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

NCT00824382 | Completed Phase 2 Results

• 1 other identifier: 1222.22
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 48

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

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and after 4 weeks treatment

Secondary Outcomes (17)

• Trough FEV1 Response at Week 2

  baseline and after 2 weeks treatment

• FEV1 AUC(0-3) Response at 4 Weeks

  baseline and after 4 weeks treatment

• FEV1 Peak(0-3) Response at 4 Weeks

  baseline and after 4 weeks treatment

• Trough FVC Response at Week 4

  baseline and after 4 weeks treatment

• FVC AUC(0-3) Response

  baseline and after 4 weeks treatment

Study Arms (4)

BI 1744 CL 5 µg

EXPERIMENTAL

2 puffs of 2.5 µg/actuation

Drug: BI 1744 CL 5 µg

BI 1744 CL 10 µg

EXPERIMENTAL

2 puffs of 5 µg/actuation

Drug: BI 1744 CL 10 µg

Placebo

PLACEBO COMPARATOR

2 puffs

Drug: Placebo

BI 1744 CL 2 µg

EXPERIMENTAL

2 puffs of 1 µg/actuation

Drug: BI 1744 CL 2 µg

Interventions

BI 1744 CL 2 µg DRUG

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

BI 1744 CL 2 µg

BI 1744 CL 5 µg DRUG

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

BI 1744 CL 5 µg

BI 1744 CL 10 µg DRUG

2 puffs of 5 µg/actuation delivered by Respimat®

BI 1744 CL 10 µg

Placebo DRUG

2 puffs delivered by the Respimat® inhaler

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (48)

1222.22.048 Boehringer Ingelheim Investigational Site

Asahikawa, Hokkaido, Japan

Location

1222.22.044 Boehringer Ingelheim Investigational Site

Bunkyo-ku, Tokyo, Japan

Location

1222.22.008 Boehringer Ingelheim Investigational Site

Chiba, Chiba, Japan

Location

1222.22.002 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, Japan

Location

1222.22.041 Boehringer Ingelheim Investigational Site

Fukuoka, Fukuoka, Japan

Location

1222.22.027 Boehringer Ingelheim Investigational Site

Himeji, Hyogo, Japan

Location

1222.22.028 Boehringer Ingelheim Investigational Site

Himeji, Hyogo, Japan

Location

1222.22.018 Boehringer Ingelheim Investigational Site

Hiroshima, Hiroshima, Japan

Location

1222.22.021 Boehringer Ingelheim Investigational Site

Hitachi, Ibaraki, Japan

Location

1222.22.010 Boehringer Ingelheim Investigational Site

Inashiki-gun, Ibaraki, Japan

Location

1222.22.012 Boehringer Ingelheim Investigational Site

Itabashi-ku, Tokyo, Japan

Location

1222.22.009 Boehringer Ingelheim Investigational Site

Kamogawa, Chiba, Japan

Location

1222.22.023 Boehringer Ingelheim Investigational Site

Kawasaki, Kanagawa, Japan

Location

1222.22.025 Boehringer Ingelheim Investigational Site

Kawasaki, Kanagawa, Japan

Location

1222.22.017 Boehringer Ingelheim Investigational Site

Kishiwada, Osaka, Japan

Location

1222.22.004 Boehringer Ingelheim Investigational Site

Kitakyusyu, Fukuoka, Japan

Location

1222.22.020 Boehringer Ingelheim Investigational Site

Koga, Fukuoka, Japan

Location

1222.22.014 Boehringer Ingelheim Investigational Site

Komaki, Aichi, Japan

Location

1222.22.032 Boehringer Ingelheim Investigational Site

Kumamoto, Kumamoto, Japan

Location

1222.22.005 Boehringer Ingelheim Investigational Site

Kurume, Fukuoka, Japan

Location

1222.22.029 Boehringer Ingelheim Investigational Site

Kurume, Fukuoka, Japan

Location

1222.22.033 Boehringer Ingelheim Investigational Site

Kyoto, Kyoto, Japan

Location

1222.22.050 Boehringer Ingelheim Investigational Site

Kyoto, Kyoto, Japan

Location

1222.22.022 Boehringer Ingelheim Investigational Site

Matsumoto, Nagano, Japan

Location

1222.22.015 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1222.22.043 Boehringer Ingelheim Investigational Site

Nagoya, Aichi, Japan

Location

1222.22.001 Boehringer Ingelheim Investigational Site

Naka-gun, Ibaraki, Japan

Location

1222.22.007 Boehringer Ingelheim Investigational Site

Niigata, Niigata, Japan

Location

1222.22.040 Boehringer Ingelheim Investigational Site

Obihiro, Hokkaido, Japan

Location

1222.22.042 Boehringer Ingelheim Investigational Site

Okinawa, Okinawa, Japan

Location

1222.22.034 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1222.22.038 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1222.22.049 Boehringer Ingelheim Investigational Site

Osaka, Osaka, Japan

Location

1222.22.045 Boehringer Ingelheim Investigational Site

Osaka-sayama, Osaka, Japan

Location

1222.22.019 Boehringer Ingelheim Investigational Site

Sakai, Oasaka, Japan

Location

1222.22.006 Boehringer Ingelheim Investigational Site

Sapporo, Hokkaido, Japan

Location

1222.22.051 Boehringer Ingelheim Investigational Site

Sashima-gun, Ibaraki, Japan

Location

1222.22.031 Boehringer Ingelheim Investigational Site

Sendai, Miyagi, Japan

Location

1222.22.013 Boehringer Ingelheim Investigational Site

Seto, Aichi, Japan

Location

1222.22.024 Boehringer Ingelheim Investigational Site

Shibata-gun, Miyagi, Japan

Location

1222.22.003 Boehringer Ingelheim Investigational Site

Takarazuka, Hyogo, Japan

Location

1222.22.026 Boehringer Ingelheim Investigational Site

Tsukuba, Ibaraki, Japan

Location

1222.22.030 Boehringer Ingelheim Investigational Site

Ube, Yamaguchi, Japan

Location

1222.22.037 Boehringer Ingelheim Investigational Site

Uji, Kyoto, Japan

Location

1222.22.047 Boehringer Ingelheim Investigational Site

Wakayama, Wakayama, Japan

Location

1222.22.016 Boehringer Ingelheim Investigational Site

Yamagata, Yamagata, Japan

Location

1222.22.036 Boehringer Ingelheim Investigational Site

Yao, Osaka, Japan

Location

1222.22.011 Boehringer Ingelheim Investigational Site

Yokohama, Kanagawa, Japan

Location

Related Publications (1)

• 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.

  PMID: 26316741 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 15, 2009
• First Posted: January 16, 2009
• Study Start: January 1, 2009
• Primary Completion: March 1, 2010
• Last Updated: June 27, 2014
• Results First Posted: June 10, 2014

Record last verified: 2014-05

Locations

JP (48)