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12 / 48 Week Pivotal PFT vs PBO in COPD I

NCT ID: NCT00782210

Last Updated: 2014-06-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

625 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

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).

The safety of BI 1744 CL inhalation solution delivered through the Respimat inhaler will also be compared to placebo.

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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 (BI 1744) Low

Low dose inhaled orally once daily from the Respimat inhaler

Group Type EXPERIMENTAL

Olodaterol (BI1744)

Intervention Type DRUG

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

Olodaterol (BI 1744) High

High dose inhaled orally once daily from the Respimat inhaler

Group Type EXPERIMENTAL

Olodaterol (BI1744)

Intervention Type DRUG

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

Placebo

Olodaterol (BI1744) placebo inhaled orally once daily from the Respimat inhaler

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Olodaterol (BI1744) placebo inhaled orally once daily from the Respimat inhaler

Interventions

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Olodaterol (BI1744)

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

Intervention Type DRUG

Olodaterol (BI1744)

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

Intervention Type DRUG

placebo

Olodaterol (BI1744) 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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1222.11.1122 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

Site Status

1222.11.1116 Boehringer Ingelheim Investigational Site

Berkeley, California, United States

Site Status

1222.11.1121 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1222.11.1111 Boehringer Ingelheim Investigational Site

Fort Collins, Colorado, United States

Site Status

1222.11.1117 Boehringer Ingelheim Investigational Site

Stamford, Connecticut, United States

Site Status

1222.11.1110 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Site Status

1222.11.1106 Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, United States

Site Status

1222.11.1108 Boehringer Ingelheim Investigational Site

Evansville, Indiana, United States

Site Status

1222.11.1109 Boehringer Ingelheim Investigational Site

Bowling Green, Kentucky, United States

Site Status

1222.11.1113 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Site Status

1222.11.1115 Boehringer Ingelheim Investigational Site

Larchmont, New York, United States

Site Status

1222.11.1120 Boehringer Ingelheim Investigational Site

Toledo, Ohio, United States

Site Status

1222.11.1105 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Site Status

1222.11.1112 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Site Status

1222.11.1119 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Site Status

1222.11.1102 Boehringer Ingelheim Investigational Site

Union, South Carolina, United States

Site Status

1222.11.1124 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

Site Status

1222.11.1101 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

1222.11.1103 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Site Status

1222.11.1114 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Site Status

1222.11.1123 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Site Status

1222.11.1143 Boehringer Ingelheim Investigational Site

Concord, New South Wales, Australia

Site Status

1222.11.1145 Boehringer Ingelheim Investigational Site

Glebe, New South Wales, Australia

Site Status

1222.11.1144 Boehringer Ingelheim Investigational Site

Westmead, New South Wales, Australia

Site Status

1222.11.1142 Boehringer Ingelheim Investigational Site

Toorak Gardens, South Australia, Australia

Site Status

1222.11.1141 Boehringer Ingelheim Investigational Site

Woodville, South Australia, Australia

Site Status

1222.11.1166 Boehringer Ingelheim Investigational Site

Beijing, , China

Site Status

1222.11.1171 Boehringer Ingelheim Investigational Site

Changsha, , China

Site Status

1222.11.1170 Boehringer Ingelheim Investigational Site

Chengdu, , China

Site Status

1222.11.1169 Boehringer Ingelheim Investigational Site

Chongqing, , China

Site Status

1222.11.1172 Boehringer Ingelheim Investigational Site

Dalian, , China

Site Status

1222.11.1163 Boehringer Ingelheim Investigational Site

Guangzhou, , China

Site Status

1222.11.1167 Boehringer Ingelheim Investigational Site

Nanjing, , China

Site Status

1222.11.1164 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1222.11.1165 Boehringer Ingelheim Investigational Site

Shanghai, , China

Site Status

1222.11.1173 Boehringer Ingelheim Investigational Site

Shenyang, , China

Site Status

1222.11.1168 Boehringer Ingelheim Investigational Site

Xi'an, , China

Site Status

1222.11.1151 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1222.11.1156 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1222.11.1157 Boehringer Ingelheim Investigational Site

Erfurt, , Germany

Site Status

1222.11.1154 Boehringer Ingelheim Investigational Site

Halle, , Germany

Site Status

1222.11.1153 Boehringer Ingelheim Investigational Site

Kassel, , Germany

Site Status

1222.11.1158 Boehringer Ingelheim Investigational Site

Oschersleben, , Germany

Site Status

1222.11.1152 Boehringer Ingelheim Investigational Site

Potsdam, , Germany

Site Status

1222.11.1155 Boehringer Ingelheim Investigational Site

Weinheim, , Germany

Site Status

1222.11.1138 Boehringer Ingelheim Investigational Site

Hamilton, , New Zealand

Site Status

1222.11.1139 Boehringer Ingelheim Investigational Site

Otahuhu, , New Zealand

Site Status

1222.11.1136 Boehringer Ingelheim Investigational Site

Tauranga, , New Zealand

Site Status

1222.11.1137 Boehringer Ingelheim Investigational Site

Wellington, , New Zealand

Site Status

1222.11.1180 Boehringer Ingelheim Investigational Site

Changhua, , Taiwan

Site Status

1222.11.1181 Boehringer Ingelheim Investigational Site

Chiayi City, , Taiwan

Site Status

1222.11.1179 Boehringer Ingelheim Investigational Site

Taichung, , Taiwan

Site Status

1222.11.1177 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

1222.11.1178 Boehringer Ingelheim Investigational Site

Taipei, , Taiwan

Site Status

Countries

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United States Australia China Germany New Zealand 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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2008-003647-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1222.11

Identifier Type: -

Identifier Source: org_study_id

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