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Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease II

NCT ID: NCT00796653

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

937 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Brief Summary

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The primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat® inhaler, in patients with 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 (BI 1744) 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

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

Formoterol 12mcg

12mcg inhaled twice daily from the Aerolizer inhaler

Group Type ACTIVE_COMPARATOR

Formoterol

Intervention Type DRUG

Active comparator with Olodaterol (BI 1744) on safety and efficacy in COPD patients

Placebo

Olodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler and/or Formoterol placebo inhaled twice daily from the Aerolizer inhaler

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo devices for comparison with Olodaterol (BI 1744) on safety and efficacy 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

Formoterol

Active comparator with Olodaterol (BI 1744) on safety and efficacy in COPD patients

Intervention Type DRUG

Placebo

Placebo devices for comparison with Olodaterol (BI 1744) on safety and efficacy in COPD patients

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:post-bronchodilator FEV1\<80% of predicted normal (ECSC) and a post-bronchodilator FEV1/FVC \<70% at Visit 1
2. Male or female patients, 40 years of age or older
3. Patients must be current or ex-smokers with a smoking history of more than 10 pack years:

Exclusion Criteria

1. 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
2. Patients with a history of asthma and/or total blood eosinophil count greater than 600/mm3
3. Patients with thyrotoxicosis, paroxysmal tachycardia (\>100 beats per minute)
4. Patients with a history of myocardial infarction within 1 year of screening visit, unstable or life-threatening cardiac arrhythmia, hospitalization 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, life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse
5. Patients who have undergone thoracotomy with pulmonary resection
6. Patients being treated with oral beta-adrenergics or 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.
7. Patients who regularly use daytime oxygen therapy for more than one hour per day.
8. 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
9. Pregnant or nursing women
10. Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).
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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1222.14.5004 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

1222.14.5003 Boehringer Ingelheim Investigational Site

Mar del Plata, , Argentina

Site Status

1222.14.5001 Boehringer Ingelheim Investigational Site

Mendoza, , Argentina

Site Status

1222.14.5002 Boehringer Ingelheim Investigational Site

Quilmes, , Argentina

Site Status

1222.14.5005 Boehringer Ingelheim Investigational Site

San Juan Bautista, , Argentina

Site Status

1222.14.5106 Boehringer Ingelheim Investigational Site

Florianópolis, , Brazil

Site Status

1222.14.5101 Boehringer Ingelheim Investigational Site

Porto Alegre, , Brazil

Site Status

1222.14.5103 Boehringer Ingelheim Investigational Site

Porto Alegre, , Brazil

Site Status

1222.14.5104 Boehringer Ingelheim Investigational Site

Porto Alegre, , Brazil

Site Status

1222.14.5102 Boehringer Ingelheim Investigational Site

Recife, , Brazil

Site Status

1222.14.5105 Boehringer Ingelheim Investigational Site

São Paulo, , Brazil

Site Status

1222.14.4005 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Site Status

1222.14.4002 Boehringer Ingelheim Investigational Site

Kelowna, British Columbia, Canada

Site Status

1222.14.4004 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1222.14.4009 Boehringer Ingelheim Investigational Site

Moncton, New Brunswick, Canada

Site Status

1222.14.4010 Boehringer Ingelheim Investigational Site

St. John's, Newfoundland and Labrador, Canada

Site Status

1222.14.4008 Boehringer Ingelheim Investigational Site

Grimsby, Ontario, Canada

Site Status

1222.14.4014 Boehringer Ingelheim Investigational Site

Mississauga, Ontario, Canada

Site Status

1222.14.4007 Boehringer Ingelheim Investigational Site

Newmarket, Ontario, Canada

Site Status

1222.14.4013 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Site Status

1222.14.4001 Boehringer Ingelheim Investigational Site

Scarborough Village, Ontario, Canada

Site Status

1222.14.4012 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

1222.14.4006 Boehringer Ingelheim Investigational Site

Québec, Quebec, Canada

Site Status

1222.14.4015 Boehringer Ingelheim Investigational Site

Sherbrooke, Quebec, Canada

Site Status

1222.14.4011 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Site Status

1222.14.6004 Boehringer Ingelheim Investigational Site

Brno, , Czechia

Site Status

1222.14.6003 Boehringer Ingelheim Investigational Site

Hradec Králové, , Czechia

Site Status

1222.14.6002 Boehringer Ingelheim Investigational Site

Kyjov, , Czechia

Site Status

1222.14.6001 Boehringer Ingelheim Investigational Site

Znojmo, , Czechia

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1222.14.4602 Boehringer Ingelheim Investigational Site

Elsinore, , Denmark

Site Status

1222.14.4601 Boehringer Ingelheim Investigational Site

Hillerød, , Denmark

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1222.14.4603 Boehringer Ingelheim Investigational Site

Roskilde, , Denmark

Site Status

1222.14.4702 Boehringer Ingelheim Investigational Site

Espoo, , Finland

Site Status

1222.14.4701 Boehringer Ingelheim Investigational Site

HUS, , Finland

Site Status

1222.14.4703 Boehringer Ingelheim Investigational Site

Lohja, , Finland

Site Status

1222.14.4106 Boehringer Ingelheim Investigational Site

Aschaffenburg, , Germany

Site Status

1222.14.4112 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1222.14.4103 Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

Site Status

1222.14.4110 Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

Site Status

1222.14.4108 Boehringer Ingelheim Investigational Site

Gelnhausen, , Germany

Site Status

1222.14.4107 Boehringer Ingelheim Investigational Site

Kelkheim, , Germany

Site Status

1222.14.4114 Boehringer Ingelheim Investigational Site

Lübeck, , Germany

Site Status

1222.14.4111 Boehringer Ingelheim Investigational Site

Mainz, , Germany

Site Status

1222.14.4113 Boehringer Ingelheim Investigational Site

Minden, , Germany

Site Status

1222.14.4109 Boehringer Ingelheim Investigational Site

Mönchengladbach, , Germany

Site Status

1222.14.4104 Boehringer Ingelheim Investigational Site

Rodgau-Dudenhofen, , Germany

Site Status

1222.14.4105 Boehringer Ingelheim Investigational Site

Wiesloch, , Germany

Site Status

1222.14.5501 Boehringer Ingelheim Investigational Site

Hong Kong, , Hong Kong

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1222.14.5412 Boehringer Ingelheim Investigational Site

Coimbatore, , India

Site Status

1222.14.5406 Boehringer Ingelheim Investigational Site

Hyderabad, , India

Site Status

1222.14.5402 Boehringer Ingelheim Investigational Site

Indore, , India

Site Status

1222.14.5405 Boehringer Ingelheim Investigational Site

Jaipur, , India

Site Status

1222.14.5409 Boehringer Ingelheim Investigational Site

Jaipur, , India

Site Status

1222.14.5403 Boehringer Ingelheim Investigational Site

Mangalore, , India

Site Status

1222.14.5407 Boehringer Ingelheim Investigational Site

Mysore, , India

Site Status

1222.14.5404 Boehringer Ingelheim Investigational Site

Nagpur, , India

Site Status

1222.14.5408 Boehringer Ingelheim Investigational Site

Noida, , India

Site Status

1222.14.5401 Boehringer Ingelheim Investigational Site

Pune, , India

Site Status

1222.14.5410 Boehringer Ingelheim Investigational Site

Vellore, , India

Site Status

1222.14.4301 Boehringer Ingelheim Investigational Site

Cassano Delle Murge (ba), , Italy

Site Status

1222.14.4302 Boehringer Ingelheim Investigational Site

Genova, , Italy

Site Status

1222.14.4304 Boehringer Ingelheim Investigational Site

Milan, , Italy

Site Status

1222.14.4305 Boehringer Ingelheim Investigational Site

Parma, , Italy

Site Status

1222.14.4303 Boehringer Ingelheim Investigational Site

Roma, , Italy

Site Status

1222.14.5701 Boehringer Ingelheim Investigational Site

Georgetown, Pulau Pinang, , Malaysia

Site Status

1222.14.5703 Boehringer Ingelheim Investigational Site

Kuala Lumpur, , Malaysia

Site Status

1222.14.5702 Boehringer Ingelheim Investigational Site

Kuching, Sarawak, , Malaysia

Site Status

1222.14.4802 Boehringer Ingelheim Investigational Site

Fredrikstad, , Norway

Site Status

1222.14.4801 Boehringer Ingelheim Investigational Site

Ski, , Norway

Site Status

1222.14.5802 Boehringer Ingelheim Investigational Site

Iloilo City, , Philippines

Site Status

1222.14.5803 Boehringer Ingelheim Investigational Site

Iloilo City, , Philippines

Site Status

1222.14.5801 Boehringer Ingelheim Investigational Site

Manila, , Philippines

Site Status

1222.14.6103 Boehringer Ingelheim Investigational Site

Brasov, , Romania

Site Status

1222.14.6102 Boehringer Ingelheim Investigational Site

Constanța, , Romania

Site Status

1222.14.6101 Boehringer Ingelheim Investigational Site

Iași, , Romania

Site Status

1222.14.6203 Boehringer Ingelheim Investigational Site

Petrozavodsk, , Russia

Site Status

1222.14.6201 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1222.14.6202 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1222.14.4901 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

Site Status

1222.14.4902 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

Site Status

1222.14.5301 Boehringer Ingelheim Investigational Site

Bucheon-si, , South Korea

Site Status

1222.14.5302 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1222.14.5305 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1222.14.5306 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1222.14.5304 Boehringer Ingelheim Investigational Site

Uijeongbu-si, , South Korea

Site Status

1222.14.5303 Boehringer Ingelheim Investigational Site

Wŏnju, , South Korea

Site Status

1222.14.4401 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1222.14.4402 Boehringer Ingelheim Investigational Site

Barcelona, , Spain

Site Status

1222.14.4406 Boehringer Ingelheim Investigational Site

Madrid, , Spain

Site Status

1222.14.4405 Boehringer Ingelheim Investigational Site

Mérida, , Spain

Site Status

1222.14.4403 Boehringer Ingelheim Investigational Site

Palma de Mallorca, , Spain

Site Status

1222.14.4407 Boehringer Ingelheim Investigational Site

Terrassa (Barcelona), , Spain

Site Status

1222.14.4501 Boehringer Ingelheim Investigational Site

Boden, , Sweden

Site Status

1222.14.4503 Boehringer Ingelheim Investigational Site

Göteboerg, , Sweden

Site Status

1222.14.4502 Boehringer Ingelheim Investigational Site

Lund, , Sweden

Site Status

1222.14.5904 Boehringer Ingelheim Investigational Site

Bangkok, , Thailand

Site Status

1222.14.5901 Boehringer Ingelheim Investigational Site

Khon Kaen, , Thailand

Site Status

1222.14.5902 Boehringer Ingelheim Investigational Site

Songkhla, , Thailand

Site Status

Countries

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Argentina Brazil Canada Czechia Denmark Finland Germany Hong Kong India Italy Malaysia Norway Philippines Romania Russia South Africa South Korea Spain Sweden Thailand

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)

Koch A, Pizzichini E, Hamilton A, Hart L, Korducki L, De Salvo MC, Paggiaro P. Lung function efficacy and symptomatic benefit of olodaterol once daily delivered via Respimat(R) versus placebo and formoterol twice daily in patients with GOLD 2-4 COPD: results from two replicate 48-week studies. Int J Chron Obstruct Pulmon Dis. 2014 Jul 5;9:697-714. doi: 10.2147/COPD.S62502. eCollection 2014.

Reference Type DERIVED
PMID: 25045258 (View on PubMed)

Other Identifiers

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2008-001934-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1222.14

Identifier Type: -

Identifier Source: org_study_id

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