Full Text View
Tabular View
No Study Results Posted
Related Studies
Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Japanse Patients With COPD
This study is currently recruiting participants.
Verified by Boehringer Ingelheim Pharmaceuticals, April 2009
First Received: January 15, 2009   Last Updated: April 23, 2009   History of Changes
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00824382
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: BI 1744 CL inhalation sulution
Phase II

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • The primary efficacy variable will be forced expiratory volume in one second (FEV1). The primary endpoint is the trough FEV1 response [L] after 4 weeks of treatment. [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • Trough FEV1 response after 1 and 2 weeks, Trough FVC response after 1, 2 and 4 weeks, FEV1, FVC (supervised) AUC and peak response after 1,2 and 4 weeks, FEV1, FVC (unsupervised) AUC response after 4 weeks, Adverse events, pulse rate and blood pressure [ Time Frame: 4 weeks ]

Estimated Enrollment: 320
Study Start Date: January 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00824382

Contacts
Contact: Boehringer Ingelheim Study Coordinator 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Japan
1222.22.021 Boehringer Ingelheim Investigational Site Recruiting
Hitachi, Ibaraki, Japan
1222.22.022 Boehringer Ingelheim Investigational Site Recruiting
Matsumoto, Nagano, Japan
1222.22.023 Boehringer Ingelheim Investigational Site Not yet recruiting
Kawasaki, Kanagawa, Japan
1222.22.024 Boehringer Ingelheim Investigational Site Not yet recruiting
Shibata-gun, Miyagi, Japan
1222.22.025 Boehringer Ingelheim Investigational Site Recruiting
Kawasaki, Kanagawa, Japan
1222.22.026 Boehringer Ingelheim Investigational Site Recruiting
Tsukuba, Ibaraki, Japan
1222.22.027 Boehringer Ingelheim Investigational Site Recruiting
Himeji, Hyogo, Japan
1222.22.028 Boehringer Ingelheim Investigational Site Recruiting
Himeji, Hyogo, Japan
1222.22.029 Boehringer Ingelheim Investigational Site Recruiting
Kurume, Fukuoka, Japan
1222.22.030 Boehringer Ingelheim Investigational Site Recruiting
Ube, Yamaguchi, Japan
1222.22.031 Boehringer Ingelheim Investigational Site Recruiting
Sendai, Miyagi, Japan
1222.22.001 Boehringer Ingelheim Investigational Site Recruiting
Naka-gun, Ibaraki, Japan
1222.22.002 Boehringer Ingelheim Investigational Site Recruiting
Fukuoka, Fukuoka, Japan
1222.22.003 Boehringer Ingelheim Investigational Site Recruiting
Takarazuka, Hyogo, Japan
1222.22.004 Boehringer Ingelheim Investigational Site Recruiting
Kitakyusyu, Fukuoka, Japan
1222.22.005 Boehringer Ingelheim Investigational Site Recruiting
Kurume, Fukuoka, Japan
1222.22.006 Boehringer Ingelheim Investigational Site Recruiting
Sapporo, Hokkaido, Japan
1222.22.007 Boehringer Ingelheim Investigational Site Recruiting
Niigata, Niigata, Japan
1222.22.008 Boehringer Ingelheim Investigational Site Not yet recruiting
Chiba, Chiba, Japan
1222.22.009 Boehringer Ingelheim Investigational Site Recruiting
Kamogawa, Chiba, Japan
1222.22.010 Boehringer Ingelheim Investigational Site Recruiting
Inashiki-gun, Ibaraki, Japan
1222.22.011 Boehringer Ingelheim Investigational Site Recruiting
Yokohama, Kanagawa, Japan
1222.22.047 Boehringer Ingelheim Investigational Site Recruiting
Wakayama, Wakayama, Japan
1222.22.013 Boehringer Ingelheim Investigational Site Not yet recruiting
Seto, Aichi, Japan
1222.22.014 Boehringer Ingelheim Investigational Site Not yet recruiting
Komaki, Aichi, Japan
1222.22.015 Boehringer Ingelheim Investigational Site Not yet recruiting
Nagoya, Aichi, Japan
1222.22.016 Boehringer Ingelheim Investigational Site Not yet recruiting
Yamagata, Yamagata, Japan
1222.22.017 Boehringer Ingelheim Investigational Site Recruiting
Kishiwada, Osaka, Japan
1222.22.018 Boehringer Ingelheim Investigational Site Recruiting
Hiroshima, Hiroshima, Japan
1222.22.019 Boehringer Ingelheim Investigational Site Recruiting
Sakai, Oasaka, Japan
1222.22.020 Boehringer Ingelheim Investigational Site Recruiting
Koga, Fukuoka, Japan
1222.22.034 Boehringer Ingelheim Investigational Site Recruiting
Osaka, Osaka, Japan
1222.22.032 Boehringer Ingelheim Investigational Site Recruiting
Kumamoto, Kumamoto, Japan
1222.22.033 Boehringer Ingelheim Investigational Site Recruiting
Kyoto, Kyoto, Japan
1222.22.036 Boehringer Ingelheim Investigational Site Recruiting
Yao, Osaka, Japan
1222.22.037 Boehringer Ingelheim Investigational Site Recruiting
Uji, Kyoto, Japan
1222.22.038 Boehringer Ingelheim Investigational Site Recruiting
Osaka, Osaka, Japan
1222.22.040 Boehringer Ingelheim Investigational Site Recruiting
Obihiro, Hokkaido, Japan
1222.22.041 Boehringer Ingelheim Investigational Site Recruiting
Fukuoka, Fukuoka, Japan
1222.22.042 Boehringer Ingelheim Investigational Site Recruiting
Okinawa, Okinawa, Japan
1222.22.044 Boehringer Ingelheim Investigational Site Not yet recruiting
Bunkyo-ku, Tokyo, Japan
1222.22.045 Boehringer Ingelheim Investigational Site Recruiting
Osaka-sayama, Osaka, Japan
1222.22.043 Boehringer Ingelheim Investigational Site Not yet recruiting
Nagoya, Aichi, Japan
1222.22.012 Boehringer Ingelheim Investigational Site Recruiting
Itabashi-ku, Tokyo, Japan
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1222.22
Study First Received: January 15, 2009
Last Updated: April 23, 2009
ClinicalTrials.gov Identifier: NCT00824382     History of Changes
Health Authority: Japan: Ministry of Health, Labor and Welfare

Study placed in the following topic categories:
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 07, 2009