method of birth control
- Patient who have previously been randomized in this study or are currently participating in another study
- Patients who are unable to comply with pulmonary medication restrictions prior to randomization
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
1237.7.49004 Boehringer Ingelheim Investigational Site
Berlin
1237.7.49005 Boehringer Ingelheim Investigational Site
Berlin
1237.7.49007 Boehringer Ingelheim Investigational Site
Frankfurt
1237.7.49002 Boehringer Ingelheim Investigational Site
Großhansdorf
1237.7.49003 Boehringer Ingelheim Investigational Site
Hamburg
1237.7.49001 Boehringer Ingelheim Investigational Site
Weinheim
About this study
Official title: A Randomised, Placebo-controlled, Double-blind, Single Dose, Cross-over Study to Evaluate the Efficacy and Safety of Orally Inhaled Tiotropium + Olodaterol as Both a Fixed Dose Combination and a Free Combination (Both Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The primary objective of this study is to evaluate the efficacy and safety of orally inhaled tiotropium and olodaterol as both a fixed dose combination and a free combination with respect to lung function and ECG parameters
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- olodaterol, tiotropium, Placebo
- 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.
olodaterolDrug
free combination with tiotropium
tiotropiumDrug
free combination with olodaterol
PlaceboDrug
tiotropiumDrug
fixed dose combination with olodaterol
olodaterolDrug
fixed dose combination with tiotropium
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium/Olodaterol FDC | Experimental | patient will receive tiotropium and olodaterol in a fixed dose combination Receives: Drug: tiotropium; Drug: olodaterol |
| Tiotropium and Olodaterol FC | Experimental | patient will receive tiotropium and olodaterol in a free combination Receives: Drug: olodaterol; Drug: tiotropium |
| Placebo | Placebo comparator | patient will receive placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3hours) Response After Single-dose Administration
The response was defined as the change from patient baseline. Patient baseline was the average of the mean pre-dose values (period baseline) on each test day (Visit 2 (Day 1), Visit 3 (Day 22 (±7days)), and Visit 4 (Day 43±7days)).
For patients who did not complete all periods, patient baseline was the average of the available period baselines.
The means presented are the adjusted means.
Measured: 1 hour (h) and 10 min pre-dose and at 15 min, 30 min, 1 h, 2 h and 3 h post-dose
Secondary outcomes (20)
Mean (Heart Rate Corrected QT Interval (Using Fredericia Adjustment)) QTcF Interval Change From Patient Baseline Over All Post-dose Time Points
Mean QTcF interval change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Measured: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Peak QTcF Interval Change From Patient Baseline Over All Post-dose Time Points
Peak QTcF interval change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Measured: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Mean Heart Rate Change From Patient Baseline Over All Post-dose Time Points
Mean heart rate change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Measured: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Peak Heart Rate Change From Patient Baseline Over All Post-dose Time Points
Peak heart rate change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Measured: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Heart Rate Change From Patient Baseline at Individual Post-dose Time Points
Heart rate change from patient baseline at individual post-dose time points
Measured: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Mean RR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points
Mean RR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Measured: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Peak RR Change From Patient Baseline Over All Post-dose Time Points
Peak RR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Measured: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
RR Change From Patient Baseline at Individual Post-dose Time Points
RR change from patient baseline at individual post-dose time points
Measured: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Mean QT (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points
Mean QT change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Measured: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Peak QT (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points
Peak QT change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Measured: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
QT Change From Patient Baseline at Individual Post-dose Time Points
QT change from patient baseline at individual post-dose time points
Measured: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Mean QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points
Mean QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment))change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Measured: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Peak QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points
Peak QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment))change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Measured: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
QTcB Change From Patient Baseline at Individual Post-dose Time Points
QTcB change from patient baseline at individual post-dose time points
Measured: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Mean PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points
Mean PR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Measured: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Peak PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points
Peak PR change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Measured: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
PR Change From Patient Baseline at Individual Post-dose Time Points
PR change from patient baseline at individual post-dose time points
Measured: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Mean QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points
Mean QRS change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Measured: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Peak QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points
Peak QRS change from patient baseline over all post-dose time points (5min, 10min, 25min and 50min)
Measured: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
QRS Change From Patient Baseline at Individual Post-dose Time Points
QRS change from patient baseline at individual post-dose time points
Measured: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02030535
- Sponsor's protocol ID
- 1237.7
- Other IDs
- 2013-002652-32
- Status last verified
- Jun 2015
- First submitted
- 7 Jan 2014
- Last updated
- 16 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Placebo-controlled, Double-blind, Single Dose, Cross-over Study to Evaluate the Efficacy and Safety of Orally Inhaled Tiotropium + Olodaterol as Both a Fixed Dose Combination and a Free Combination (Both Delivered by the Respimat® Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02030535
- Acronym / sponsor ID
- 1237.7
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Posted 16 Jul 2015
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 is to evaluate the efficacy and safety of orally inhaled tiotropium and olodaterol as both a fixed dose combination and a free combination with respect to lung function and ECG parameters
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tiotropium/Olodaterol FDC | Experimental | Drug: tiotropium, Drug: olodaterolpatient will receive tiotropium and olodaterol in a fixed dose combination |
| Tiotropium and Olodaterol FC | Experimental | Drug: olodaterol, Drug: tiotropiumpatient will receive tiotropium and olodaterol in a free combination |
| Placebo | Placebo comparator | Drug: Placebopatient will receive placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- patients must sign informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
- Patients must have a diagnosis of COPD and must meet the following spirometric criteria:
- Patients must have relatively stable airway obstruction with a post-bronchodilator (10 to 45 minutes after 400mcg salbutamol) FEV1>30% and < 80% of predicted normal (ECSC, GOLD II - III) and a post-bronchodilator FEV1/FVC <70% at Visit 1
- Male or female patients, 40 years of age or older.
- Patients must be current or ex-smokers with a smoking history of more than 10 pack years.
Key exclusion criteria (25 listed)
- Significant disease other than COPD
- Clinically relevant abnormal lab values.
- History of asthma.
- Diagnosis of thyrotoxicosis
- Diagnosis of paroxysmal tachycardia
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 |
|---|---|---|
| olodaterolfree combination with tiotropium | Drug | Tiotropium and Olodaterol FC |
| tiotropiumfree combination with olodaterol | Drug | Tiotropium and Olodaterol FC |
| Placebo | Drug | Placebo |
| tiotropiumfixed dose combination with olodaterol | Drug | Tiotropium/Olodaterol FDC |
| olodaterolfixed dose combination with tiotropium | Drug | Tiotropium/Olodaterol FDC |
Primary outcome
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3hours) Response After Single-dose Administration
Time frame: 1 hour (h) and 10 min pre-dose and at 15 min, 30 min, 1 h, 2 h and 3 h post-dose
The response was defined as the change from patient baseline. Patient baseline was the average of the mean pre-dose values (period baseline) on each test day (Visit 2 (Day 1), Visit 3 (Day 22 (±7days)), and Visit 4 (Day 43±7days)). For patients who did not complete all periods, patient baseline was the average of the available period baselines. The means presented are the adjusted means.
20 secondary outcomes
Mean (Heart Rate Corrected QT Interval (Using Fredericia Adjustment)) QTcF Interval Change From Patient Baseline Over All Post-dose Time Points
Time frame: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Peak QTcF Interval Change From Patient Baseline Over All Post-dose Time Points
Time frame: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Mean Heart Rate Change From Patient Baseline Over All Post-dose Time Points
Time frame: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Peak Heart Rate Change From Patient Baseline Over All Post-dose Time Points
Time frame: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Heart Rate Change From Patient Baseline at Individual Post-dose Time Points
Time frame: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Mean RR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points
Time frame: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Peak RR Change From Patient Baseline Over All Post-dose Time Points
Time frame: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
RR Change From Patient Baseline at Individual Post-dose Time Points
Time frame: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Mean QT (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points
Time frame: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Peak QT (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points
Time frame: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
QT Change From Patient Baseline at Individual Post-dose Time Points
Time frame: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Mean QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points
Time frame: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Peak QTcB (Heart Rate Corrected QT Interval (Using Bazett Adjustment)) Change From Patient Baseline Over All Post-dose Time Points
Time frame: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
QTcB Change From Patient Baseline at Individual Post-dose Time Points
Time frame: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Mean PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points
Time frame: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Peak PR (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points
Time frame: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
PR Change From Patient Baseline at Individual Post-dose Time Points
Time frame: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Mean QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points
Time frame: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Peak QRS (Time Interval of ECG) Change From Patient Baseline Over All Post-dose Time Points
Time frame: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
QRS Change From Patient Baseline at Individual Post-dose Time Points
Time frame: 40 min pre-dose and at 5 min, 10 min, 25 min and 50 min post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 chair
Boehringer Ingelheim
6 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 olodaterol and tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 6 sites in Germany.
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 8 inclusion and 25 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 16 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 16 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) (0-3hours) Response After Single-dose Administration (time frame: 1 hour (h) and 10 min pre-dose and at 15 min, 30 min, 1 h, 2 h and 3 h post-dose). 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 16 Jul 2015.