Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease I

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00793624
First received: November 18, 2008
Last updated: May 4, 2011
Last verified: May 2011
  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: Olodaterol (BI 1744)
Drug: Formoterol
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 48 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL (5 µg [2 Actuations of 2.5 ug] and 10 ug [2 Actuations of 5 ug]) Delivered by the Respimat® Inhaler, and 48 Weeks of Twice Daily Foradil® (12 µg) Delivered by the Aerolizer® Inhaler, in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • There are 3 co primary endpoints: FEV1 AUC 0 to 3hr response, trough FEV1 response and Mahler TDI focal score [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FEV1: pre dose and up to 3 hours post dose at selected timepoints [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • Forced Vital Capacity: pre dose and up to 3 hours post dose at selected timepoints [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • Peak Expiratory Flow Rates: pre dose morning and evening [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • Number of puffs of rescue medication used per day [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • St George's Respiratory Questionnaire at selected time points [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • Mahler Dyspnea Indices at selected timepoints [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • Patient's Global Rating at selected timepoints [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • COPD Exacerbations [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • Vital Signs: pre dose and up to 3 hours post dose at selected timepoints [ Time Frame: 48 Weeks ] [ Designated as safety issue: No ]
  • Routine blood chemistry, hematology and urinalysis at selected timepoints [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • 12 Lead ECG and Holter Monitoring (patient subset) at selected timepoints [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Enrollment: 906
Study Start Date: February 2009
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Olodaterol (BI 1744) Low
Low dose inhaled orally once daily from the Respimat inhaler
Drug: Olodaterol (BI 1744)
Comparison of low and high doses on efficacy and safety in COPD patients
Experimental: Olodaterol (BI 1744) High
High dose inhaled orally once daily from the Respimat inhaler
Drug: Olodaterol (BI 1744)
Comparison of low and high doses on efficacy and safety in COPD patients
Active Comparator: Formoterol 12mcg
12mcg inhaled twice daily from the Aerolizer inhaler
Drug: Formoterol
Active comparator with Olodaterol (BI 1744) on safety and efficacy in COPD patients
Placebo Comparator: Placebo
Olodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler and/or Formoterol placebo inhaled twice daily from the Aerolizer inhaler
Drug: Placebo
Placebo for comparison with Olodaterol (BI 1744) on safety and efficacy in COPD patients
Drug: Placebo
Placebo for comparison Formoterolon safety and efficacy in COPD patients

  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

  Hide Study Locations
Locations
Argentina
1222.13.2403 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1222.13.2401 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1222.13.2402 Boehringer Ingelheim Investigational Site
Mar del Plata, Argentina
1222.13.2404 Boehringer Ingelheim Investigational Site
Monte Grande, Argentina
Brazil
1222.13.2502 Boehringer Ingelheim Investigational Site
Juiz de Fora, Brazil
1222.13.2503 Boehringer Ingelheim Investigational Site
Rio de Janeiro, Brazil
1222.13.2505 Boehringer Ingelheim Investigational Site
Rio de Janeiro, Brazil
1222.13.2504 Boehringer Ingelheim Investigational Site
Sao Paulo, Brazil
1222.13.2501 Boehringer Ingelheim Investigational Site
Sao Paulo, Brazil
Canada, Alberta
1222.13.1408 Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
Canada, British Columbia
1222.13.1407 Boehringer Ingelheim Investigational Site
Chilliwack, British Columbia, Canada
Canada, Ontario
1222.13.1403 Boehringer Ingelheim Investigational Site
Downsview, Ontario, Canada
1222.13.1412 Boehringer Ingelheim Investigational Site
Hamilton, Ontario, Canada
1222.13.1401 Boehringer Ingelheim Investigational Site
Niagara Falls, Ontario, Canada
1222.13.1410 Boehringer Ingelheim Investigational Site
Sarnia, Ontario, Canada
1222.13.1413 Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Canada, Quebec
1222.13.1404 Boehringer Ingelheim Investigational Site
La Malbaie, Quebec, Canada
1222.13.1411 Boehringer Ingelheim Investigational Site
Montreal, Quebec, Canada
1222.13.1406 Boehringer Ingelheim Investigational Site
Point Claire, Quebec, Canada
Canada, Saskatchewan
1222.13.1402 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada
Croatia
1222.13.3502 Boehringer Ingelheim Investigational Site
Dubrovnik, Croatia
1222.13.3503 Boehringer Ingelheim Investigational Site
Rijeka, Croatia
1222.13.3504 Boehringer Ingelheim Investigational Site
Split, Croatia
1222.13.3501 Boehringer Ingelheim Investigational Site
Zagreb, Croatia
Czech Republic
1222.13.3401 Boehringer Ingelheim Investigational Site
Beroun, Czech Republic
1222.13.3403 Boehringer Ingelheim Investigational Site
Cesky Tesin, Czech Republic
1222.13.3402 Boehringer Ingelheim Investigational Site
Tabor, Czech Republic
Denmark
1222.13.2003 Boehringer Ingelheim Investigational Site
Aalborg, Denmark
1222.13.2002 Boehringer Ingelheim Investigational Site
Hvidovre, Denmark
1222.13.2001 Boehringer Ingelheim Investigational Site
Silkeborg, Denmark
Finland
1222.13.2103 Boehringer Ingelheim Investigational Site
Lahti, Finland
1222.13.2101 Boehringer Ingelheim Investigational Site
Tampere, Finland
1222.13.2102 Boehringer Ingelheim Investigational Site
Turku, Finland
Germany
1222.13.1503 Boehringer Ingelheim Investigational Site
Berlin, Germany
1222.13.1502 Boehringer Ingelheim Investigational Site
Berlin, Germany
1222.13.1506 Boehringer Ingelheim Investigational Site
Berlin, Germany
1222.13.1511 Boehringer Ingelheim Investigational Site
Dortmund, Germany
1222.13.1514 Boehringer Ingelheim Investigational Site
Essen, Germany
1222.13.1509 Boehringer Ingelheim Investigational Site
Großhansdorf, Germany
1222.13.1508 Boehringer Ingelheim Investigational Site
Hannover, Germany
1222.13.1510 Boehringer Ingelheim Investigational Site
Hannover, Germany
1222.13.1512 Boehringer Ingelheim Investigational Site
Kiel, Germany
1222.13.1501 Boehringer Ingelheim Investigational Site
Köln, Germany
1222.13.1505 Boehringer Ingelheim Investigational Site
Reinfeld, Germany
1222.13.1507 Boehringer Ingelheim Investigational Site
Schwerin, Germany
Hong Kong
1222.13.2901 Boehringer Ingelheim Investigational Site
Kowloon, Hong Kong
India
1222.13.2804 Boehringer Ingelheim Investigational Site
Bangalore, India
1222.13.2803 Boehringer Ingelheim Investigational Site
Chennai, India
1222.13.2806 Boehringer Ingelheim Investigational Site
Coimbatore-, India
1222.13.2810 Boehringer Ingelheim Investigational Site
Hyderabad, India
1222.13.2801 Boehringer Ingelheim Investigational Site
Indore, India
1222.13.2807 Boehringer Ingelheim Investigational Site
Indore, India
1222.13.2805 Boehringer Ingelheim Investigational Site
Jaipur, India
1222.13.2802 Boehringer Ingelheim Investigational Site
Ludhiana, Punjab, India
1222.13.2809 Boehringer Ingelheim Investigational Site
Mumbai, India
1222.13.2812 Boehringer Ingelheim Investigational Site
Mumbai, India
1222.13.2811 Boehringer Ingelheim Investigational Site
Pune, India
Italy
1222.13.1704 Boehringer Ingelheim Investigational Site
Catania, Italy
1222.13.1702 Boehringer Ingelheim Investigational Site
Genova, Italy
1222.13.1701 Boehringer Ingelheim Investigational Site
Pisa, Italy
1222.13.1705 Boehringer Ingelheim Investigational Site
Siena, Italy
1222.13.1703 Boehringer Ingelheim Investigational Site
Trieste, Italy
Korea, Republic of
1222.13.2701 Boehringer Ingelheim Investigational Site
Gwangju, Korea, Republic of
1222.13.2702 Boehringer Ingelheim Investigational Site
Incheon, Korea, Republic of
1222.13.2706 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1222.13.2705 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1222.13.2703 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1222.13.2704 Boehringer Ingelheim Investigational Site
Suwon, Korea, Republic of
Malaysia
1222.13.3103 Boehringer Ingelheim Investigational Site
Batu Caves, Malaysia
1222.13.3101 Boehringer Ingelheim Investigational Site
Kota Kinabalu, Malaysia
1222.13.3102 Boehringer Ingelheim Investigational Site
Kuala Lumpur, Malaysia
1222.13.3104 Boehringer Ingelheim Investigational Site
Kuantan, Malaysia
Norway
1222.13.2201 Boehringer Ingelheim Investigational Site
Bergen, Norway
1222.13.2202 Boehringer Ingelheim Investigational Site
Oslo, Norway
Philippines
1222.13.3203 Boehringer Ingelheim Investigational Site
Cebu, Philippines
1222.13.3202 Boehringer Ingelheim Investigational Site
Quezon City, Philippines
1222.13.3201 Boehringer Ingelheim Investigational Site
Quezon City, Philippines
South Africa
1222.13.2302 Boehringer Ingelheim Investigational Site
Durban, South Africa
1222.13.2301 Boehringer Ingelheim Investigational Site
Pretoria, South Africa
Spain
1222.13.1803 Boehringer Ingelheim Investigational Site
Aranjuez, Spain
1222.13.1806 Boehringer Ingelheim Investigational Site
Elda, Spain
1222.13.1802 Boehringer Ingelheim Investigational Site
Els Hostalets de Balenyà, Spain
1222.13.1804 Boehringer Ingelheim Investigational Site
Pozuelo de Alarcón, Spain
1222.13.1805 Boehringer Ingelheim Investigational Site
Valladolid, Spain
1222.13.1801 Boehringer Ingelheim Investigational Site
Vic (Barcelona), Spain
Sweden
1222.13.1901 Boehringer Ingelheim Investigational Site
Boden, Sweden
1222.13.1902 Boehringer Ingelheim Investigational Site
Sundsvall, Sweden
Thailand
1222.13.3303 Boehringer Ingelheim Investigational Site
Bangkok, Thailand
1222.13.3302 Boehringer Ingelheim Investigational Site
Bangkok, Thailand
1222.13.3301 Boehringer Ingelheim Investigational Site
Chiang Mai, Thailand
Ukraine
1222.13.3602 Boehringer Ingelheim Investigational Site
Ivano-Frankivsk, Ukraine
1222.13.3601 Boehringer Ingelheim Investigational Site
Kharkiv, Ukraine
1222.13.3603 Boehringer Ingelheim Investigational Site
Kiev, Ukraine
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00793624     History of Changes
Other Study ID Numbers: 1222.13, 2008-001933-84
Study First Received: November 18, 2008
Last Updated: May 4, 2011
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: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
India: Drugs Controller General of India
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)

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Formoterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014