Pulmonary Disease, Chronic ObstructivePhase 1NCT02642614
Safety, Tolerability and Pharmacokinetics and Effect on Inflammation of Oral BI 1026706 in Patients With COPD
A Phase 1 study testing BI 1026706 in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 10 sites in 4 countries.
Trial summary
The main objective of the current trial is to investigate safety, tolerability, pharmacokinetics and effect on inflammation of oral BI 1026706 administered twice daily for 4 weeks in patients with COPD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- BI 1026706
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 25 Jan 2016to 14 Jun 2016
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent consistent with ICH-Good Clinical Practice (GCP) guidelines and local legislation prior to participation in the trial. Medication washout and medication restrictions are allowed only after signed informed consent is obtained.
- Males or females not of childbearing potential between 40 and 80 years (each inclusive) of age, on the day of patient´s signature of informed consent.
- All patients must have a documented diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD).
- Post-bronchodilator forced expiratory volume (FEV)1 of >=40% and <=90% of predicted normal at Visit 1
- Post-bronchodilator FEV1/forced vital capacity (FVC) <70% at Visit 1
- Patients must be current or ex-smokers with a smoking history of more than 10 pack years
- Patients on stable respiratory medications for at least 6 weeks prior to randomization (Visit 3).
- Patients must be able to perform technically acceptable pulmonary function tests.
Who cannot join
- Significant pulmonary disease other than COPD or other medical conditions as determined by medical history, examination, and clinical investigations at screening that may, in the opinion of the investigator, result in the any of the following:
- Put the patient at risk because of participation in the study
- Influence the results of the study
- Cast doubt on the patients ability to participate in the study
- Patients with current asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma.
- Patients with clinically relevant abnormal hematology, blood chemistry, or urinalysis at the screening visit (Visit 1), if the abnormality indicates a relevant disease as defined in exclusion criterion number 1. Safety laboratory screening evaluation (Visit 1) can be repeated a maximum of two times.
Show all 26Show fewer
- Patients with a history of myocardial infarction or apoplexy within 6 months of the screening visit (Visit 1) or between the screening visit (Visit 1) and randomization.
- Patients with a history of and/or active life-threatening cardiac arrhythmia, as assessed by the investigator.
- Patients with a marked baseline prolongation of QT/QTcB interval (such as repeated demonstration of a QTcB interval >450 ms), pulse/heart rate outside 50 to 90 bpm at Visit 1 (if confirmed by pulse rate measurement over 60 seconds), or any other relevant ECG finding.
- Patients with a history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome).
- Patients with known active tuberculosis.
- Patients with clinically relevant bronchiectasis, as assessed by the investigator.
- Patients with any respiratory infection (such as common cold, acute sinusitis, or similar illnesses) or COPD exacerbation within 6 weeks prior to the screening visit (Visit 1) or between the screening visit and randomization.
- Patients who have undergone thoracotomy with pulmonary resection (patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1).
- Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last 5 years. Patients with treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed to participate.
- Patients with a history of and/or active significant alcohol or drug abuse as assessed by the investigator.
- Patients who are being treated with non-permitted concomitant medication.
- Patients who have taken an investigational drug within 4 weeks prior to Visit 1 or if screening occurs within six half-lives of intake of another investigational drug (whichever is greater).
- Patients with surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication as assessed by the investigator.
- Patients with veins unsuited for venipuncture (for instance, veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture) as assessed by the investigator.
- Patients who are unable to comply with the dietary regimen.
- Patients who have been previously randomized in this study.
- Patients who have donated more than 100 mL blood in the 4 weeks prior to Visit 1 and between Visit 1 and Visit 3 or patients who have the intention to donate blood between Visit 3 and four weeks after the end of trial visit.
- Patients who are pregnant or breastfeeding
- Male patients who do not agree to minimize the risk of female partners becoming pregnant from the first dosing day until 3 months after the trial medication treatment has finished.
- Patient is assessed as unsuitable for inclusion by the investigator; for instance, because he or she is not considered to comply with study requirements
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Germany6 sites
PAREXEL International GmbH
Berlin, 14050
IKF Pneumologie GmbH & Co. KG
Frankfurt, 60596
Inamed GmbH
Gauting, 82131
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927
Fraunhofer ITEM
Hanover, 30625
KLB Gesundheitsforschung Lübeck GmbH
Lübeck, 23552
Denmark2 sites
Bispebjerg og Frederiksberg Hospital
København NV, 2400
Odense University Hospital
Odense C, 5000
About this study
Official title: A Phase I Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of BI 1026706 Administered Orally as Tablets Twice Daily for 4 Weeks to Patients With COPD in Order to Evaluate Safety, Tolerability, Pharmacokinetics and Effect on Inflammation
The main objective of the current trial is to investigate safety, tolerability, pharmacokinetics and effect on inflammation of oral BI 1026706 administered twice daily for 4 weeks in patients with COPD.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- BI 1026706, 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.
BI 1026706Drug
PlaceboDrug
PlaceboDrug
For blinding purposes
| Study group | Role | What they receive |
|---|---|---|
| BI 1026706 low dose | Experimental | Not described Receives: Drug: BI 1026706; Drug: Placebo |
| BI 1026706 medium | Experimental | Not described Receives: Drug: BI 1026706; Drug: Placebo |
| BI 1026706 high dose | Experimental | Not described Receives: Drug: BI 1026706; Drug: Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of BI 1026706, as Assessed by Frequency (in Percent) of Patients With Treatment Emergent Adverse Events (TEAEs) Over the Treatment Period.
Safety and tolerability of BI 1026706, as assessed by frequency (in percent) of patients with treatment-emergent adverse events (TEAEs) over the treatment period.
Measured: From first drug administration until 4 days after last drug administration, up to 32 days
Secondary outcomes (7)
Change in Absolute Number of Neutrophil in Sputum at the End of the Planned Treatment Period
Change in Absolute Number of Neutrophil in Sputum at the end of the planned treatment period
Measured: 28 days
Maximum Measured Concentration of BI 1026706 in Plasma (Cmax) After the First Dose (Morning of Day 1)
Maximum measured concentration of BI 1026706 in plasma (Cmax) after the first dose (morning of Day 1)
Measured: -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.
Time From Dosing to Maximum Concentration of BI 1026706 in Plasma (Tmax) After the First Dose (Morning of Day 1)
Time from dosing to maximum concentration of BI 1026706 in plasma (Tmax) after the first dose (morning of Day 1)
Measured: -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.
Area Under the Concentration-time Curve of BI 1026706 in Plasma (AUC 0-12h) After the First Dose (Morning of Day 1)
Area under the concentration-time curve of BI 1026706 in plasma (AUC 0-12h) after the first dose (morning of Day 1)
Measured: -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.
Maximum Measured Concentration of BI 1026706 in Plasma at Steady State Over a Uniform Dosing Interval Tau (Cmax, ss) After the Last Dose (Morning of Day 28)
Maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval tau (Cmax, ss) after the last dose (morning of Day 28)
Measured: -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.
Time From Dosing to Maximum Concentration of BI 1026706 in Plasma (Tmax, ss) After the Last Dose (Morning of Day 28)
Time from dosing to maximum concentration of BI 1026706 in plasma (Tmax, ss) after the last dose (morning of Day 28)
Measured: -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.
Area Under the Concentration-time Curve of BI 1026706 in Plasma at Steady State Over a Uniform Dosing Interval Tau (AUC Tau, ss) After the Last Dose (Morning of Day 28)
Area under the concentration-time curve of BI 1026706 in plasma at steady state over a uniform dosing interval tau (AUC tau, ss) after the last dose (morning of Day 28)
Measured: -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study start25 Jan 2016
- Primary completion14 Jun 2016
- Study completion14 Jun 2016
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 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
- NCT02642614
- Sponsor's protocol ID
- 1320.16
- Other IDs
- 2015-002123-25, 2015
- Status last verified
- Aug 2019
- First submitted
- 23 Dec 2015
- Last updated
- 5 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of BI 1026706 Administered Orally as Tablets Twice Daily for 4 Weeks to Patients With COPD in Order to Evaluate Safety, Tolerability, Pharmacokinetics and Effect on Inflammation
- ClinicalTrials.gov ID
- NCT02642614
- Acronym / sponsor ID
- 1320.16
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2016 (actual)
- Primary completion
- 14 Jun 2016 (actual)
- Study completion
- 14 Jun 2016 (actual)
- First posted
- 30 Dec 2015 (estimated)
- Results
- Posted 5 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the current trial is to investigate safety, tolerability, pharmacokinetics and effect on inflammation of oral BI 1026706 administered twice daily for 4 weeks in patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BI 1026706 low dose | Experimental | Drug: BI 1026706, Drug: Placebo |
| BI 1026706 medium | Experimental | Drug: BI 1026706, Drug: Placebo |
| BI 1026706 high dose | Experimental | Drug: BI 1026706, Drug: Placebo |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent consistent with ICH-Good Clinical Practice (GCP) guidelines and local legislation prior to participation in the trial. Medication washout and medication restrictions are allowed only after signed informed consent is obtained.
- Males or females not of childbearing potential between 40 and 80 years (each inclusive) of age, on the day of patient´s signature of informed consent.
- All patients must have a documented diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD).
- Post-bronchodilator forced expiratory volume (FEV)1 of >=40% and <=90% of predicted normal at Visit 1
- Post-bronchodilator FEV1/forced vital capacity (FVC) <70% at Visit 1
Key exclusion criteria (26 listed)
- Significant pulmonary disease other than COPD or other medical conditions as determined by medical history, examination, and clinical investigations at screening that may, in the opinion of the investigator, result in the any of the following:
- Patients with current asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma.
- Patients with clinically relevant abnormal hematology, blood chemistry, or urinalysis at the screening visit (Visit 1), if the abnormality indicates a relevant disease as defined in exclusion criterion number 1. Safety laboratory screening evaluation (Visit 1) can be repeated a maximum of two times.
- Patients with a history of myocardial infarction or apoplexy within 6 months of the screening visit (Visit 1) or between the screening visit (Visit 1) and randomization.
- Patients with a history of and/or active life-threatening cardiac arrhythmia, as assessed by the investigator.
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 |
|---|---|---|
| BI 1026706 | Drug | BI 1026706 high dose, BI 1026706 low dose, BI 1026706 medium |
| Placebo | Drug | Placebo |
| PlaceboFor blinding purposes | Drug | BI 1026706 high dose, BI 1026706 low dose, BI 1026706 medium, Placebo |
Primary outcome
Safety and Tolerability of BI 1026706, as Assessed by Frequency (in Percent) of Patients With Treatment Emergent Adverse Events (TEAEs) Over the Treatment Period.
Time frame: From first drug administration until 4 days after last drug administration, up to 32 days
Safety and tolerability of BI 1026706, as assessed by frequency (in percent) of patients with treatment-emergent adverse events (TEAEs) over the treatment period.
7 secondary outcomes
Change in Absolute Number of Neutrophil in Sputum at the End of the Planned Treatment Period
Time frame: 28 days
Maximum Measured Concentration of BI 1026706 in Plasma (Cmax) After the First Dose (Morning of Day 1)
Time frame: -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.
Time From Dosing to Maximum Concentration of BI 1026706 in Plasma (Tmax) After the First Dose (Morning of Day 1)
Time frame: -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.
Area Under the Concentration-time Curve of BI 1026706 in Plasma (AUC 0-12h) After the First Dose (Morning of Day 1)
Time frame: -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.
Maximum Measured Concentration of BI 1026706 in Plasma at Steady State Over a Uniform Dosing Interval Tau (Cmax, ss) After the Last Dose (Morning of Day 28)
Time frame: -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.
Time From Dosing to Maximum Concentration of BI 1026706 in Plasma (Tmax, ss) After the Last Dose (Morning of Day 28)
Time frame: -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.
Area Under the Concentration-time Curve of BI 1026706 in Plasma at Steady State Over a Uniform Dosing Interval Tau (AUC Tau, ss) After the Last Dose (Morning of Day 28)
Time frame: -0:10 hour(h) before drug administration and 0:30h, 1:00h, 1:30h, 2:00h, 3:00h, 4:00h, 6:00h, 8:00h, and 12:00h after drug administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- 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
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 1026706 in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 10 sites in 4 countries.
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 26 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 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Denmark, Sweden, United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 5 Aug 2019). 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?
Safety and Tolerability of BI 1026706, as Assessed by Frequency (in Percent) of Patients With Treatment Emergent Adverse Events (TEAEs) Over the Treatment Period. (time frame: From first drug administration until 4 days after last drug administration, up to 32 days). 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 5 Aug 2019.