Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Patients With COPD.

NCT00452400 | Completed Phase 2 Results

• 1 other identifier: 1222.5
• Study Type: interventional
• Target: 409
• Locations: 4 countries
• Sites: 42

Brief Summary

The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler for four weeks in patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy (how well it helps your breathing), safety evaluations and pharmacokinetic evaluations (the amount of the medication found in your blood).

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Outcome Measures

Primary Outcomes (1)

• Trough FEV1 Response After 4 Weeks

  Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline FEV1 is the mean of the two pre-treatment FEV1 values measured at Visit 2 (- 1 hour and - 10 minutes) prior to administration of the first dose of study medication.

  Baseline and 4 weeks

Secondary Outcomes (32)

• Trough FEV1 Response After 1 Week

  Baseline and 1 week

• Trough FEV1 Response After 2 Weeks

  Baseline and 2 weeks

• Trough FVC Response After 1 Week

  Baseline and 1 week

• Trough FVC Response After 2 Weeks

  Baseline and 2 weeks

• Trough FVC Response After 4 Weeks

  Baseline and 4 weeks

Interventions

BI 1744CL DRUG

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions
• 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 \&#61619; 30% of predicted normal and \< 80% of predicted normal 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. Patients who have never smoked cigarettes must be excluded
• Patients must be able to perform technically acceptable pulmonary function tests and PEFR measurements, and must be able to maintain records (Patient Daily e-Diary) during the study period as required in the protocol
• Patients must be able to inhale medication in a competent manner from the Respimat® inhaler and from a metered dose inhaler (MDI).

You may not qualify if:

• Patients with a history of asthma or a total blood eosinophil count 600/mm3.
• 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).
• a history of additional risk factors for Torsade de Pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT Syndrome)
• Patients with any of the following conditions:
• a history of myocardial infarction within 1 year of screening visit (Visit 1)
• a diagnosis of clinically relevant cardiac arrhythmia
• known active tuberculosis
• a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (42)

1222.5.03 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

1222.5.07 Boehringer Ingelheim Investigational Site

Lakewood, California, United States

Location

1222.5.14 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

1222.5.13 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Location

1222.5.17 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Location

1222.5.18 Boehringer Ingelheim Investigational Site

Stamford, Connecticut, United States

Location

1222.5.15 Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

Location

1222.5.04 Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, United States

Location

1222.5.22 Boehringer Ingelheim Investigational Site

Shreveport, Louisiana, United States

Location

1222.5.11 Boehringer Ingelheim Investigational Site

Reno, Nevada, United States

Location

1222.5.24 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

1222.5.12 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

Location

1222.5.10 Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

Location

1222.5.05 Boehringer Ingelheim Investigational Site

Hershey, Pennsylvania, United States

Location

1222.5.02 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1222.5.08 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

1222.5.19 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

1222.5.06 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Location

1222.5.21 Boehringer Ingelheim Investigational Site

Kileen, Texas, United States

Location

1222.5.01 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1222.5.23 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

1222.5.20 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Location

1222.5.039 St. Boniface General Hospital & Health Science Centre

Winnipeg, Manitoba, Canada

Location

1222.5.032 Division of Respirology

Halifax, Nova Scotia, Canada

Location

1222.5.038 Courtice Health Centre

Courtice, Ontario, Canada

Location

1222.5.037 Kingston General Hospital

Kingston, Ontario, Canada

Location

1222.5.031 Alpha Medical Research Inc.

Mississauga, Ontario, Canada

Location

1222.5.034 Pulmonary Care Clinic and Research Centre

Toronto, Ontario, Canada

Location

1222.5.040 Respiratory Research Lab

Toronto, Ontario, Canada

Location

1222.5.033 Centre de Recherche Clinique -CHUS

Sherbrooke, Quebec, Canada

Location

1222.5.035 Hopital Laval

Ste-Foy, Quebec, Canada

Location

1222.5.036 Department of Respiratory Medicine

Saskatoon, Saskatchewan, Canada

Location

1222.5.046 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1222.5.049 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1222.5.052 Boehringer Ingelheim Investigational Site

Gauting, Germany

Location

1222.5.051 Boehringer Ingelheim Investigational Site

Großhansdorf, Germany

Location

1222.5.047 Boehringer Ingelheim Investigational Site

Rüdersdorf, Germany

Location

1222.5.048 Boehringer Ingelheim Investigational Site

Wiesbaden, Germany

Location

1222.5.058 Boehringer Ingelheim Investigational Site

Almelo, Netherlands

Location

1222.5.056 Boehringer Ingelheim Investigational Site

Breda, Netherlands

Location

1222.5.059 Boehringer Ingelheim Investigational Site

Eindhoven, Netherlands

Location

1222.5.057 Boehringer Ingelheim Investigational Site

Heerlen, Netherlands

Location

Related Publications (1)

• Maleki-Yazdi MR, Beck E, Hamilton AL, Korducki L, Koker P, Fogarty C. A randomised, placebo-controlled, Phase II, dose-ranging trial of once-daily treatment with olodaterol, a novel long-acting beta2-agonist, for 4 weeks in patients with chronic obstructive pulmonary disease. Respir Med. 2015 May;109(5):596-605. doi: 10.1016/j.rmed.2015.02.012. Epub 2015 Mar 3.

  PMID: 25829298 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 26, 2007
• First Posted: March 27, 2007
• Study Start: March 1, 2007
• Primary Completion: January 1, 2008
• Last Updated: June 27, 2014
• Results First Posted: June 3, 2014

Record last verified: 2014-05

Locations

US (22); NL (4); DE (6); CA (10)