Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease I - Full Text View

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:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Formoterol fumarate Formoterol Arformoterol Tartrate

U.S. FDA Resources

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 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:

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
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:

Exclusion criteria:

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
Patients with a history of asthma and/or total blood eosinophil count greater than 600/mm3
Patients with thyrotoxicosis, paroxysmal tachycardia (>100 beats per minute)
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
Patients who have undergone thoracotomy with pulmonary resection
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.
Patients who regularly use daytime oxygen therapy for more than one hour per day.
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
Pregnant or nursing women
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

Show 93 Study Locations

Sponsors and Collaborators

Boehringer Ingelheim Pharmaceuticals

Investigators

Study Chair:

Boehringer Ingelheim

Boehringer Ingelheim Pharmaceuticals

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 May 16, 2013