Pulmonary Disease, Chronic ObstructivePhase 2NCT00720499
Efficacy and Safety of 4 Weeks of Treatment With Orally Inhaled BI1744/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study testing BI 1744 CL plus tiotropium bromide and Respimat® Inhaler in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 24 sites in 4 countries.
Trial summary
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL administered with 5 microgram tiotropium bromide solution for inhalation, delivered by the Respimat® inhaler, once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD). 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?
- BI 1744 CL plus tiotropium bromide and Respimat® Inhaler
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 24 sitesin 4 countries
- Study dates
- Jul 2008to Feb 2009
- 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
- All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions
- All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
- Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 >= 30% of predicted normal and <80% of predicted normal 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 must be able to perform technically acceptable pulmonary function tests and PEF measurements, and must be able to maintain records (Patient Daily e-Diary) during the study period as required in the protocol
- Patients must be able to inhale medication in a competent manner from the Respimat inhaler and from a metered dose inhaler (MDI).
- additional inclusion criteria apply.
Who cannot join
- Patients with a significant disease other than COPD
- Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis;
- Patients with a history of asthma or a total blood eosinophil count >= 600/mm3.
- Patients with any of the following conditions:a diagnosis of thyrotoxicosis, a diagnosis of paroxysmal tachycardia (>100 beats per minute), a marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTcF* interval > 450 ms), a history of additional risk factors for Torsade de Pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT Syndrome)
- Patients with any of the following conditions:a history of myocardial infarction within 1 year of screening visit (Visit 1), a diagnosis of clinically relevant cardiac arrhythmia, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, a history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis, a history of significant alcohol or drug abuse
- Patients who have undergone thoracotomy with pulmonary resection
Show all 13Show fewer
- Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits.
- Pregnant or nursing women
- Women of childbearing potential not using two effective method of birth control (one barrier and one non-barrier). Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years
- Patients 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
- Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit
- additional exclusion criteria apply.
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
Germany9 sites
1237.9.04952 Boehringer Ingelheim Investigational Site
Berlin
1237.9.04953 Boehringer Ingelheim Investigational Site
Berlin
1237.9.04954 Boehringer Ingelheim Investigational Site
Berlin
1237.9.04955 Boehringer Ingelheim Investigational Site
Bruchsal
1237.9.04959 Boehringer Ingelheim Investigational Site
Gelnhausen
1237.9.04960 Boehringer Ingelheim Investigational Site
Großhansdorf
1237.9.04958 Boehringer Ingelheim Investigational Site
Hamburg
1237.9.04951 Boehringer Ingelheim Investigational Site
Tübingen
1237.9.04956 Boehringer Ingelheim Investigational Site
Wiesloch
United States5 sites
1237.9.00152 Boehringer Ingelheim Investigational Site
Clearwater, Florida
1237.9.00154 Boehringer Ingelheim Investigational Site
Killeen, Texas
1237.9.00151 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1237.9.00153 Boehringer Ingelheim Investigational Site
Spokane, Washington
1237.9.00155 Boehringer Ingelheim Investigational Site
Tampa, Florida
Belgium5 sites
1237.9.03253 Boehringer Ingelheim Investigational Site
Brussels
1237.9.03255 Boehringer Ingelheim Investigational Site
Brussels
1237.9.03254 Boehringer Ingelheim Investigational Site
Edegem
1237.9.03251 Boehringer Ingelheim Investigational Site
Ghent
1237.9.03252 Boehringer Ingelheim Investigational Site
Leuven
Canada5 sites
1237.9.00255 Boehringer Ingelheim Investigational Site
Mississauga, Ontario
1237.9.00253 Boehringer Ingelheim Investigational Site
Ste-Foy, Quebec
1237.9.00251 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1237.9.00252 Boehringer Ingelheim Investigational Site
Toronto, Ontario
1237.9.00254 Boehringer Ingelheim Investigational Site
Toronto, Ontario
About this study
Official title: Randomised, Double-blind, Cross-over Study to Assess the Efficacy and Safety of 4 Weeks of Once Daily Treatment of 2 Doses of Orally Inhaled BI 1744 CL, Each in Fixed Dose Combination (FDC) With 5 Microgram Tiotropium Bromide (Delivered by the Respimat® Inhaler) in Patients With COPD
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL administered with 5 microgram tiotropium bromide solution for inhalation, delivered by the Respimat® inhaler, once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- BI 1744 CL plus tiotropium bromide, Respimat® Inhaler
- 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 1744 CL plus tiotropium bromideDrug
BI 1744 CL plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
Respimat® InhalerDevice
| Study group | Role | What they receive |
|---|---|---|
| BI 1744 CL low dose+tiotropium bromide | Experimental | BI 1744 CL low dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation Receives: Drug: BI 1744 CL plus tiotropium bromide; Device: Respimat® Inhaler |
| BI 1744 CL medium dose+tiotropium bromide | Experimental | BI 1744 CL medium dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation Receives: Drug: BI 1744 CL plus tiotropium bromide; Device: Respimat® Inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough Forced Expiratory Volume in One Second (FEV1) Response [L] After Four Weeks of Treatment.
Trough FEV1 was defined as the mean of the 2 FEV1 values at the end of the dosing interval, 24 hours post-drug administration.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).
Measured: 1 hour (h), 10 minutes (min) before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29
Secondary outcomes (28)
Trough FEV1 Response [L] After 2 Weeks of Treatment
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).
Measured: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 15
Individual FEV1 Measurements
Individual FEV1 measurements [L] at each time point on Day 29.
The presented means are adjusted.
Measured: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29
FEV1 AUC 0-3h, Response
FEV1 Area Under the Curve (AUC) 0-3h, response [L] on days 1, 15 and 29.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).
Measured: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29
FEV1 Peak 0-3h Response
FEV1 peak value over the time from 0 to 3 hours (peak 0-3h) response [L] on days 1, 15 and 29.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).
Measured: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29
FEV1, AUC (0-6h) Response
FEV1, AUC (0-6h) response [L] on day 29.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).
Measured: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29
FEV1 (Unsupervised) AUC (6-12h) Response
FEV1 (unsupervised) AUC (6-12h) response [L] on day 29.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).
Measured: 6 hours (h), 9h and 12h after drug administration on day 29
Trough FVC Response
Trough Forced Vital Capacity (FVC) response [L] on days 15 and 29.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).
Measured: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 15, in addition 4h, 5h, 6h after drug administration on day 29
Individual FVC Measurements
Individual FVC measurements [L] at each time point
The categories correspond to the planned times for FVC measurements on Day 29.
The presented means are adjusted.
Measured: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29
FVC AUC (0-3h) Response
FVC AUC (0-3h) response [L] on days 1, 15 and 29.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).
Measured: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29
FVC AUC (0-6h) Response
FVC AUC (0-6h) response [L] on day 29.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).
Measured: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29
FVC Peak 0-3h Response
FVC peak 0-3h response [L] on day 29.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).
Measured: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 29
PEFR AUC (0-3h) Response
Peak Expiratory Flow Rate (PEFR) AUC (0-3h) response [L/min] on days 1, 15 and 29.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).
Measured: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29
PEFR Peak 0-3h Response
PEFR peak 0-3h response [L/min] on days 1, 15 and 29.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).
Measured: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29
PEFR AUC (6-12h) Response
PEFR AUC (6-12h) response [L] on day 29.
Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period.
The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).
Measured: 1 hour (h) and 10 minutes before drug administration on day 1 and 6h, 9h and 12h after drug administration on day 29
Weekly Mean Morning PEFR
Weekly mean morning PEFR [L/min] on weeks 1,2,3 and 4.
The presented means are adjusted.
Measured: Weeks 1,2,3 and 4
Weekly Mean Evening PEFR
Weekly mean evening PEFR [L/min] on weeks 1,2,3 and 4.
The presented means are adjusted.
Measured: Weeks 1,2,3 and 4
Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (PRN Salbutamol [Albuterol])
Weekly mean number of occasions of rescue therapy used per day (as occasion require (PRN) salbutamol [albuterol]) on weeks 1,2,3 and 4.
The means presented are the adjusted mean of weekly mean.
Measured: Weeks 1,2,3 and 4
Patient Global Rating
Patient global rating scores treatment comparison after 4 weeks
The score was evaluated on a 7-point scale :
- 1 : very much better
- 2 : much better
- 3 : a little better
- 4 : no change
- 5 : a little worse
- 6 : much worse
- 7 : very much worse
The presented means are adjusted.
Measured: 4 weeks
Physician's Global Evaluation
Physician's global evaluation score on days 15 and 29
The score was evaluated on a 8-points scale :
- Poor : 1,2
- Fair : 3,4
- Good : 5,6
- Excellent : 7,8
The presented means are adjusted
Measured: Days 15 and 29
Clinically Significant Abnormalities for Blood Chemistry, Haematology, Urinalysis and Physical Examination
Clinically significant abnormalities for blood chemistry, haematology, urinalysis and physical examination
Measured: 14 weeks
Overall Marked Changes From Baseline in Vital Signs
Overall marked changes from baseline in systolic blood pressure, diastolic blood pressure and pulse rate.
Measured: Baseline to week 14
12-lead ECG Heart Rate
12-lead Electrocardiogram (ECG) Heart rate baseline and change from baseline values at other time points in Beats Per Minute (BPM)
Statistics for each planned time from baseline to day 29.
Measured: Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29
12-lead ECG PR Intervals
12-lead ECG PR intervals baseline and change from baseline at other timepoints in milliseconds.
Statistics for each planned time from baseline to day 29.
Measured: Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29
12-lead ECG QRS Intervals
12-lead ECG QRS intervals baseline and change from baseline at other time points in milliseconds
Statistics for each planned time from baseline to day 29.
Measured: Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29
12-lead ECG QTcF Intervals
12-lead ECG corrected heart rate (QT) interval, using Fridericia method (QTcF), baseline and change from baseline at other time points in milliseconds.
Statistics for each planned time from baseline to day 29.
Measured: Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29
12-lead ECG QTcB Intervals
12-lead ECG heart rate corrected QT interval, using Bazett method (QTcB), baseline and change from baseline at other time points in milliseconds.
Statistics for each planned time from baseline to day 29.
Measured: Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29
12-lead ECG QT Intervals
12-lead ECG QT intervals baseline and change from baseline at other time points in milliseconds.
Statistics for each planned time from baseline to day 29.
Measured: Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29
AUC (0-6H) FEV1 (Unsupervised), AUC (0-6H) PEFR (Unsupervised), FVC Peak (0-3h), AUC (6-12h) FEV1 (Unsupervised), AUC (6-12h) PEFR (Unsupervised), Individual PEFR Measurements (Supervised and Unsupervised), Individual PEFR Measurements (Unsupervised)
- AUC (0-6h) for FEV1, and PEFR (unsupervised) after first dose and after 2 and 4 weeks of treatment were not analysed in the study report because the pertinent information from the unsupervised Pulmonary Function Tests (PFTs) was for the time interval from 6 to 12 hours post-dosing.
- FVC peak 0-3h response after the first dose and at Week 2 (supervised) and AUC (6-12h) for FEV1 and PEFR after the first dose and at Week 2 (unsupervised) were not analysed in the study report.
- Individual PEFR (supervised) measurements and individual FEV1 and PEFR (unsupervised) measurements at each time point were not analysed in the study report.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionFeb 2009
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
- Who is masked
- Participant, Investigator
- Enrolment
- 141 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
- NCT00720499
- Sponsor's protocol ID
- 1237.9
- Other IDs
- EudtaCT No: 2008-000562-23
- Status last verified
- Jul 2015
- First submitted
- 21 Jul 2008
- Last updated
- 17 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Cross-over Study to Assess the Efficacy and Safety of 4 Weeks of Once Daily Treatment of 2 Doses of Orally Inhaled BI 1744 CL, Each in Fixed Dose Combination (FDC) With 5 Microgram Tiotropium Bromide (Delivered by the Respimat® Inhaler) in Patients With COPD
- ClinicalTrials.gov ID
- NCT00720499
- Acronym / sponsor ID
- 1237.9
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Feb 2009 (actual)
- First posted
- 22 Jul 2008 (estimated)
- Results
- Posted 17 Aug 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 determine the optimum dose(s) of BI 1744 CL administered with 5 microgram tiotropium bromide solution for inhalation, delivered by the Respimat® inhaler, once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 1744 CL low dose+tiotropium bromide | Experimental | Drug: BI 1744 CL plus tiotropium bromide, Device: Respimat® InhalerBI 1744 CL low dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation |
| BI 1744 CL medium dose+tiotropium bromide | Experimental | Drug: BI 1744 CL plus tiotropium bromide, Device: Respimat® InhalerBI 1744 CL medium dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions
- All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
- Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 >= 30% of predicted normal and <80% of predicted normal 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 (13 listed)
- Patients with a significant disease other than COPD
- Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis;
- Patients with a history of asthma or a total blood eosinophil count >= 600/mm3.
- Patients with any of the following conditions:a diagnosis of thyrotoxicosis, a diagnosis of paroxysmal tachycardia (>100 beats per minute), a marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTcF* interval > 450 ms), a history of additional risk factors for Torsade de Pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT Syndrome)
- Patients with any of the following conditions:a history of myocardial infarction within 1 year of screening visit (Visit 1), a diagnosis of clinically relevant cardiac arrhythmia, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, a history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis, a history of significant alcohol or drug abuse
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 1744 CL plus tiotropium bromideBI 1744 CL plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation | Drug | BI 1744 CL low dose+tiotropium bromide, BI 1744 CL medium dose+tiotropium bromide |
| Respimat® Inhaler | Device | BI 1744 CL low dose+tiotropium bromide, BI 1744 CL medium dose+tiotropium bromide |
Primary outcome
Trough Forced Expiratory Volume in One Second (FEV1) Response [L] After Four Weeks of Treatment.
Time frame: 1 hour (h), 10 minutes (min) before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29
Trough FEV1 was defined as the mean of the 2 FEV1 values at the end of the dosing interval, 24 hours post-drug administration. Response is defined as the change from baseline, baseline is defined as the mean of the 2 pre-treatment timepoints (-1 hour and -10 minutes) before first drug administration in each treatment period. The presented means are adjusted based on an ANCOVA with terms for baseline, treatment, centre, patient within centre and period (all effects fixed).
28 secondary outcomes
Trough FEV1 Response [L] After 2 Weeks of Treatment
Time frame: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 15
Individual FEV1 Measurements
Time frame: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29
FEV1 AUC 0-3h, Response
Time frame: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29
FEV1 Peak 0-3h Response
Time frame: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29
FEV1, AUC (0-6h) Response
Time frame: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29
FEV1 (Unsupervised) AUC (6-12h) Response
Time frame: 6 hours (h), 9h and 12h after drug administration on day 29
Trough FVC Response
Time frame: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 15, in addition 4h, 5h, 6h after drug administration on day 29
Individual FVC Measurements
Time frame: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29
FVC AUC (0-3h) Response
Time frame: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29
FVC AUC (0-6h) Response
Time frame: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29
FVC Peak 0-3h Response
Time frame: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on day 29
PEFR AUC (0-3h) Response
Time frame: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29
PEFR Peak 0-3h Response
Time frame: 1h, 10min before drug administration and 5min, 30min, 1h, 2h, 3h after drug administration on days 1, 15 and 29
PEFR AUC (6-12h) Response
Time frame: 1 hour (h) and 10 minutes before drug administration on day 1 and 6h, 9h and 12h after drug administration on day 29
Weekly Mean Morning PEFR
Time frame: Weeks 1,2,3 and 4
Weekly Mean Evening PEFR
Time frame: Weeks 1,2,3 and 4
Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (PRN Salbutamol [Albuterol])
Time frame: Weeks 1,2,3 and 4
Patient Global Rating
Time frame: 4 weeks
Physician's Global Evaluation
Time frame: Days 15 and 29
Clinically Significant Abnormalities for Blood Chemistry, Haematology, Urinalysis and Physical Examination
Time frame: 14 weeks
Overall Marked Changes From Baseline in Vital Signs
Time frame: Baseline to week 14
12-lead ECG Heart Rate
Time frame: Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29
12-lead ECG PR Intervals
Time frame: Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29
12-lead ECG QRS Intervals
Time frame: Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29
12-lead ECG QTcF Intervals
Time frame: Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29
12-lead ECG QTcB Intervals
Time frame: Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29
12-lead ECG QT Intervals
Time frame: Baseline, then 10min, 1h after drug administration on day 1, 30min before and 10min after drug administration on day 15, in addition 1h after drug administration on day 29
AUC (0-6H) FEV1 (Unsupervised), AUC (0-6H) PEFR (Unsupervised), FVC Peak (0-3h), AUC (6-12h) FEV1 (Unsupervised), AUC (6-12h) PEFR (Unsupervised), Individual PEFR Measurements (Supervised and Unsupervised), Individual PEFR Measurements (Unsupervised)
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Boehringer Ingelheim study chair
Boehringer Ingelheim
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 1744 CL plus tiotropium bromide and Respimat® Inhaler in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 24 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 13 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 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Germany, United States, Belgium, Canada. 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 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 17 Aug 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?
Trough Forced Expiratory Volume in One Second (FEV1) Response [L] After Four Weeks of Treatment. (time frame: 1 hour (h), 10 minutes (min) before drug administration and 5min, 30min, 1h, 2h, 3h, 4h, 5h, 6h after drug administration on day 29). 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 17 Aug 2015.