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12 / 48 wk Pivotal PFT vs PBO in COPD II

NCT ID: NCT00782509

Last Updated: 2014-06-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

644 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Brief Summary

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This primary objective of this study is to compare two doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary disease (COPD).

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Olodaterol (BI1744) Low

Low dose inhaled orally once daily from the Respimat inhaler

Group Type EXPERIMENTAL

Olodaterol (BI 1744)

Intervention Type DRUG

Comparison of low and high doses on efficacy and safety in COPD patients

Placebo

Olodaterol (BI 1744) placebo inhaled orally once daily from the Respimat inhaler

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Olodaterol (BI 1744) placebo inhaled orally once daily from the Respimat inhaler

Olodaterol (BI 1744) High

High dose inhaled orally once daily from the Respimat inhaler

Group Type EXPERIMENTAL

Olodaterol (BI 1744)

Intervention Type DRUG

Comparison of low and high doses on efficacy and safety in COPD patients

Interventions

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Olodaterol (BI 1744)

Comparison of low and high doses on efficacy and safety in COPD patients

Intervention Type DRUG

Olodaterol (BI 1744)

Comparison of low and high doses on efficacy and safety in COPD patients

Intervention Type DRUG

Placebo

Olodaterol (BI 1744) placebo inhaled orally once daily from the Respimat inhaler

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All patients must have a diagnosis of chronic obstructive pulmonary disease
* 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 Post bronchodilator FEV1 \<80% predicted and post-bronchodilator FEV1/FVC \<70%

Exclusion Criteria

* Patients with a significant disease other than COPD
* Patients with a history of asthma
* 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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1222.12.1227 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Site Status

1222.12.1218 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Site Status

1222.12.1226 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Site Status

1222.12.1214 Boehringer Ingelheim Investigational Site

Waterbury, Connecticut, United States

Site Status

1222.12.1207 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Site Status

1222.12.1224 Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

Site Status

1222.12.1222 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Site Status

1222.12.1208 Boehringer Ingelheim Investigational Site

Winter Park, Florida, United States

Site Status

1222.12.1220 Boehringer Ingelheim Investigational Site

River Forest, Illinois, United States

Site Status

1222.12.1229 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

Site Status

1222.12.1219 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

Site Status

1222.12.1209 Boehringer Ingelheim Investigational Site

Livonia, Michigan, United States

Site Status

1222.12.1233 Boehringer Ingelheim Investigational Site

Henderson, Nevada, United States

Site Status

1222.12.1228 Boehringer Ingelheim Investigational Site

Summit, New Jersey, United States

Site Status

1222.12.1206 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Site Status

1222.12.1205 Boehringer Ingelheim Investigational Site

Rochester, New York, United States

Site Status

1222.12.1213 Boehringer Ingelheim Investigational Site

Elizabeth City, North Carolina, United States

Site Status

1222.12.1223 Boehringer Ingelheim Investigational Site

Harrisburg, North Carolina, United States

Site Status

1222.12.1217 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

Site Status

1222.12.1203 Boehringer Ingelheim Investigational Site

Cincinnatti, Ohio, United States

Site Status

1222.12.1201 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

1222.12.1230 Boehringer Ingelheim Investigational Site

Easley, South Carolina, United States

Site Status

1222.12.1216 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Site Status

1222.12.1221 Boehringer Ingelheim Investigational Site

Dallas, Texas, United States

Site Status

1222.12.1212 Boehringer Ingelheim Investigational Site

Danville, Virginia, United States

Site Status

1222.12.1211 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

1222.12.1225 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

1222.12.1232 Boehringer Ingelheim Investigational Site

Morgantown, West Virginia, United States

Site Status

1222.12.1298 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1222.12.1301 Boehringer Ingelheim Investigational Site

Chongqing, , China

Site Status

1222.12.1305 Boehringer Ingelheim Investigational Site

Guangzhou, , China

Site Status

1222.12.1306 Boehringer Ingelheim Investigational Site

Haikou, , China

Site Status

1222.12.1302 Boehringer Ingelheim Investigational Site

Hangzhou, , China

Site Status

1222.12.1304 Boehringer Ingelheim Investigational Site

Nanjing, , China

Site Status

1222.12.1296 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1222.12.1297 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1222.12.1303 Boehringer Ingelheim Investigational Site

Wuhan, , China

Site Status

1222.12.1299 Boehringer Ingelheim Investigational Site

Xi'an, , China

Site Status

1222.12.1300 Boehringer Ingelheim Investigational Site

Xi'an, , China

Site Status

1222.12.1269 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1222.12.1270 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1222.12.1271 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1222.12.1268 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1222.12.1266 Boehringer Ingelheim Investigational Site

Koblenz, , Germany

Site Status

1222.12.1272 Boehringer Ingelheim Investigational Site

Mannheim, , Germany

Site Status

1222.12.1267 Boehringer Ingelheim Investigational Site

Rüdersdorf, , Germany

Site Status

1222.12.1290 Boehringer Ingelheim Investigational Site

Kaohsiung City, , Taiwan

Site Status

1222.12.1289 Boehringer Ingelheim Investigational Site

Kaohsiung County, , Taiwan

Site Status

1222.12.1288 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

Site Status

1222.12.1287 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1222.12.1286 Boehringer Ingelheim Investigational Site

Taoyuan District, , Taiwan

Site Status

Countries

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United States China Germany Taiwan

References

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Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.

Reference Type DERIVED
PMID: 32943047 (View on PubMed)

Andreas S, Bothner U, de la Hoz A, Kloer I, Trampisch M, Alter P. A Post Hoc Holter ECG Analysis of Olodaterol and Formoterol in Moderate-to-Very-Severe COPD. Int J Chron Obstruct Pulmon Dis. 2020 Aug 10;15:1955-1965. doi: 10.2147/COPD.S246353. eCollection 2020.

Reference Type DERIVED
PMID: 32848381 (View on PubMed)

Andreas S, Bothner U, Trampisch M, Haensel M, Buhl R, Alter P. Effect of long-acting beta2-agonists olodaterol and formoterol on heart rate and blood pressure in chronic obstructive pulmonary disease patients. Pulm Pharmacol Ther. 2018 Oct;52:1-6. doi: 10.1016/j.pupt.2018.08.002. Epub 2018 Aug 2.

Reference Type DERIVED
PMID: 30077810 (View on PubMed)

Ferguson GT, Feldman GJ, Hofbauer P, Hamilton A, Allen L, Korducki L, Sachs P. Efficacy and safety of olodaterol once daily delivered via Respimat(R) in patients with GOLD 2-4 COPD: results from two replicate 48-week studies. Int J Chron Obstruct Pulmon Dis. 2014 Jun 16;9:629-45. doi: 10.2147/COPD.S61717. eCollection 2014.

Reference Type DERIVED
PMID: 24966672 (View on PubMed)

Other Identifiers

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2008-003704-67

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1222.12

Identifier Type: -

Identifier Source: org_study_id

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