NCT01958008

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

January 20, 2017

Completed
Last Updated

January 20, 2017

Status Verified

November 1, 2016

Enrollment Period

8 months

First QC Date

October 1, 2013

Results QC Date

November 23, 2016

Last Update Submit

November 23, 2016

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • Number (%) of Patients With Drug-related Adverse Events (AEs)

    Number (%) of patients with drug-related adverse events (AEs)

    AE's occuring upto end of treatment + 3 days follow up (Up to 31 days)

Secondary Outcomes (6)

  • Cmax,ss

    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

    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

    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

    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)

    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

  • +1 more secondary outcomes

Study Arms (3)

BI 113608 low dose b.i.d.

EXPERIMENTAL

Film-coated tablet, oral administration with 240 mL water

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

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

Drug: Placebo to BI 113608 high dose b.i.d.Drug: BI 113608 high dose b.i.d.

Interventions

Placebo to BI 113608 high dose b.i.d.DRUG

Film-coated tablet

BI 113608 high dose b.i.d.
Placebo to BI 113608 low dose b.i.d.DRUG

Film-coated tablet

BI 113608 low dose b.i.d.
BI 113608 high dose b.i.d.DRUG

Film-coated tablet

BI 113608 high dose b.i.d.
Placebo to BI 113608 medium dose b.i.d.DRUG

Film-coated tablet

BI 113608 medium dose b.i.d.
BI 113608 low dose b.i.d.DRUG

Film-coated tablet

BI 113608 low dose b.i.d.
BI 113608 medium dose b.i.d.DRUG

Film-coated tablet

BI 113608 medium dose b.i.d.

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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.

You may not qualify if:

  • 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).
  • 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 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site

Frankfurt, Germany

Location

Boehringer Ingelheim Investigational Site

Gauting, Germany

Location

Boehringer Ingelheim Investigational Site

Großhansdorf, Germany

Location

Boehringer Ingelheim Investigational Site

Lübeck, Germany

Location

Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim
clintriage.rdg@boehringer-ingelheim.com
800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2013

First Posted

October 8, 2013

Study Start

September 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

January 20, 2017

Results First Posted

January 20, 2017

Record last verified: 2016-11

Locations

DE(6)