MedDataX Logo

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

NCT ID: NCT00793624

Last Updated: 2014-06-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

906 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00796653

Pulmonary Disease, Chronic Obstructive
COMPLETED PHASE3

12 / 48 Week Pivotal PFT vs PBO in COPD I

NCT00782210

Pulmonary Disease, Chronic Obstructive
COMPLETED PHASE3

12 / 48 wk Pivotal PFT vs PBO in COPD II

NCT00782509

Pulmonary Disease, Chronic Obstructive
COMPLETED PHASE3

A Study of the Safety and Efficacy of 4 Doses of BI 1744 CL Delivered Via the Respimat in Patients With Asthma.

NCT01013753

Asthma
COMPLETED PHASE2

Characterisation of 24-hour FEV1-time Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease

NCT00932646

Pulmonary Disease, Chronic Obstructive
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Placebo

Intervention Type DRUG

Placebo for comparison Formoterolon safety and efficacy in COPD patients

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Placebo

Placebo for comparison Formoterolon safety and efficacy in COPD patients

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Meet the organizations funding or collaborating on the study and learn about their roles.

Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Boehringer Ingelheim

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

1222.13.2401 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

1222.13.2403 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

Site Status

1222.13.2402 Boehringer Ingelheim Investigational Site

Mar del Plata, , Argentina

Site Status

1222.13.2404 Boehringer Ingelheim Investigational Site

Monte Grande, , Argentina

Site Status

1222.13.2502 Boehringer Ingelheim Investigational Site

Juiz de Fora, , Brazil

Site Status

1222.13.2503 Boehringer Ingelheim Investigational Site

Rio de Janeiro, , Brazil

Site Status

1222.13.2505 Boehringer Ingelheim Investigational Site

Rio de Janeiro, , Brazil

Site Status

1222.13.2501 Boehringer Ingelheim Investigational Site

São Paulo, , Brazil

Site Status

1222.13.2504 Boehringer Ingelheim Investigational Site

São Paulo, , Brazil

Site Status

1222.13.1408 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Site Status

1222.13.1407 Boehringer Ingelheim Investigational Site

Chilliwack, British Columbia, Canada

Site Status

1222.13.1403 Boehringer Ingelheim Investigational Site

Downsview, Ontario, Canada

Site Status

1222.13.1412 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

1222.13.1401 Boehringer Ingelheim Investigational Site

Niagara Falls, Ontario, Canada

Site Status

1222.13.1410 Boehringer Ingelheim Investigational Site

Sarnia, Ontario, Canada

Site Status

1222.13.1413 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1222.13.1404 Boehringer Ingelheim Investigational Site

La Malbaie, Quebec, Canada

Site Status

1222.13.1411 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

1222.13.1406 Boehringer Ingelheim Investigational Site

Point Claire, Quebec, Canada

Site Status

1222.13.1402 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Site Status

1222.13.3502 Boehringer Ingelheim Investigational Site

Dubrovnik, , Croatia

Site Status

1222.13.3503 Boehringer Ingelheim Investigational Site

Rijeka, , Croatia

Site Status

1222.13.3504 Boehringer Ingelheim Investigational Site

Split, , Croatia

Site Status

1222.13.3501 Boehringer Ingelheim Investigational Site

Zagreb, , Croatia

Site Status

1222.13.3401 Boehringer Ingelheim Investigational Site

Beroun, , Czechia

Site Status

1222.13.3403 Boehringer Ingelheim Investigational Site

Český Těšín, , Czechia

Site Status

1222.13.3402 Boehringer Ingelheim Investigational Site

Tábor, , Czechia

Site Status

1222.13.2003 Boehringer Ingelheim Investigational Site

Aalborg, , Denmark

Site Status

1222.13.2002 Boehringer Ingelheim Investigational Site

Hvidovre, , Denmark

Site Status

1222.13.2001 Boehringer Ingelheim Investigational Site

Silkeborg, , Denmark

Site Status

1222.13.2103 Boehringer Ingelheim Investigational Site

Lahti, , Finland

Site Status

1222.13.2101 Boehringer Ingelheim Investigational Site

Tampere, , Finland

Site Status

1222.13.2102 Boehringer Ingelheim Investigational Site

Turku, , Finland

Site Status

1222.13.1502 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1222.13.1503 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1222.13.1506 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1222.13.1501 Boehringer Ingelheim Investigational Site

Cologne, , Germany

Site Status

1222.13.1511 Boehringer Ingelheim Investigational Site

Dortmund, , Germany

Site Status

1222.13.1514 Boehringer Ingelheim Investigational Site

Essen, , Germany

Site Status

1222.13.1509 Boehringer Ingelheim Investigational Site

Großhansdorf, , Germany

Site Status

1222.13.1508 Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

1222.13.1510 Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

1222.13.1512 Boehringer Ingelheim Investigational Site

Kiel, , Germany

Site Status

1222.13.1505 Boehringer Ingelheim Investigational Site

Reinfeld, , Germany

Site Status

1222.13.1507 Boehringer Ingelheim Investigational Site

Schwerin, , Germany

Site Status

1222.13.2901 Boehringer Ingelheim Investigational Site

Kowloon, , Hong Kong

Site Status

1222.13.2804 Boehringer Ingelheim Investigational Site

Bangalore, , India

Site Status

1222.13.2803 Boehringer Ingelheim Investigational Site

Chennai, , India

Site Status

1222.13.2806 Boehringer Ingelheim Investigational Site

Coimbatore, , India

Site Status

1222.13.2810 Boehringer Ingelheim Investigational Site

Hyderabad, , India

Site Status

1222.13.2801 Boehringer Ingelheim Investigational Site

Indore, , India

Site Status

1222.13.2807 Boehringer Ingelheim Investigational Site

Indore, , India

Site Status

1222.13.2805 Boehringer Ingelheim Investigational Site

Jaipur, , India

Site Status

1222.13.2802 Boehringer Ingelheim Investigational Site

Ludhiana, Punjab, , India

Site Status

1222.13.2809 Boehringer Ingelheim Investigational Site

Mumbai, , India

Site Status

1222.13.2812 Boehringer Ingelheim Investigational Site

Mumbai, , India

Site Status

1222.13.2811 Boehringer Ingelheim Investigational Site

Pune, , India

Site Status

1222.13.1704 Boehringer Ingelheim Investigational Site

Catania, , Italy

Site Status

1222.13.1702 Boehringer Ingelheim Investigational Site

Genova, , Italy

Site Status

1222.13.1701 Boehringer Ingelheim Investigational Site

Pisa, , Italy

Site Status

1222.13.1705 Boehringer Ingelheim Investigational Site

Siena, , Italy

Site Status

1222.13.1703 Boehringer Ingelheim Investigational Site

Trieste, , Italy

Site Status

1222.13.3103 Boehringer Ingelheim Investigational Site

Batu Caves, , Malaysia

Site Status

1222.13.3101 Boehringer Ingelheim Investigational Site

Kota Kinabalu, , Malaysia

Site Status

1222.13.3102 Boehringer Ingelheim Investigational Site

Kuala Lumpur, , Malaysia

Site Status

1222.13.3104 Boehringer Ingelheim Investigational Site

Kuantan, , Malaysia

Site Status

1222.13.2201 Boehringer Ingelheim Investigational Site

Bergen, , Norway

Site Status

1222.13.2202 Boehringer Ingelheim Investigational Site

Oslo, , Norway

Site Status

1222.13.3203 Boehringer Ingelheim Investigational Site

Cebu, , Philippines

Site Status

1222.13.3201 Boehringer Ingelheim Investigational Site

Quezon City, , Philippines

Site Status

1222.13.3202 Boehringer Ingelheim Investigational Site

Quezon City, , Philippines

Site Status

1222.13.2302 Boehringer Ingelheim Investigational Site

Durban, , South Africa

Site Status

1222.13.2301 Boehringer Ingelheim Investigational Site

Pretoria, , South Africa

Site Status

1222.13.2701 Boehringer Ingelheim Investigational Site

Gwangju, , South Korea

Site Status

1222.13.2702 Boehringer Ingelheim Investigational Site

Incheon, , South Korea

Site Status

1222.13.2703 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1222.13.2705 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1222.13.2706 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1222.13.2704 Boehringer Ingelheim Investigational Site

Suwon, , South Korea

Site Status

1222.13.1803 Boehringer Ingelheim Investigational Site

Aranjuez, , Spain

Site Status

1222.13.1806 Boehringer Ingelheim Investigational Site

Elda, , Spain

Site Status

1222.13.1802 Boehringer Ingelheim Investigational Site

els Hostalets de Balenyà, , Spain

Site Status

1222.13.1804 Boehringer Ingelheim Investigational Site

Pozuelo de Alarcón, , Spain

Site Status

1222.13.1805 Boehringer Ingelheim Investigational Site

Valladolid, , Spain

Site Status

1222.13.1801 Boehringer Ingelheim Investigational Site

Vic (Barcelona), , Spain

Site Status

1222.13.1901 Boehringer Ingelheim Investigational Site

Boden, , Sweden

Site Status

1222.13.1902 Boehringer Ingelheim Investigational Site

Sundsvall, , Sweden

Site Status

1222.13.3302 Boehringer Ingelheim Investigational Site

Bangkok, , Thailand

Site Status

1222.13.3303 Boehringer Ingelheim Investigational Site

Bangkok, , Thailand

Site Status

1222.13.3301 Boehringer Ingelheim Investigational Site

Chiang Mai, , Thailand

Site Status

1222.13.3602 Boehringer Ingelheim Investigational Site

Ivano-Frankivsk, , Ukraine

Site Status

1222.13.3601 Boehringer Ingelheim Investigational Site

Kharkiv, , Ukraine

Site Status

1222.13.3603 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

Site Status

Countries

Review the countries where the study has at least one active or historical site.

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

References

Explore related publications, articles, or registry entries linked to this study.

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

Review additional registry numbers or institutional identifiers associated with this trial.

2008-001933-84

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1222.13

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Patients With COPD.
NCT00452400 COMPLETED PHASE2
BI 1744 CL With Respimat Once Daily Versus Twice Daily in COPD
NCT00846768 COMPLETED PHASE2
Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry II
NCT01040793 COMPLETED PHASE3
Single Dose Ranging Study of BI 1744 CL (Olodaterol) in Chronic Obstructive Pulmonary Disease
NCT01809262 COMPLETED PHASE2
Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Foradil in Patients With Chronic Obstructive Pulmonary Disease
NCT00931385 COMPLETED PHASE3
Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry I
NCT01040130 COMPLETED PHASE3
Efficacy and Safety of 4 Weeks of Treatment With Orally Inhaled BI1744/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT00720499 COMPLETED PHASE2
Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease
NCT01040689 COMPLETED PHASE3
Determining Optimal Free Dose Combination of Tiotropium Bromide and BI 1744 CL in Chronic Obstructive Pulmonary Disease (COPD)
NCT01040403 COMPLETED PHASE2
A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease
NCT01040728 COMPLETED PHASE3
Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Japanese Patients With COPD
NCT00824382 COMPLETED PHASE2
Combination of Orally Inhaled BI1744CL/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease ( COPD)
NCT00696020 COMPLETED PHASE2
Pharmacokinetics and Safety of BI 1744 CL Plus Tiotropium Bromide in Chronic Obstructive Pulmonary Disease (COPD)
NCT02231177 COMPLETED PHASE1
A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD
NCT04320342 COMPLETED PHASE3
Efficacy and Safety Study of Two Fixed-dose Combinations of Aclidinium Bromide With Formoterol Fumarate Compared With Aclidinium Bromide, Formoterol Fumarate and Placebo
NCT01049360 COMPLETED PHASE2
Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD
NCT00476099 COMPLETED PHASE3
Changes in Cardiac Function in COPD Patients After Administration of Budesonide/Formoterol (Symbicort®) Versus Placebo
NCT01760304 TERMINATED PHASE4
Efficacy and Safety of Two Doses of Formoterol Fumarate MDI (PT005) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), Compared to Foradil® Aerolizer® as an Active Control
NCT01043601 WITHDRAWN PHASE2
Comparison of Safety and Efficacy of Berodual® Administered Via the Respimat® Device With That Administered Via the Metered Dose Inhaler (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT02173782 COMPLETED PHASE3
Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) Taking Salmeterol Xinafoate/Fluticasone Propionate Combination
NCT01321463 COMPLETED PHASE2
Characterization of 24-hour Lung Function Profiles of Inhaled Tiotropium + Olodaterol Fixed Dose Combination in Patients Suffering From Chronic Obstructive Pulmonary Disease
NCT01559116 COMPLETED PHASE3
Safety and Tolerability of Aclidinium Bromide/Formoterol Fumarate Compared With Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
NCT01437540 COMPLETED PHASE3
Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) On A Background Of Tiotropium Bromide
NCT01543919 COMPLETED PHASE2
Effect of the Inhaled Triple Therapies Over the Small Airway in Biomass Exposure
NCT06571942 RECRUITING PHASE4
Long-term Efficacy and Safety of Aclidinium Bromide/Formoterol Fumarate Fixed-Dose Combination
NCT01462942 COMPLETED PHASE3