Pulmonary Disease, Chronic ObstructivePhase 1NCT01958008
BI 113608 Administered as Tablets Twice Daily Over 4 Weeks in Patients With Chronic Obstructive Pulmonary Disease Associated With Chronic Bronchitis
A Phase 1 study testing BI 113608 high dose b.i.d. and BI 113608 low dose b.i.d. in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 6 sites in Germany.
Trial summary
The main objective of the current trial is to investigate safety, tolerability and pharmacokinetics of BI 113608 in COPD patients with symptoms of chronic bronchitis. 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 113608 high dose b.i.d. and BI 113608 low dose b.i.d.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 6 sitesGermany
- Study dates
- Sep 2013to May 2014
- 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
- All patients must sign an informed consent consistent with ICH-GCP guidelines and local legislations prior to any study-related procedures, which includes medication washout and restrictions.
- All patients must have a documented diagnosis of COPD according to GOLD 2013.
- Post-bronchodilator 50% = FEV1 < 80% of predicted at screening visit.
- Post-bronchodilator FEV1/FVC <70% at screening visit.
- Patients must have a history of chronic bronchitis as defined by symptoms of cough and sputum production on most days during at least three months for the past two consecutive years.
- CAT Questionnaire at screening: a score of at least one for both cough (1st question) and sputum (2nd question).
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- Males and females between 40 and 80 years (inclusive) of age, on the day of patient´s signature of informed consent.
- 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 (body plethysmography, forced spirometry and DLCO measurement).
- Females must be of non-childbearing potential. Women of non-childbearing potential are defined as those who have undergone bilateral ovariectomy, bilateral salpingectomy or hysterectomy. If so, documentation confirming the surgical procedure must be available on the patient's source documents. A woman is also presumed to be infertile due to natural causes if she has been amenorrheic for more than 24 months. In questionable cases, a blood analysis of FSH and estradiol, which indicates the postmenopausal status according to the central laboratory ranges for postmenopausal females, is considered confirmatory.
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,
- Cause concern regarding the patient's ability to participate in the study. (*e.g. cardiac, gastro-intestinal, hepatic, renal, metabolic, dermatologic, neurological, haematological, oncological and psychiatric; history of relevant orthostatic hypotension, fainting spells or blackouts; current chronic or relevant acute infections.)
- Patients with any lung disease other than COPD (e.g. asthma, interstitial lung disease (ILD), cystic fibrosis, active tuberculosis, post-TB syndrome, clinically evident bronchiectasis, with a history of thoracotomy with pulmonary resection).
- Patients with clinically relevant abnormal haematology, blood chemistry, or urinalysis at screening visit (Visit 1), if the abnormality defines a relevant disease as defined in exclusion criterion number 1.
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- All patients with a serum glutamate oxaloacetate transferase (SGOT) or serum glutamic pyruvic transaminase (SGPT) or total bilirubin higher than 1.5-fold ULN or serum creatinine higher than normal at Visit 1 (and at all repeated tests, if applicable) will be excluded regardless of the clinical condition. Laboratory evaluation can be repeated maximum two times.
- A malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years (patients with treated basal cell carcinoma are allowed).
- Patients with current relevant psychiatric disorders based on the investigator´s judgement.
- Patients with any respiratory infection (e.g. common cold, sinusitis, etc.) or COPD exacerbation within the six weeks prior to the screening visit (Visit 1) or between screening visit and randomization.
- Patients with a history of two or more moderate or severe COPD exacerbations per year within the last two years.
- Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion number 1.
- Patients who are being treated with non-permitted concomitant medication.
- Patients with a recent history (i.e. three years or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy.
- Patients who have previously been randomised in this trial.
- Current participation in another clinical trial (as defined in the ICH Harmonised Tripartite Guideline for Good Clinical Practice (GCP)).
- Donation of more than 100 mL of blood within the past four weeks prior to screening.
- A history of additional risk factors for torsade-de-pointes (e.g., heart failure, relevant hypokalemia, family history of Long QT Syndrome).
- Pregnant or nursing women.
- Gastrointestinal tract surgery that might affect absorption and elimination of drugs.
- Patients with known hypersensitivity / allergy to the investigational medicinal product (IMP) or its excipients.
- Male Patients who do not agree to minimize the risk of female partners becoming pregnant from the first dosing day until two months after study completion.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Boehringer Ingelheim Investigational Site
Berlin
Boehringer Ingelheim Investigational Site
Frankfurt
Boehringer Ingelheim Investigational Site
Gauting
Boehringer Ingelheim Investigational Site
Großhansdorf
Boehringer Ingelheim Investigational Site
Lübeck
Boehringer Ingelheim Investigational Site
Mannheim
About this study
Official title: Randomized, Placebo-controlled, Double-blind Within Dose Groups, Multiple Rising-dose Study to Evaluate Safety, Tolerability, and PK of Oral BI 113608 Administered as Tablets Twice Daily Over 4 Weeks in Patients With COPD Associated With Chronic Bronchitis
The main objective of the current trial is to investigate safety, tolerability and pharmacokinetics of BI 113608 in COPD patients with symptoms of chronic bronchitis.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Placebo to BI 113608 high dose b.i.d., Placebo to BI 113608 low dose b.i.d., BI 113608 high dose b.i.d., Placebo to BI 113608 medium dose b.i.d., BI 113608 low dose b.i.d.
- 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.
Placebo to BI 113608 high dose b.i.d.Drug
Film-coated tablet
Placebo to BI 113608 low dose b.i.d.Drug
Film-coated tablet
BI 113608 high dose b.i.d.Drug
Film-coated tablet
Placebo to BI 113608 medium dose b.i.d.Drug
Film-coated tablet
BI 113608 low dose b.i.d.Drug
Film-coated tablet
BI 113608 medium dose b.i.d.Drug
Film-coated tablet
| Study group | Role | What they receive |
|---|---|---|
| BI 113608 low dose b.i.d. | Experimental | Film-coated tablet, oral administration with 240 mL water Receives: Drug: Placebo to BI 113608 low dose b.i.d.; Drug: BI 113608 low dose b.i.d. |
| BI 113608 medium dose b.i.d. | Experimental | Film-coated tablet, oral administration with 240 mL water Receives: Drug: Placebo to BI 113608 medium dose b.i.d.; Drug: BI 113608 medium dose b.i.d. |
| BI 113608 high dose b.i.d. | Experimental | Film-coated tablet, oral administration with 240 mL water Receives: Drug: Placebo to BI 113608 high dose b.i.d.; Drug: BI 113608 high dose b.i.d. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number (%) of Patients With Drug-related Adverse Events (AEs)
Number (%) of patients with drug-related adverse events (AEs)
Measured: AE's occuring upto end of treatment + 3 days follow up (Up to 31 days)
Secondary outcomes (6)
Cmax,ss
Cmax,ss (maximum measured concentration of BI 113608 in plasma at steady state over a uniform dosing interval tau)
Measured: Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration
AUC Tau,ss
AUC tau,ss (area under the concentration-time curve of the BI 113608 in plasma at steady state over a uniform dosing interval tau)
Measured: Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration
Tmax,ss
Tmax,ss (time from last dosing to maximum concentration of the BI 113608 in plasma at steady state)
Measured: Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration
T1/2,ss
T1/2,ss (terminal half life of the BI 113608 in plasma at steady state)
Measured: Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration
R(A,Cmax)
R(A,Cmax) (accumulation ratio of the BI 113608 in plasma at steady state after multiple oral administration over a uniform dosing interval tau, expressed as ratio of Cmax at steady state and after first dose)
Measured: Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration
R(A,AUC)
R(A,AUC) (accumulation ratio of the BI 113608 in plasma at steady state after multiple oral administration over a uniform dosing interval tau, expressed as ratio of AUC at steady state and after first dose)
Measured: Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours 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 posted8 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionMay 2014
- Study completionMay 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 84 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
- NCT01958008
- Sponsor's protocol ID
- 1314.5
- Other IDs
- 2012-005451-16
- Status last verified
- Nov 2016
- First submitted
- 1 Oct 2013
- Last updated
- 20 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Placebo-controlled, Double-blind Within Dose Groups, Multiple Rising-dose Study to Evaluate Safety, Tolerability, and PK of Oral BI 113608 Administered as Tablets Twice Daily Over 4 Weeks in Patients With COPD Associated With Chronic Bronchitis
- ClinicalTrials.gov ID
- NCT01958008
- Acronym / sponsor ID
- 1314.5
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Posted 20 Jan 2017
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 and pharmacokinetics of BI 113608 in COPD patients with symptoms of chronic bronchitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BI 113608 low dose b.i.d. | Experimental | Drug: Placebo to BI 113608 low dose b.i.d., Drug: BI 113608 low dose b.i.d.Film-coated tablet, oral administration with 240 mL water |
| BI 113608 medium dose b.i.d. | Experimental | Drug: Placebo to BI 113608 medium dose b.i.d., Drug: BI 113608 medium dose b.i.d.Film-coated tablet, oral administration with 240 mL water |
| BI 113608 high dose b.i.d. | Experimental | Drug: Placebo to BI 113608 high dose b.i.d., Drug: BI 113608 high dose b.i.d.Film-coated tablet, oral administration with 240 mL water |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- All patients must sign an informed consent consistent with ICH-GCP guidelines and local legislations prior to any study-related procedures, which includes medication washout and restrictions.
- All patients must have a documented diagnosis of COPD according to GOLD 2013.
- Post-bronchodilator 50% = FEV1 < 80% of predicted at screening visit.
- Post-bronchodilator FEV1/FVC <70% at screening visit.
- Patients must have a history of chronic bronchitis as defined by symptoms of cough and sputum production on most days during at least three months for the past two consecutive years.
Key exclusion criteria (22 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 any lung disease other than COPD (e.g. asthma, interstitial lung disease (ILD), cystic fibrosis, active tuberculosis, post-TB syndrome, clinically evident bronchiectasis, with a history of thoracotomy with pulmonary resection).
- Patients with clinically relevant abnormal haematology, blood chemistry, or urinalysis at screening visit (Visit 1), if the abnormality defines a relevant disease as defined in exclusion criterion number 1.
- All patients with a serum glutamate oxaloacetate transferase (SGOT) or serum glutamic pyruvic transaminase (SGPT) or total bilirubin higher than 1.5-fold ULN or serum creatinine higher than normal at Visit 1 (and at all repeated tests, if applicable) will be excluded regardless of the clinical condition. Laboratory evaluation can be repeated maximum two times.
- A malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years (patients with treated basal cell carcinoma are allowed).
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 |
|---|---|---|
| Placebo to BI 113608 high dose b.i.d.Film-coated tablet | Drug | BI 113608 high dose b.i.d. |
| Placebo to BI 113608 low dose b.i.d.Film-coated tablet | Drug | BI 113608 low dose b.i.d. |
| BI 113608 high dose b.i.d.Film-coated tablet | Drug | BI 113608 high dose b.i.d. |
| Placebo to BI 113608 medium dose b.i.d.Film-coated tablet | Drug | BI 113608 medium dose b.i.d. |
| BI 113608 low dose b.i.d.Film-coated tablet | Drug | BI 113608 low dose b.i.d. |
| BI 113608 medium dose b.i.d.Film-coated tablet | Drug | BI 113608 medium dose b.i.d. |
Primary outcome
Number (%) of Patients With Drug-related Adverse Events (AEs)
Time frame: AE's occuring upto end of treatment + 3 days follow up (Up to 31 days)
Number (%) of patients with drug-related adverse events (AEs)
6 secondary outcomes
Cmax,ss
Time frame: Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration
AUC Tau,ss
Time frame: Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration
Tmax,ss
Time frame: Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration
T1/2,ss
Time frame: Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration
R(A,Cmax)
Time frame: Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration
R(A,AUC)
Time frame: Pre-dose and 0:15(hours:min),0:30,0:45,1:00,1:30,2:00,3:00,4:00,6:00,9:00,11:45,71:45,167:45,611:45,623:45,635:45,647:45,648:15,648:30,648:45,649:00,649:30,650:00,651:00,652:00,654:00,657:00,660:00,672:00,696:00,720:00 hours after drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
- 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 1 study testing BI 113608 high dose b.i.d. and BI 113608 low dose b.i.d. 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 10 inclusion and 22 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 20 Jan 2017. 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. 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 20 Jan 2017). 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?
Number (%) of Patients With Drug-related Adverse Events (AEs) (time frame: AE's occuring upto end of treatment + 3 days follow up (Up to 31 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 20 Jan 2017.