Pulmonary Disease, Chronic ObstructivePhase 1NCT02231177
Pharmacokinetics and Safety of BI 1744 CL Plus Tiotropium Bromide in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 1 study testing BI 1744 CL, BI 1744 CL/Tiotropium FDC and Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
Trial summary
The purpose of this study is to compare the systemic exposure to BI 1744 BS and tiotropium at steady state following inhalation of the fixed dose combination (FDC) of 10 μg BI 1744 CL plus 5 μg tiotropium bromide with the systemic exposure to BI 1744 BS and tiotropium at steady state following inhalation of the single… 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, BI 1744 CL/Tiotropium FDC and Tiotropium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Nov 2008
- 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 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 International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) guidelines and local legislations prior to any study-related procedures, which includes medication washout and restrictions
- All 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 forced expiratory volume in one second (FEV1) ≥ 30 % of predicted normal and < 80% of predicted normal and a post-bronchodilator FEV1 / forced vital capacity (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 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 inhalator (MDI)
Who cannot join
- Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study
- Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis; all patients with a serum glutamic oxaloacetic transaminase (SGOT) > 2.5 x ULN, serum glutamic pyruvic transaminase (SGPT) > 2.5 x ULN, bilirubin >2x upper limit of normal (ULN), creatinine >2 x ULN or creatinine clearance < 50 mL/min (Estimation of Glomerular Filtration Rate (GFR) by using the Cockcroft-Gault Formula) will be excluded regardless of clinical condition (a repeat laboratory evaluation will not be conducted in these patients)
- 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)
Show all 33Show fewer
- a marked baseline prolongation of QT/QTc interval
- a history of additional risk factors for Torsade de Pointes (TdP) (e.g. heart failure, hypokalaemia, 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 cardiac arrhythmia, arterial hypertension or coronary heart disease
- known active tuberculosis
- a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed)
- 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
- Patients being treated with any of the following concomitant medications:
- medications that prolong the QT/QTc interval since the effects of BI 1744 CL on QT/QTc interval have yet to be fully characterized
- oral β-adrenergics
- β-blockers (topical β -blockers for ocular conditions are allowed)
- oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
- 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
- Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program
- Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1)
- Patients with known hypersensitivity to β-adrenergics and/or anticholinergic drugs, benzalkonium chloride, ethylenediaminetetraacetic acid or any other component of the Respimat® inhalation solution delivery system
- Pregnant or nursing women
- Women of childbearing potential not using two highly effective methods of birth control (one barrier and one non-barrier). Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner. 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
- According to Inclusion Criterion No. 2, patients with a post-bronchodilator FEV1 of < 30% of predicted normal will always be excluded. Patients with a post-bronchodilator FEV1 between 30 and 50% of predicted normal will be excluded from the study, if they display additional symptoms of chronic respiratory insufficiency or right ventricular insufficiency
- Patients with narrow angle glaucoma, prostate hyperplasia, or bladder neck obstruction
About this study
Official title: A Randomised, Double-blind, 3-way Crossover Study to Compare Pharmacokinetics and Safety of 10 μg BI 1744 CL Plus 5 μg Tiotropium Bromide Given as Fixed Dose Combination Via the Respimat® Inhaler With the Pharmacokinetics and the Safety of the Single Agents, i.e. 10 μg BI 1744 CL and 5 μg Tiotropium Bromide, Delivered Via the Respimat® Inhaler Following 21 Day-treatment Periods in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to compare the systemic exposure to BI 1744 BS and tiotropium at steady state following inhalation of the fixed dose combination (FDC) of 10 μg BI 1744 CL plus 5 μg tiotropium bromide with the systemic exposure to BI 1744 BS and tiotropium at steady state following inhalation of the single agents, i.e., 10 μg BI 1744 CL and 5 μg tiotropium bromide, when administered once-daily via the Respimat® Inhaler for 21 days.
The secondary objectives were to compare the safety and tolerability (adverse events, 12-lead electrocardiogram recordings, pulmonary function testing) of BI 1744 CL and tiotropium bromide when administered as fixed dose combination or as single-agent therapy.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- BI 1744 CL, BI 1744 CL/Tiotropium FDC, Tiotropium
- 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 CLDrug
BI 1744 CL/Tiotropium FDCDrug
TiotropiumDrug
| Study group | Role | What they receive |
|---|---|---|
| BI 1744 CL/Tiotropium FDC | Experimental | Not described Receives: Drug: BI 1744 CL/Tiotropium FDC |
| BI 1744 CL | Active comparator | Not described Receives: Drug: BI 1744 CL |
| Tiotropium | Active comparator | Not described Receives: Drug: Tiotropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-1h,ss) of Olodaterol
Area under the concentration time curve of Olodaterol in plasma over the time interval t1=0 to t2=1 hour at steady state (AUC(0-1h,ss)).
As plasma concentrations were not expected to be quantifiable over the complete dosing interval in all patients, t2 was defined as the time-point where at least 2/3 of the patients reveal quantifiable plasma concentrations of Olodaterol. Based on the given definition AUC(0-1h,ss) was selected as primary endpoint.
The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA).
Measured: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
Cmax,ss of Olodaterol
Maximum measured concentration of Olodaterol in plasma at steady state (Cmax,ss).
The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA).
Measured: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
Ae(0-24h,ss) of Tiotropium
Amount of Tiotropium that was eliminated in urine at steady state from time point 0 to 24 h post-inhalation (Ae(0-24h,ss)).
The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA).
Measured: Intervals 0-4, 4-8, 8-12 and 12-24 hours on Day 21 of the actual treatment period.
Secondary outcomes (20)
Ae(0-24h,ss) of Olodaterol
Amount of Olodaterol that was eliminated in urine at steady state from time point 0 to 24 h post-inhalation (Ae(0-24h,ss)).
The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA).
Measured: Intervals 0-4, 4-8, 8-12 and 12-24 hours on Day 21 of the actual treatment period.
AUC(0-6h,ss) of Tiotropium
Area under the concentration time curve of Tiotropium in plasma over the time interval t1=0 to t2=6 h at steady state (AUC(0-6h,ss)).
As plasma concentrations were not expected to be quantifiable over the complete dosing interval in all patients, t2 was defined as the time-point where at least 2/3 of the patients reveal quantifiable plasma concentrations of Tiotropium. Based on the given definition AUC(0-6h,ss) was selected as secondary endpoint.
The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA).
Measured: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
Cmax,ss of Tiotropium
Maximum measured concentration of Tiotropium in plasma at steady state (Cmax,ss).
The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA).
Measured: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
AUC(0-2h,ss) of Olodaterol
Area under the concentration time curve of Olodaterol in plasma over the time interval 0 to 2 hours at steady state (AUC(0-2h,ss)).
The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA).
Measured: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
AUC(0-4h,ss) of Tiotropium
Area under the concentration time curve of Tiotropium in plasma over the time interval t1=0 to t2=4 h at steady state (AUC(0-4h,ss)).
The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA).
Measured: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
AUC(0-tz,ss) of Olodaterol
Area under the plasma concentration-time curve at steady state over the time interval from 0 to the time of the last quantifiable data point (AUC(0-tz)) for Olodaterol.
The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA).
Measured: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
AUC(0-tz,ss) of Tiotropium
Area under the plasma concentration-time curve at steady state over the time interval from 0 to the time of the last quantifiable data point (AUC(0-tz)) for Tiotropium.
The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA).
Measured: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
Tmax,ss of Olodaterol
Time from dosing to the maximum concentration of Olodaterol in plasma at steady state (tmax,ss).
Measured: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
Tmax,ss of Tiotropium
Time from dosing to the maximum concentration of Tiotropium in plasma at steady state (tmax,ss).
Measured: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
fe(0-24,ss) of Olodaterol
Fraction of Olodaterol eliminated in urine from 0 to 24 hours at steady state (fe(0-24,ss)).
The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics.
Measured: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
fe(0-24,ss) of Tiotropium
Fraction of Tiotropium eliminated in urine from 0 to 24 hours at steady state (fe(0-24,ss)).
The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics.
Measured: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
Cmin,ss of Olodaterol
Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).
The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics.
Measured: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
Cmin,ss of Tiotropium
Minimum concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).
The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics.
Measured: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
Tmin,ss of Olodaterol
Time from last dosing to the minimum concentration of the analyte in plasma at steady state over a uniform dosing interval (tmin,ss)
Measured: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
Tmin,ss of Tiotropium
Time from last dosing to the minimum concentration of the analyte in plasma at steady state over a uniform dosing interval (tmin,ss)
Measured: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
Concentration of Olodaterol in Plasma
Concentration of the analyte in plasma at 0.333 hours (20 minutes) after the 8th, 14th and 21st dose, C(0.333_8), C(0.333_14,ss) and C(0.333_21,ss) respectively. As steady state was anticipated to be reached by day 14 at the latest, the index 'ss' was used for days 14 and 21.
The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics.
Measured: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
Concentration of Tiotropium in Plasma
Concentration of the analyte in plasma at 0.333 hours (20 minutes) after the 8th, 14th and 21st dose, C(0.333_8), C(0.333_14,ss) and C(0.333_21,ss) respectively. As steady state was anticipated to be reached by day 14 at the latest, the index 'ss' was used for days 14 and 21.
The displayed values show gMeans and inter-subject variabilities calculated from descriptive statistics.
Measured: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
FVC Change From Baseline
Mean change from baseline in forced vital capacity (FVC). Pulmonary function test.
The baseline value was measured pre-dose on day 1 of the first treatment period.
Measured: 0:30 and 1:00 h after drug administration on the first day of each treatment period
FEV1 Change From Baseline
Mean change from baseline in forced expiratory volume in one second (FEV1). Pulmonary function test.
The baseline value was measured pre-dose on day 1 of the first treatment period.
Measured: 0:30 and 1:00 h after drug administration on the first day of each treatment period
Clinical Relevant Abnormalities in Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG
Clinically relevant abnormalities in vital signs (blood pressure and pulse rate), physical examination, blood chemistry, haematology, urinanalysis and ECG. New abnormal findings or worsening of baseline conditions were reported as Adverse Events. Any adverse events which occurred within 14 days following the last drug administration were assigned to the last study treatment administered.
Measured: From drug administration until 14 days following the last drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startJun 2008
- Primary completionNov 2008
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
- Crossover
- Masking
- Double blind
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231177
- Sponsor's protocol ID
- 1237.3
- Status last verified
- Dec 2015
- First submitted
- 2 Sep 2014
- Last updated
- 7 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, 3-way Crossover Study to Compare Pharmacokinetics and Safety of 10 μg BI 1744 CL Plus 5 μg Tiotropium Bromide Given as Fixed Dose Combination Via the Respimat® Inhaler With the Pharmacokinetics and the Safety of the Single Agents, i.e. 10 μg BI 1744 CL and 5 μg Tiotropium Bromide, Delivered Via the Respimat® Inhaler Following 21 Day-treatment Periods in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02231177
- Acronym / sponsor ID
- 1237.3
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Nov 2008 (actual)
- First posted
- 4 Sep 2014 (estimated)
- Results
- Posted 7 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the systemic exposure to BI 1744 BS and tiotropium at steady state following inhalation of the fixed dose combination (FDC) of 10 μg BI 1744 CL plus 5 μg tiotropium bromide with the systemic exposure to BI 1744 BS and tiotropium at steady state following inhalation of the single agents, i.e., 10 μg BI 1744 CL and 5 μg tiotropium bromide, when administered once-daily via the Respimat® Inhaler for 21 days.
The secondary objectives were to compare the safety and tolerability (adverse events, 12-lead electrocardiogram recordings, pulmonary function testing) of BI 1744 CL and tiotropium bromide when administered as fixed dose combination or as single-agent therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BI 1744 CL/Tiotropium FDC | Experimental | Drug: BI 1744 CL/Tiotropium FDC |
| BI 1744 CL | Active comparator | Drug: BI 1744 CL |
| Tiotropium | Active comparator | Drug: Tiotropium |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients must sign an informed consent consistent with International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP) guidelines and local legislations prior to any study-related procedures, which includes medication washout and restrictions
- All 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 forced expiratory volume in one second (FEV1) ≥ 30 % of predicted normal and < 80% of predicted normal and a post-bronchodilator FEV1 / forced vital capacity (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 during the study period as required in the protocol
Key exclusion criteria (33 listed)
- Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study
- Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis; all patients with a serum glutamic oxaloacetic transaminase (SGOT) > 2.5 x ULN, serum glutamic pyruvic transaminase (SGPT) > 2.5 x ULN, bilirubin >2x upper limit of normal (ULN), creatinine >2 x ULN or creatinine clearance < 50 mL/min (Estimation of Glomerular Filtration Rate (GFR) by using the Cockcroft-Gault Formula) will be excluded regardless of clinical condition (a repeat laboratory evaluation will not be conducted in these patients)
- Patients with a history of asthma or a total blood eosinophil count ≥600/mm3
- Patients with any of the following conditions:
- Patients with any of the following conditions:
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 | Drug | BI 1744 CL |
| BI 1744 CL/Tiotropium FDC | Drug | BI 1744 CL/Tiotropium FDC |
| Tiotropium | Drug | Tiotropium |
Primary outcome
AUC(0-1h,ss) of Olodaterol
Time frame: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
Area under the concentration time curve of Olodaterol in plasma over the time interval t1=0 to t2=1 hour at steady state (AUC(0-1h,ss)). As plasma concentrations were not expected to be quantifiable over the complete dosing interval in all patients, t2 was defined as the time-point where at least 2/3 of the patients reveal quantifiable plasma concentrations of Olodaterol. Based on the given definition AUC(0-1h,ss) was selected as primary endpoint. The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA).
Cmax,ss of Olodaterol
Time frame: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
Maximum measured concentration of Olodaterol in plasma at steady state (Cmax,ss). The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA).
Ae(0-24h,ss) of Tiotropium
Time frame: Intervals 0-4, 4-8, 8-12 and 12-24 hours on Day 21 of the actual treatment period.
Amount of Tiotropium that was eliminated in urine at steady state from time point 0 to 24 h post-inhalation (Ae(0-24h,ss)). The displayed values show adjusted gMeans and intra-subject variabilities calculated from the statistical model (ANOVA).
20 secondary outcomes
Ae(0-24h,ss) of Olodaterol
Time frame: Intervals 0-4, 4-8, 8-12 and 12-24 hours on Day 21 of the actual treatment period.
AUC(0-6h,ss) of Tiotropium
Time frame: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
Cmax,ss of Tiotropium
Time frame: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
AUC(0-2h,ss) of Olodaterol
Time frame: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
AUC(0-4h,ss) of Tiotropium
Time frame: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
AUC(0-tz,ss) of Olodaterol
Time frame: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
AUC(0-tz,ss) of Tiotropium
Time frame: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
Tmax,ss of Olodaterol
Time frame: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
Tmax,ss of Tiotropium
Time frame: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
fe(0-24,ss) of Olodaterol
Time frame: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
fe(0-24,ss) of Tiotropium
Time frame: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
Cmin,ss of Olodaterol
Time frame: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
Cmin,ss of Tiotropium
Time frame: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
Tmin,ss of Olodaterol
Time frame: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
Tmin,ss of Tiotropium
Time frame: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
Concentration of Olodaterol in Plasma
Time frame: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
Concentration of Tiotropium in Plasma
Time frame: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.
FVC Change From Baseline
Time frame: 0:30 and 1:00 h after drug administration on the first day of each treatment period
FEV1 Change From Baseline
Time frame: 0:30 and 1:00 h after drug administration on the first day of each treatment period
Clinical Relevant Abnormalities in Vital Signs, Physical Examination, Blood Chemistry, Haematology, Urinanalysis and ECG
Time frame: From drug administration until 14 days following the last drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2016.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 1744 CL, BI 1744 CL/Tiotropium FDC and Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim.
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 6 inclusion and 33 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 7 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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 7 Jan 2016). 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?
AUC(0-1h,ss) of Olodaterol (time frame: Within 30 min before drug administration and 0:02, 0:05, 0:10, 0:15, 0:20, 0:40, 1:00, 2:00, 4:00, 6:00, 8:00, 12:00, 24:00 hours after drug administration on Day 21 of the actual treatment period.). The study lists 3 primary outcomes in all. 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 7 Jan 2016.