Pulmonary Disease, Chronic ObstructivePhase 2NCT00824382
Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Japanese Patients With COPD
A Phase 2 study testing BI 1744 CL 2 µg, BI 1744 CL 5 µg and BI 1744 CL 10 µg in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 48 sites in Japan.
Trial summary
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat inhaler once daily for 4 weeks in Japanese 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 2 µg, BI 1744 CL 5 µg and BI 1744 CL 10 µg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 328 participants
- Where
- 48 sitesJapan
- Study dates
- Jan 2009to Mar 2010
- 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 GCP guidelines prior to participation in the trial.
- All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: Patients must have relatively stable, moderate to severe 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. Pack-Years = [Number of cigarettes/day/20] - years of smoking Patients who have never smoked cigarettes must be excluded.
- Patients must be able to perform technically acceptable pulmonary function tests (both supervised and unsupervised) and PEFR measurements, and must be able to record a patient 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 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 an AST >80 IU/L, ALT >80 IU/L, bilirubin >1.5 x ULN or creatinine >1.5 x ULN 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. A repeat eosinophil count will not be conducted in these patients
- Patients with any of the following conditions:
- a diagnosis of thyrotoxicosis
- a diagnosis of paroxysmal tachycardia (>100 beats per minute)
Show all 31Show fewer
- a marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval >450 ms) as recommended by ICH E14. For patients who have a QTc interval between 450 ms and 500 ms, as judged by site personnel, there will be a confirmatory reading by centralized evaluation institute. If the confirmatory reading is still greater than 450 ms, patient will be excluded. Patients with a QTc interval >=500 ms will immediately be excluded from the study.
- a history of additional risk factors for Torsade de Pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT Syndrome) as recommended by ICH E14.
- Patients with any of the following conditions:
- a history of myocardial infarction within 1 year
- a diagnosis of clinically relevant cardiac arrhythmia
- known active tuberculosis
- a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last 5 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 with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1)
- Patients being treated with any of the following concomitant medications:
- medications that prolong the QT/QTc interval
- oral beta-adrenergics and beta-adrenergics patchs
- beta-blockers (topical beta-blockers for ocular conditions are allowed)
- oral corticosteroid medication at unstable doses (i.e. less than 6 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 1 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 6 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 1 month or 6 half lives (whichever is greater) prior to screening visit
- Patients with known hypersensitivity to beta-adrenergics drugs, BAC, EDTA or any other component of the Respimat inhalation solution delivery system
- Pregnant or suspect of pregnant or women who are willing to become pregnant during the study period or nursing women
- Patients who have previously been participated in this study or are currently participating in another study
- Patients who are unable to comply with pulmonary medication restrictions prior to randomisation
- The randomization of patients with any respiratory infection or COPD exacerbation in the 6 weeks prior to the screening visit or during the screening period should be postponed. Patients may be randomised 6 weeks following recovery from the infection or exacerbation
Trial locations and contacts
48 sites in 1 country.
48 sites in 1 country
Japan48 sites
1222.22.048 Boehringer Ingelheim Investigational Site
Asahikawa, Hokkaido
1222.22.044 Boehringer Ingelheim Investigational Site
Bunkyo-ku, Tokyo
1222.22.008 Boehringer Ingelheim Investigational Site
Chiba, Chiba
1222.22.002 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka
1222.22.041 Boehringer Ingelheim Investigational Site
Fukuoka, Fukuoka
1222.22.027 Boehringer Ingelheim Investigational Site
Himeji, Hyogo
1222.22.028 Boehringer Ingelheim Investigational Site
Himeji, Hyogo
1222.22.018 Boehringer Ingelheim Investigational Site
Hiroshima, Hiroshima
1222.22.021 Boehringer Ingelheim Investigational Site
Hitachi, Ibaraki
1222.22.010 Boehringer Ingelheim Investigational Site
Inashiki-gun, Ibaraki
1222.22.012 Boehringer Ingelheim Investigational Site
Itabashi-ku, Tokyo
1222.22.009 Boehringer Ingelheim Investigational Site
Kamogawa, Chiba
1222.22.023 Boehringer Ingelheim Investigational Site
Kawasaki, Kanagawa
1222.22.025 Boehringer Ingelheim Investigational Site
Kawasaki, Kanagawa
1222.22.017 Boehringer Ingelheim Investigational Site
Kishiwada, Osaka
1222.22.004 Boehringer Ingelheim Investigational Site
Kitakyusyu, Fukuoka
1222.22.020 Boehringer Ingelheim Investigational Site
Koga, Fukuoka
1222.22.014 Boehringer Ingelheim Investigational Site
Komaki, Aichi
1222.22.032 Boehringer Ingelheim Investigational Site
Kumamoto, Kumamoto
1222.22.005 Boehringer Ingelheim Investigational Site
Kurume, Fukuoka
1222.22.029 Boehringer Ingelheim Investigational Site
Kurume, Fukuoka
1222.22.033 Boehringer Ingelheim Investigational Site
Kyoto, Kyoto
1222.22.050 Boehringer Ingelheim Investigational Site
Kyoto, Kyoto
1222.22.022 Boehringer Ingelheim Investigational Site
Matsumoto, Nagano
1222.22.015 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1222.22.043 Boehringer Ingelheim Investigational Site
Nagoya, Aichi
1222.22.001 Boehringer Ingelheim Investigational Site
Naka-gun, Ibaraki
1222.22.007 Boehringer Ingelheim Investigational Site
Niigata, Niigata
1222.22.040 Boehringer Ingelheim Investigational Site
Obihiro, Hokkaido
1222.22.042 Boehringer Ingelheim Investigational Site
Okinawa, Okinawa
1222.22.045 Boehringer Ingelheim Investigational Site
Osaka-sayama, Osaka
1222.22.034 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1222.22.038 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1222.22.049 Boehringer Ingelheim Investigational Site
Osaka, Osaka
1222.22.019 Boehringer Ingelheim Investigational Site
Sakai, Oasaka
1222.22.006 Boehringer Ingelheim Investigational Site
Sapporo, Hokkaido
1222.22.051 Boehringer Ingelheim Investigational Site
Sashima-gun, Ibaraki
1222.22.031 Boehringer Ingelheim Investigational Site
Sendai, Miyagi
1222.22.013 Boehringer Ingelheim Investigational Site
Seto, Aichi
1222.22.024 Boehringer Ingelheim Investigational Site
Shibata-gun, Miyagi
1222.22.003 Boehringer Ingelheim Investigational Site
Takarazuka, Hyogo
1222.22.026 Boehringer Ingelheim Investigational Site
Tsukuba, Ibaraki
1222.22.030 Boehringer Ingelheim Investigational Site
Ube, Yamaguchi
1222.22.037 Boehringer Ingelheim Investigational Site
Uji, Kyoto
1222.22.047 Boehringer Ingelheim Investigational Site
Wakayama, Wakayama
1222.22.016 Boehringer Ingelheim Investigational Site
Yamagata, Yamagata
1222.22.036 Boehringer Ingelheim Investigational Site
Yao, Osaka
1222.22.011 Boehringer Ingelheim Investigational Site
Yokohama, Kanagawa
About this study
Official title: Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL Delivered by the Respimat Inhaler in Japanese Patients With COPD
The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat inhaler once daily for 4 weeks in Japanese patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- BI 1744 CL 2 µg, BI 1744 CL 5 µg, BI 1744 CL 10 µg, Placebo
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 1744 CL 2 µgDrug
2 puffs of 1 µg/actuation delivered by the Respimat® inhaler
BI 1744 CL 5 µgDrug
2 puffs of 2.5 µg/actuation delivered by the Respimat® inhaler
BI 1744 CL 10 µgDrug
2 puffs of 5 µg/actuation delivered by Respimat®
PlaceboDrug
2 puffs delivered by the Respimat® inhaler
| Study group | Role | What they receive |
|---|---|---|
| BI 1744 CL 5 µg | Experimental | 2 puffs of 2.5 µg/actuation Receives: Drug: BI 1744 CL 5 µg |
| BI 1744 CL 10 µg | Experimental | 2 puffs of 5 µg/actuation Receives: Drug: BI 1744 CL 10 µg |
| Placebo | Placebo comparator | 2 puffs Receives: Drug: Placebo |
| BI 1744 CL 2 µg | Experimental | 2 puffs of 1 µg/actuation Receives: Drug: BI 1744 CL 2 µg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough FEV1 Response at Week 4
The change from baseline in trough FEV1 after 4 weeks of treatment. Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to next test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline . Baseline trough FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 prior to administration of the first dose of study medication.
Measured: baseline and after 4 weeks treatment
Secondary outcomes (17)
Trough FEV1 Response at Week 2
Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to next test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline trough FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 prior to administration of the first dose of study medication
Measured: baseline and after 2 weeks treatment
FEV1 AUC(0-3) Response at 4 Weeks
The change from baseline in FEV1 AUC(0-3) after 4 weeks of treatment. FEV1 AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in liters.
Due to normalization the unit is liters.
Measured: baseline and after 4 weeks treatment
FEV1 Peak(0-3) Response at 4 Weeks
The change from baseline in FEV1 peak(0-3) after 4 weeks of treatment.
Measured: baseline and after 4 weeks treatment
Trough FVC Response at Week 4
The change from baseline in Trough FVC after 4 weeks of treatment
Measured: baseline and after 4 weeks treatment
FVC AUC(0-3) Response
The change from baseline in FVC AUC(0-3) response after 4 weeks of treatment. FVC AUC 0-3h was calculated from 0-3 hours post-dose using the trapezoidal rule, divided by the observation time (3h) to report in liters.
Due to normalization the unit is liters.
Measured: baseline and after 4 weeks treatment
FVC Peak(0-3) Response
The change from baseline in FVC peak(0-3) response after 4 weeks of treatment.
Measured: baseline and after 4 weeks treatment
Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 0-6h (AUC 0-6h) Response After 4 Weeks
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect.
FEV1 AUC 0-6h was calculated from 0-6 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in liters.
Measured: baseline and after 4weeks treatment
Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 4 Weeks
Response was defined as change from baseline. Study baseline FEV1 was defined as the mean of the available pre-dose FEV1 values prior to the first dose of randomized treatment. Means are adjusted using a model with treatment (trt), baseline as fixed effects and centre as random effect.
FEV1 AUC 6-12h was calculated from 6-12 hours post-dose using the trapezoidal rule, divided by the observation time (6h) to report in liters.
Measured: Baseline and after 4weeks treatment
Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) After 4 Weeks
PEFR measurements were recorded by means of a patient diary on a daily basis. This diary was used to record the twice daily PEFs,
Morning measurements were performed immediately upon arising before administration of trial and/or rescue medication.The highest of three readings for each measurement were recorded.
Measured: Week 4
Weekly Mean Evening PEFR After 4 Weeks
PEFR measurements were recorded by means of a patient diary on a daily basis. This diary was used to record the twice daily PEFs,
Evening measurements were performed at bedtime.The highest of three readings for each measurement were recorded.
Measured: Week 4
Weekly Mean Number of Occasions of Rescue Therapy After 4 Weeks
Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol )
Measured: Week 4
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical Examination
Clinical relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical examination. New abnormal findings or worsenings of baseline conditions were reported as Adverse Events related to treatment (cardiac disorders and investigations).
Measured: 4 weeks
Difference From Baseline in Potassium
Difference from baseline in Potassium (normalized values). Normalization means that the values from different laboratories are transformed in such a way that they are directly comparable.
Measured: Baseline, Week 4
Cmax (Maximum Measured Concentration of the Analyte in Plasma)
Cmax only calculated if >1/3 of the patients have available pharmacokinetic parameters,thus not applicable for the Olodaterol 2 mcg
Measured: after first inhalated administration
Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State)
Cmax,ss only calculated if >1/3 of the patients have available pharmacokinetic parameters, thus not applicable for the Olodaterol 2 mcg
Measured: visit at week 4
AUC0-1
Area under the concentration curve from 0 to 1 hour using trapezoid rule, only calculated if >1/3 of the patients have available pharmacokinetic parameters,thus not applicable for Olodaterol 2mcg group
Measured: after first inhalated administration
AUC0-1,ss
Area under the concentration curve from 0 to 1 hour at steady state using trapezoid rule, only calculated if >1/3 of the patients have available pharmacokinetic parameters, thus not applicable for Olodaterol 2mcg group
Measured: visit at week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionMar 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824382
- Sponsor's protocol ID
- 1222.22
- Status last verified
- May 2014
- First submitted
- 15 Jan 2009
- Last updated
- 27 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Ichinose M, Takizawa A, Izumoto T, Tadayasu Y, Hamilton AL, Kunz C, Fukuchi Y. Efficacy and safety of the long-acting beta2-agonist olodaterol over 4 weeks in Japanese patients with chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2015 Aug 20;10:1673-83. doi: 10.2147/COPD.S86002. eCollection 2015.
PubMed 26316741
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL Delivered by the Respimat Inhaler in Japanese Patients With COPD
- ClinicalTrials.gov ID
- NCT00824382
- Acronym / sponsor ID
- 1222.22
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Mar 2010 (actual)
- First posted
- 16 Jan 2009 (estimated)
- Results
- Posted 10 Jun 2014
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 inhalation solution delivered by the Respimat inhaler once daily for 4 weeks in Japanese patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BI 1744 CL 5 µg | Experimental | Drug: BI 1744 CL 5 µg2 puffs of 2.5 µg/actuation |
| BI 1744 CL 10 µg | Experimental | Drug: BI 1744 CL 10 µg2 puffs of 5 µg/actuation |
| Placebo | Placebo comparator | Drug: Placebo2 puffs |
| BI 1744 CL 2 µg | Experimental | Drug: BI 1744 CL 2 µg2 puffs of 1 µg/actuation |
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 GCP guidelines prior to participation in the trial.
- All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria: Patients must have relatively stable, moderate to severe 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. Pack-Years = [Number of cigarettes/day/20] - years of smoking Patients who have never smoked cigarettes must be excluded.
- Patients must be able to perform technically acceptable pulmonary function tests (both supervised and unsupervised) and PEFR measurements, and must be able to record a patient diary during the study period as required in the protocol.
Key exclusion criteria (31 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 an AST >80 IU/L, ALT >80 IU/L, bilirubin >1.5 x ULN or creatinine >1.5 x ULN 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. A repeat eosinophil count will not be conducted in these patients
- 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 2 µg2 puffs of 1 µg/actuation delivered by the Respimat® inhaler | Drug | BI 1744 CL 2 µg |
| BI 1744 CL 5 µg2 puffs of 2.5 µg/actuation delivered by the Respimat® inhaler | Drug | BI 1744 CL 5 µg |
| BI 1744 CL 10 µg2 puffs of 5 µg/actuation delivered by Respimat® | Drug | BI 1744 CL 10 µg |
| Placebo2 puffs delivered by the Respimat® inhaler | Drug | Placebo |
Primary outcome
Trough FEV1 Response at Week 4
Time frame: baseline and after 4 weeks treatment
The change from baseline in trough FEV1 after 4 weeks of treatment. Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to next test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline . Baseline trough FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 prior to administration of the first dose of study medication.
17 secondary outcomes
Trough FEV1 Response at Week 2
Time frame: baseline and after 2 weeks treatment
FEV1 AUC(0-3) Response at 4 Weeks
Time frame: baseline and after 4 weeks treatment
FEV1 Peak(0-3) Response at 4 Weeks
Time frame: baseline and after 4 weeks treatment
Trough FVC Response at Week 4
Time frame: baseline and after 4 weeks treatment
FVC AUC(0-3) Response
Time frame: baseline and after 4 weeks treatment
FVC Peak(0-3) Response
Time frame: baseline and after 4 weeks treatment
Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 0-6h (AUC 0-6h) Response After 4 Weeks
Time frame: baseline and after 4weeks treatment
Forced Expiratory Volume in 1 Second (FEV1) (Unsupervised) Area Under Curve 6-12 h (AUC 6-12h) Response After 4 Weeks
Time frame: Baseline and after 4weeks treatment
Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR) After 4 Weeks
Time frame: Week 4
Weekly Mean Evening PEFR After 4 Weeks
Time frame: Week 4
Weekly Mean Number of Occasions of Rescue Therapy After 4 Weeks
Time frame: Week 4
Clinical Relevant Abnormalities for Vital Signs, Blood Chemistry, Haematology, Urinalysis, ECG and Physical Examination
Time frame: 4 weeks
Difference From Baseline in Potassium
Time frame: Baseline, Week 4
Cmax (Maximum Measured Concentration of the Analyte in Plasma)
Time frame: after first inhalated administration
Cmax,ss (Maximum Measured Concentration of the Analyte in Plasma at Steady State)
Time frame: visit at week 4
AUC0-1
Time frame: after first inhalated administration
AUC0-1,ss
Time frame: visit at week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26316741Ichinose M, Takizawa A, Izumoto T, Tadayasu Y, Hamilton AL, Kunz C, Fukuchi Y. Efficacy and safety of the long-acting beta2-agonist olodaterol over 4 weeks in Japanese patients with chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2015 Aug 20;10:1673-83. doi: 10.2147/COPD.S86002. eCollection 2015.
- 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
48 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 1744 CL 2 µg, BI 1744 CL 5 µg and BI 1744 CL 10 µg in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 48 sites in Japan.
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 31 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 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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 10 Jun 2014). 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 FEV1 Response at Week 4 (time frame: baseline and after 4 weeks treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00824382, which also lists 1 linked publication.
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 27 Jun 2014.