BI 1744 CL With Respimat Once Daily Versus Twice Daily in COPD

NCT00846768 | Completed Phase 2 Results

• 2 other identifiers: 1222.26EudtaCT No: 2008-006334-10
• Study Type: interventional
• Target: 47
• Locations: 2 countries
• Sites: 5

Brief Summary

The primary objective of the trial is to determine the effect of BI 17444Cl on the lung function over a 24-hour period, when it is inhaled using the Respimat inhaler in patients with chronic obstructive pulmonary disease. In the trial four treatments of each 3 weeks of duration are included: 2 dosages in a once daily administration and 2 dosages for administration twice daily.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• FEV1 Area Under Curve 0-12 h (AUC 0-12h) Response After 3 Weeks of Treatment

  Response was defined as change from baseline. Baseline FEV1 AUC (0-12) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FEV1 AUC 0-12h was calculated from 0-12 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.

  Day 0: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to planned morning dose on day 1; Day 21: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to morning dose

• FEV1 Area Under Curve 12-24 h (AUC 12-24h) Response After 3 Weeks of Treatment

  Response was defined as change from baseline. Baseline FEV1 AUC (12-24) was defined as the AUC performed on the baseline visit, prior to the first dose of randomized treatment. FEV1 AUC 12-24h was calculated from 12-24 hours post-dose using the trapezoidal rule, divided by the observation time (12h) to report in litres.

  Day 0: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to planned evening dose on day 1; Day 21: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to evening dose

Secondary Outcomes (14)

• FEV1 Area Under Curve 0-24 h (AUC 0-24h) Response After 3 Weeks of Treatment

  Day0:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to planned morning dose on day1,0:30,1,2,10,11,11:50h relative to planned evening dose on day1; Day21:-0:10,0:30,1,2,3,4,6,8,10,11:50h relative to morning dose,0:30,1,2,10,11,11:50h relative to evening dose

• Peak FEV1 (0-3h) Response After 3 Weeks

  Baseline, 3 weeks

• Trough FEV1 Response

  Baseline, 3 weeks

• FVC Area Under Curve 0-12 h (AUC 0-12h) Response After 3 Weeks of Treatment

  Day 0: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to planned morning dose on day 1; Day 21: -0:10, 0:30, 1, 2, 3, 4, 6, 8, 10, 11:50 h relative to morning dose

• FVC Area Under Curve 12-24 h (AUC 12-24h) Response After 3 Weeks of Treatment

  Day 0: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to planned evening dose on day 1; Day 21: -0:10, 0:30, 1, 2, 10, 11, 11:50 h relative to evening dose

Interventions

BI 1744 CL 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 COPD and must meet the following spirometric criteria:
• Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 \< 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 must be able to perform technically acceptable pulmonary function tests
• 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 significant disease other than COPD.
• 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 will be excluded regardless of clinical condition.
• Patients with a history of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma. If a patient has a total blood eosinophil count more than 600/mm3, source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition.
• Patients with any respiratory infection or COPD exacerbation in the 6 weeks prior to the Screening Visit (Visit 1) or during the baseline period.
• Patients with any of the following conditions: a diagnosis of thyrotoxicosis; a diagnosis of paroxysmal tachycardia (\>100 beats per minute)
• Patients with any of the following conditions: a history of myocardial infarction within 1 year of screening visit (Visit 1); unstable or life-threatening cardiac arrhythmia; have been hospitalized 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 (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 being treated with any of the following concomitant medications: oral beta2-adrenergics; 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
• Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit
• Patients with known hypersensitivity to beta-adrenergics drugs, BAC, EDTA or any other component of the Respimat inhalation solution delivery system
• Pregnant or nursing women
• Women of childbearing potential not using two effective methods of birth control (one barrier, one non-barrier). 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 two years
• Patients who have previously been randomized in this study or are currently participating in another study

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (5)

1222.26.32008 Boehringer Ingelheim Investigational Site

Genk, Belgium

Location

1222.26.32006 Boehringer Ingelheim Investigational Site

Ghent, Belgium

Location

1222.26.32007 Boehringer Ingelheim Investigational Site

Hasselt, Belgium

Location

1222.26.31002 Boehringer Ingelheim Investigational Site

Eindhoven, Netherlands

Location

1222.26.31001 Boehringer Ingelheim Investigational Site

Heerlen, Netherlands

Location

Related Publications (1)

• Joos GF, Aumann JL, Coeck C, Korducki L, Hamilton AL, Kunz C, Aalbers R. A randomised, double-blind, four-way, crossover trial comparing the 24-h FEV1 profile for once-daily versus twice-daily treatment with olodaterol, a novel long-acting beta2-agonist, in patients with chronic obstructive pulmonary disease. Respir Med. 2015 May;109(5):606-15. doi: 10.1016/j.rmed.2015.02.005. Epub 2015 Feb 14.

  PMID: 25776199 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

olodaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 18, 2009
• First Posted: February 19, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2009
• Last Updated: July 1, 2014
• Results First Posted: July 1, 2014

Record last verified: 2014-05

Locations

NL (2); BE (3)