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

NCT00467740 | Completed Phase 2 Results

• 2 other identifiers: 1222.6EUDRACT 2006-004829-29
• Study Type: interventional
• Target: 296
• Locations: 4 countries
• Sites: 37

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 asthma. 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

Asthma

Outcome Measures

Primary Outcomes (1)

• Trough FEV1 Response After 4 Weeks

  Response was defined as change from baseline. Baseline trough FEV1 was defined as the mean of the -1 hour and -10 minute measurements performed just prior to first dose of randomized treatment. Trough FEV1 is defined as the FEV1 performed at -10 mins prior to study drug inhalation at the end of the dosing interval.

  Baseline and 4 weeks

Secondary Outcomes (35)

• Weekly Mean Pre-dose Morning PEFR After 4 Weeks

  Baseline and 4 weeks

• 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

Interventions

BI 1744 CL DRUG

Eligibility Criteria

• Age: 18 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
• Male or female patients, 18 years of age or older
• Diagnosis of asthma (GINA)
• Pre-bronchodilator FEV1 greater than or equal to 60% predicted and \<90% predicted (ECSC);
• Increase in FEV1 greater than or equal to 12% and 200 ml 15 minutes after 400µg salbutamol (albuterol) at Visit 1
• Patient must have been taking Inhaled Corticosteroids for at least 12 weeks prior to screening, and must have been receiving a stable low/moderate dose for at least 6 weeks prior to screening.
• Patients must be able to perform technically acceptable pulmonary function tests and PEF 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 smoking history of more than 10 pack years
• 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, a history of cor pulmonale, 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
• Patients who have undergone thoracotomy with pulmonary resection
• Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1)
• Pregnant or nursing women
• Women of childbearing potential not using a highly effective method of birth control. Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least 2 years
• Patients who have previously been randomized in this study or are currently participating in another study
• Patients who are unable to comply with pulmonary medication restrictions prior to randomization

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (37)

1222.6.064 Arthur F. Gelb Medical Corporation, Lakewood

Lakewood, California, United States

Location

1222.6.062 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1222.6.066 Allergy & Asthma Medical Group and Rsrch Ctr, APC

San Diego, California, United States

Location

1222.6.069 Allergy Associates Medical Group

San Diego, California, United States

Location

1222.6.068 National Jewish Medical Center

Denver, Colorado, United States

Location

1222.6.073 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Location

1222.6.067 Northeast Medical Research Associates, Inc

North Darthmouth, Massachusetts, United States

Location

1222.6.061 Center for Human Genomics

Winston-Salem, North Carolina, United States

Location

1222.6.072 Boehringer Ingelheim Investigational Site

Kileen, Texas, United States

Location

1222.6.071 Pulmonary Consultants

Tacoma, Washington, United States

Location

1222.6.017 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Location

1222.6.006 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

1222.6.012 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Location

1222.6.016 Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Location

1222.6.011 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Location

1222.6.003 Boehringer Ingelheim Investigational Site

Mississauga, Ontario, Canada

Location

1222.6.013 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Location

1222.6.005 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1222.6.009 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Location

1222.6.008 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1222.6.015 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Location

1222.6.007 Boehringer Ingelheim Investigational Site

Sherbrooke, Quebec, Canada

Location

1222.6.002 Boehringer Ingelheim Investigational Site

Ste-Foy, Quebec, Canada

Location

1222.6.004 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Location

1222.6.3303A Boehringer Ingelheim Investigational Site

Béthune, France

Location

1222.6.3308A Boehringer Ingelheim Investigational Site

Briançon, France

Location

1222.6.3302A Boehringer Ingelheim Investigational Site

Grenoble, France

Location

1222.6.3306A Boehringer Ingelheim Investigational Site

Lille, France

Location

1222.6.3301A Boehringer Ingelheim Investigational Site

Montpellier, France

Location

1222.6.3304A Boehringer Ingelheim Investigational Site

Nîmes, France

Location

1222.6.3305A Boehringer Ingelheim Investigational Site

Saint-Pierre Cedex - La Réunion, France

Location

1222.6.031 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1222.6.034 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

1222.6.037 Boehringer Ingelheim Investigational Site

Gauting, Germany

Location

1222.6.038 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

1222.6.032 Boehringer Ingelheim Investigational Site

Rüdersdorf, Germany

Location

1222.6.036 Boehringer Ingelheim Investigational Site

Wiesloch, Germany

Location

Related Publications (1)

• O'Byrne PM, D'Urzo T, Beck E, Flezar M, Gahlemann M, Hart L, Blahova Z, Toorawa R, Beeh KM. Dose-finding evaluation of once-daily treatment with olodaterol, a novel long-acting beta2-agonist, in patients with asthma: results of a parallel-group study and a crossover study. Respir Res. 2015 Aug 18;16(1):97. doi: 10.1186/s12931-015-0249-8.

  PMID: 26283085 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

olodaterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung 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: April 30, 2007
• First Posted: May 1, 2007
• Study Start: May 1, 2007
• Primary Completion: October 1, 2008
• Last Updated: June 27, 2014
• Results First Posted: June 11, 2014

Record last verified: 2014-06

Locations

CA (14); DE (6); US (10); FR (7)