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

November 18, 2008
May 4, 2011
February 2009
December 2010   (final data collection date for primary outcome measure)
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 ]
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 ]
Complete list of historical versions of study NCT00793624 on ClinicalTrials.gov Archive Site
  • 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 ]
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 ]
Not Provided
Not Provided
 
Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease I
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: Olodaterol (BI 1744)
    Comparison of low and high doses on efficacy and safety in COPD patients
  • Drug: Formoterol
    Active comparator with Olodaterol (BI 1744) on safety and efficacy in COPD patients
  • 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
  • Experimental: Olodaterol (BI 1744) Low
    Low dose inhaled orally once daily from the Respimat inhaler
    Intervention: Drug: Olodaterol (BI 1744)
  • Experimental: Olodaterol (BI 1744) High
    High dose inhaled orally once daily from the Respimat inhaler
    Intervention: Drug: Olodaterol (BI 1744)
  • Active Comparator: Formoterol 12mcg
    12mcg inhaled twice daily from the Aerolizer inhaler
    Intervention: Drug: Formoterol
  • 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
    Interventions:
    • Drug: Placebo
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
906
Not Provided
December 2010   (final data collection date for primary outcome measure)

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).
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Brazil,   Canada,   Croatia,   Czech Republic,   Denmark,   Finland,   Germany,   Hong Kong,   India,   Italy,   Korea, Republic of,   Malaysia,   Norway,   Philippines,   South Africa,   Spain,   Sweden,   Thailand,   Ukraine
 
NCT00793624
1222.13, 2008-001933-84
Not Provided
Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP