Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Japanese Patients With COPD

NCT ID: NCT00824382

Last Updated: 2014-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 328 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31

Brief 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). The selection of the optimum dose(s) will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BI 1744 CL 5 µg

2 puffs of 2.5 µg/actuation

Group Type: EXPERIMENTAL

BI 1744 CL 5 µg

Intervention Type: DRUG

2 puffs of 2.5 µg/actuation delivered by the Respimat® inhaler

BI 1744 CL 10 µg

2 puffs of 5 µg/actuation

Group Type: EXPERIMENTAL

BI 1744 CL 10 µg

Intervention Type: DRUG

2 puffs of 5 µg/actuation delivered by Respimat®

Placebo

2 puffs

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

2 puffs delivered by the Respimat® inhaler

BI 1744 CL 2 µg

2 puffs of 1 µg/actuation

Group Type: EXPERIMENTAL

BI 1744 CL 2 µg

Intervention Type: DRUG

2 puffs of 1 µg/actuation delivered by the Respimat® inhaler

Interventions

BI 1744 CL 2 µg

2 puffs of 1 µg/actuation delivered by the Respimat® inhaler

Intervention Type: DRUG

BI 1744 CL 5 µg

2 puffs of 2.5 µg/actuation delivered by the Respimat® inhaler

Intervention Type: DRUG

BI 1744 CL 10 µg

2 puffs of 5 µg/actuation delivered by Respimat®

Intervention Type: DRUG

Placebo

2 puffs delivered by the Respimat® inhaler

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. All patients must sign an informed consent consistent with GCP guidelines prior to participation in the trial.

2. 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

3. Male or female patients, 40 years of age or older

4. 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.

5. 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.

6. Patients must be able to inhale medication in a competent manner from the Respimat inhaler and from a MDI.

Exclusion Criteria

1. 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

2. 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)

3. 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

4. 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 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.

5. 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

6. 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)

7. 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.

8. 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

9. 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

10. Patients who have taken an investigational drug within 1 month or 6 half lives (whichever is greater) prior to screening visit

11. Patients with known hypersensitivity to beta-adrenergics drugs, BAC, EDTA or any other component of the Respimat inhalation solution delivery system

12. Pregnant or suspect of pregnant or women who are willing to become pregnant during the study period or nursing women

13. Patients who have previously been participated in this study or are currently participating in another study

14. Patients who are unable to comply with pulmonary medication restrictions prior to randomisation

15. 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Boehringer Ingelheim

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

1222.22.048 Boehringer Ingelheim Investigational Site

Asahikawa, Hokkaido, , Japan

1222.22.044 Boehringer Ingelheim Investigational Site

Bunkyo-ku, Tokyo, , Japan

1222.22.008 Boehringer Ingelheim Investigational Site

Chiba, Chiba, , Japan

1222.22.002 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, , Japan

1222.22.041 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, , Japan

1222.22.027 Boehringer Ingelheim Investigational Site

Himeji, Hyogo, , Japan

1222.22.028 Boehringer Ingelheim Investigational Site

Himeji, Hyogo, , Japan

1222.22.018 Boehringer Ingelheim Investigational Site

Hiroshima, Hiroshima, , Japan

1222.22.021 Boehringer Ingelheim Investigational Site

Hitachi, Ibaraki, , Japan

1222.22.010 Boehringer Ingelheim Investigational Site

Inashiki-gun, Ibaraki, , Japan

1222.22.012 Boehringer Ingelheim Investigational Site

Itabashi-ku, Tokyo, , Japan

1222.22.009 Boehringer Ingelheim Investigational Site

Kamogawa, Chiba, , Japan

1222.22.023 Boehringer Ingelheim Investigational Site

Kawasaki, Kanagawa, , Japan

1222.22.025 Boehringer Ingelheim Investigational Site

Kawasaki, Kanagawa, , Japan

1222.22.017 Boehringer Ingelheim Investigational Site

Kishiwada, Osaka, , Japan

1222.22.004 Boehringer Ingelheim Investigational Site

Kitakyusyu, Fukuoka, , Japan

1222.22.020 Boehringer Ingelheim Investigational Site

Koga, Fukuoka, , Japan

1222.22.014 Boehringer Ingelheim Investigational Site

Komaki, Aichi, , Japan

1222.22.032 Boehringer Ingelheim Investigational Site

Kumamoto, Kumamoto, , Japan

1222.22.005 Boehringer Ingelheim Investigational Site

Kurume, Fukuoka, , Japan

1222.22.029 Boehringer Ingelheim Investigational Site

Kurume, Fukuoka, , Japan

1222.22.033 Boehringer Ingelheim Investigational Site

Kyoto, Kyoto, , Japan

1222.22.050 Boehringer Ingelheim Investigational Site

Kyoto, Kyoto, , Japan

1222.22.022 Boehringer Ingelheim Investigational Site

Matsumoto, Nagano, , Japan

1222.22.015 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

1222.22.043 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, , Japan

1222.22.001 Boehringer Ingelheim Investigational Site

Naka-gun, Ibaraki, , Japan

1222.22.007 Boehringer Ingelheim Investigational Site

Niigata, Niigata, , Japan

1222.22.040 Boehringer Ingelheim Investigational Site

Obihiro, Hokkaido, , Japan

1222.22.042 Boehringer Ingelheim Investigational Site

Okinawa, Okinawa, , Japan

1222.22.034 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

1222.22.038 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

1222.22.049 Boehringer Ingelheim Investigational Site

Osaka, Osaka, , Japan

1222.22.045 Boehringer Ingelheim Investigational Site

Osaka-sayama, Osaka, , Japan

1222.22.019 Boehringer Ingelheim Investigational Site

Sakai, Oasaka, , Japan

1222.22.006 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, , Japan

1222.22.051 Boehringer Ingelheim Investigational Site

Sashima-gun, Ibaraki, , Japan

1222.22.031 Boehringer Ingelheim Investigational Site

Sendai, Miyagi, , Japan

1222.22.013 Boehringer Ingelheim Investigational Site

Seto, Aichi, , Japan

1222.22.024 Boehringer Ingelheim Investigational Site

Shibata-gun, Miyagi, , Japan

1222.22.003 Boehringer Ingelheim Investigational Site

Takarazuka, Hyogo, , Japan

1222.22.026 Boehringer Ingelheim Investigational Site

Tsukuba, Ibaraki, , Japan

1222.22.030 Boehringer Ingelheim Investigational Site

Ube, Yamaguchi, , Japan

1222.22.037 Boehringer Ingelheim Investigational Site

Uji, Kyoto, , Japan

1222.22.047 Boehringer Ingelheim Investigational Site

Wakayama, Wakayama, , Japan

1222.22.016 Boehringer Ingelheim Investigational Site

Yamagata, Yamagata, , Japan

1222.22.036 Boehringer Ingelheim Investigational Site

Yao, Osaka, , Japan

1222.22.011 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, , Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 26316741 (View on PubMed)

Other Identifiers

1222.22

Identifier Type: -

Identifier Source: org_study_id