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Safety and Efficacy of BI 1744 CL in Patients With COPD I
This study is not yet open for participant recruitment.
Verified by Boehringer Ingelheim Pharmaceuticals, December 2008
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00793624
  Purpose

The primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat® inhaler, in patients with COPD.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: BI 1744 CL
Drug: Formoterol
Phase III

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for: Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Parallel Assignment, Safety/Efficacy Study
Official Title: A Randomised, Double-Blind, Double Dummy, Placebo-Controlled, Parallel-Group Efficacy and Safety Comparison of One-Year Treatment of Two Doses (5mcg (2 Actuations of 2.5 Mcg) and 10mcg (2 Actuations of 5mcg)) of BI 1744 CL Inhalation Solution Delivered by the Respimat® Inhaler, and One Dose (12mcg) of Foradil® Delivered by the Aerolizer® Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD).

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • There are 3 co primary endpoints: FEV1 AUC 0 to 3hr response, trough FEV1 response and the Mahler TDI (focal score: combined with 1222.14 trial) [ Time Frame: 24 Weeks ]

Secondary Outcome Measures:
  • FEV1 AUC response after 2, 6, 12 and 48 weeks FEV1 trough after 2, 6, 12, 18, 24, 32, 40 and 48 weeks FEV1 peak SGRQ after 12 and 48 weeks [ Time Frame: 48 Weeks ]

Estimated Enrollment: 860
Study Start Date: November 2008
Estimated Primary Completion Date: October 2010 (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 have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:post-bronchodilator FEV1<80% of predicted normal (ECSC) and a post-bronchodilator FEV1/FVC <70% at Visit 1
  2. Male or female patients, 40 years of age or older
  3. Patients must be current or ex-smokers with a smoking history of more than 10 pack years.

Exclusion Criteria:

  1. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT >x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN
  2. Patients with a history of asthma and/or total blood eosinophil count greater than 600/mm3
  3. Patients with thyrotoxicosis, paroxysmal tachycardia (>100 beats per minute)
  4. Patients with a history of myocardial infarction within 1 year of screening visit, unstable or life-threatening cardiac arrhythmia, hospitalization for heart failure within the past year, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse
  5. Patients who have undergone thoracotomy with pulmonary resection
  6. Patients being treated with oral beta-adrenergics or 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.
  7. Patients who regularly use daytime oxygen therapy for more than one hour per day.
  8. 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
  9. Pregnant or nursing women
  10. Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00793624

Contacts
Contact: Boehringer Ingelheim Study Coordinator 800-542-6257 ext Option 4 clintriage.rdg@boehringer-ingelheim.com

Locations
Canada, Alberta
1222.13.1408 Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
1222.13.1409 Boehringer Ingelheim Investigational Site
Edmonton, Alberta, Canada
Canada, British Columbia
1222.13.1407 Boehringer Ingelheim Investigational Site
Chilliwack, British Columbia, Canada
Canada, Ontario
1222.13.1413 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
1222.13.1401 Boehringer Ingelheim Investigational Site
Niagara Falls, Ontario, Canada
1222.13.1403 Boehringer Ingelheim Investigational Site
Downsview, Ontario, Canada
1222.13.1410 Boehringer Ingelheim Investigational Site
Sarnia, Ontario, Canada
1222.13.1412 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
Canada, Quebec
1222.13.1404 Boehringer Ingelheim Investigational Site
La Malbaie, Quebec, Canada
1222.13.1406 Boehringer Ingelheim Investigational Site
Point Claire, Quebec, Canada
1222.13.1411 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
Canada, Saskatchewan
1222.13.1402 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada
Denmark
1222.13.2001 Boehringer Ingelheim Investigational Site
Silkeborg, Denmark
1222.13.2002 Boehringer Ingelheim Investigational Site
Hvidovre, Denmark
1222.13.2003 Boehringer Ingelheim Investigational Site
Aalborg, Denmark
Finland
1222.13.2101 Boehringer Ingelheim Investigational Site
Tampere, Finland
1222.13.2102 Boehringer Ingelheim Investigational Site
Turku, Finland
1222.13.2103 Boehringer Ingelheim Investigational Site
Lahti, Finland
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1222.13, Eudract: 2008-001933-84
Study First Received: November 18, 2008
Last Updated: December 12, 2008
ClinicalTrials.gov Identifier: NCT00793624  
Health Authority: Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica);   Brazil: National Health Surveillance Agency;   Canada: Therapeutic Products Directorate;   Croatia: Croatian Institute for Medicines Control, HR-10000 Zagreb;   Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10;   Denmark: The Danish Medicines Agency;   Finland: National Agency for Medicines;   Germany: Federal Institute for Drugs and Medical Devices;   Hong Kong: Department of Health;   India: Ministry of Health and Family Welfare;   Italy: Comitato Etico per la sperim. clinica dei medicinali dell'A.O. Universitaria Pisana di Pisa;   Korea, Republic of: Korea Food and Drug Administration;   Malaysia: Ministry of Health;   Norway: Norwegian Medicines Agency (Statens Legemiddelverk);   Philippines: Department of Health;   South Africa: Medicines Control Council;   Spain: Agencia Espanola del Medicamento y Productos Sanitarios;   Sweden: Medical Products Agency Regional Ethics Committee of Umeå;   Thailand: Ministry of Public Health;   Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine)

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

Additional relevant MeSH terms:
Respiratory System Agents
Disease Attributes
Neurotransmitter Agents
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Adrenergic Agonists
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 15, 2009