Clinical trial NCT00793624: Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease I
Official title: A Randomised, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety of 48 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL (5 µg [2 Actuations of 2.5 ug] and 10 ug [2 Actuations of 5 ug]) Delivered by the Respimat® Inhaler, and 48 Weeks of Twice Daily Foradil® (12 µg) Delivered by the Aerolizer® Inhaler, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-11-19
Enrollment: 906
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24
measure: Trough FEV1 Response at Week 24
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.
measure: Mahler Transitional Dyspnea Index Focal Score at 24 Weeks
timeFrame: Baseline, Week 24
measure: Mahler Transitional Dyspnea Index Focal Score at 24 Weeks for Combined Analysis
timeFrame: Baseline, Week 24
Secondary outcomes:
measure: Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks
timeFrame: Baseline, Week 24
measure: Saint George's Respiratory Questionnaire (SGRQ) Total Score at 12 Weeks
timeFrame: Baseline, Week 12
measure: Saint George's Respiratory Questionnaire (SGRQ) Total Score at 48 Weeks
timeFrame: Baseline, Week 48
measure: Saint George's Respiratory Questionnaire (SGRQ) Total Score at 24 Weeks for Combined Analysis
timeFrame: Baseline, Week 24
measure: Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2
measure: Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6
measure: Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12
measure: Forced Expiratory Volume in One Second (FEV1) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48
measure: Trough FEV1 Response at Week 2
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.
measure: Trough FEV1 Response at Week 6
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.
measure: Trough FEV1 Response at Week 12
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.
measure: Trough FEV1 Response at Week 18
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.
measure: Trough FEV1 Response at Week 32
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.
measure: Trough FEV1 Response at Week 40
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.
measure: Trough FEV1 Response at Week 48
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.
measure: Peak FEV1 (0-3h) Response After 2 Weeks
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks
measure: Peak FEV1 (0-3h) Response After 6 Weeks
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks
measure: Peak FEV1 (0-3h) Response After 12 Weeks
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks
measure: Peak FEV1 (0-3h) Response After 24 Weeks
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks
measure: Peak FEV1 (0-3h) Response After 48 Weeks
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks
measure: Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 2 Weeks
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 2
measure: Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 6 Weeks
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 6
measure: Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 12 Weeks
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 12
measure: Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 24 Weeks
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 24
measure: Forced Vital Capacity (FVC) Area Under Curve 0-3 Hour (h) (AUC 0-3h) Response at 48 Weeks
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose on Week 48
measure: Trough FVC Response at Week 2
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 2.
measure: Trough FVC Response at Week 6
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 6.
measure: Trough FVC Response at Week 12
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 12.
measure: Trough FVC Response at Week 18
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 18.
measure: Trough FVC Response at Week 24
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 24.
measure: Trough FVC Response at Week 32
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 32.
measure: Trough FVC Response at Week 48
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 48.
measure: Trough FVC Response at Week 40
timeFrame: 1 h and 10 min prior to dose on the first day of randomized treatment (baseline) and -1 h (if available) and - 10 mins prior to study drug at week 40.
measure: Peak FVC (0-3h) Response After 2 Weeks
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 2 weeks
measure: Peak FVC (0-3h) Response After 6 Weeks
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 6 weeks
measure: Peak FVC (0-3h) Response After 12 Weeks
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 12 weeks
measure: Peak FVC (0-3h) Response After 24 Weeks
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 24 weeks
measure: Peak FVC (0-3h) Response After 48 Weeks
timeFrame: 1 hour (h) and 10 minutes (min) prior to dose on the first day of randomized treatment (baseline) to -10 min, 5 min, 15 min, 30 min, 1 h, 2 h, and 3 h relative to dose after 48 weeks
measure: Peak Expiratory Flow Rate (PEFR) at Week 24
timeFrame: Week 24
measure: Use of Rescue Medication at Week 24
timeFrame: Week 24
measure: Patient's Global Rating (PGR) at 6 Weeks
timeFrame: Week 6
measure: Patient's Global Rating (PGR) at 12 Weeks
timeFrame: Week 12
measure: Patient's Global Rating (PGR) at 24 Weeks
timeFrame: Week 24
measure: Patient's Global Rating (PGR) at 48 Weeks
timeFrame: Week 48
measure: Mahler Transitional Dyspnea Index Focal Score at 6 Weeks
timeFrame: Baseline, Week 6
measure: Mahler Transitional Dyspnea Index Focal Score at 12 Weeks
timeFrame: Baseline, Week 12
measure: Mahler Transitional Dyspnea Index Focal Score at 18 Weeks
timeFrame: Baseline, Week 18
measure: Mahler Transitional Dyspnea Index Focal Score at 32 Weeks
timeFrame: Baseline, Week 32
measure: Mahler Transitional Dyspnea Index Focal Score at 40 Weeks
timeFrame: Baseline, Week 40
measure: Mahler Transitional Dyspnea Index Focal Score at 48 Weeks
timeFrame: Baseline, Week 48
measure: Time to First Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
timeFrame: Baseline to end of study at 48 weeks.
measure: Time to First Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation Leading to Hospitalization
timeFrame: Baseline to end of study at 48 weeks.
measure: Time to First Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbation
timeFrame: Baseline to end of study at 48 weeks.
measure: Number of COPD Exacerbations
timeFrame: Baseline to end of study at week 48 visit
measure: Number of COPD Exacerbations Requiring Hospitalization
timeFrame: Baseline to end of study at week 48 visit
measure: Number of Moderate Chronic Obstructive Pulmonary Disease (CPOD) Exacerbations
timeFrame: Baseline to end of study at 48 weeks.
measure: Absolute Plasma Concentrations
timeFrame: within 2 hours before first drug administration and 10 minutes post-dose at week 6, 12 and 18
measure: Changes in Safety Parameters Related to Treatment
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Capital Federal
country: Argentina
facility: 1222.13.2401 Boehringer Ingelheim Investigational Site
city: Capital Federal
country: Argentina
facility: 1222.13.2403 Boehringer Ingelheim Investigational Site
city: Mar del Plata
country: Argentina
facility: 1222.13.2402 Boehringer Ingelheim Investigational Site
city: Monte Grande
country: Argentina
facility: 1222.13.2404 Boehringer Ingelheim Investigational Site
city: Juiz de Fora
country: Brazil
facility: 1222.13.2502 Boehringer Ingelheim Investigational Site
city: Rio de Janeiro
country: Brazil
facility: 1222.13.2503 Boehringer Ingelheim Investigational Site
city: Rio de Janeiro
country: Brazil
facility: 1222.13.2505 Boehringer Ingelheim Investigational Site
city: Sao Paulo
country: Brazil
facility: 1222.13.2501 Boehringer Ingelheim Investigational Site
city: Sao Paulo
country: Brazil
facility: 1222.13.2504 Boehringer Ingelheim Investigational Site
city: Calgary
country: Canada
facility: 1222.13.1408 Boehringer Ingelheim Investigational Site
state: Alberta
city: Chilliwack
country: Canada
facility: 1222.13.1407 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Downsview
country: Canada
facility: 1222.13.1403 Boehringer Ingelheim Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: 1222.13.1412 Boehringer Ingelheim Investigational Site
state: Ontario
city: Niagara Falls
country: Canada
facility: 1222.13.1401 Boehringer Ingelheim Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: 1222.13.1410 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1222.13.1413 Boehringer Ingelheim Investigational Site
state: Ontario
city: La Malbaie
country: Canada
facility: 1222.13.1404 Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: 1222.13.1411 Boehringer Ingelheim Investigational Site
state: Quebec
city: Point Claire
country: Canada
facility: 1222.13.1406 Boehringer Ingelheim Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: 1222.13.1402 Boehringer Ingelheim Investigational Site
state: Saskatchewan
city: Dubrovnik
country: Croatia
facility: 1222.13.3502 Boehringer Ingelheim Investigational Site
city: Rijeka
country: Croatia
facility: 1222.13.3503 Boehringer Ingelheim Investigational Site
city: Split
country: Croatia
facility: 1222.13.3504 Boehringer Ingelheim Investigational Site
city: Zagreb
country: Croatia
facility: 1222.13.3501 Boehringer Ingelheim Investigational Site
city: Beroun
country: Czech Republic
facility: 1222.13.3401 Boehringer Ingelheim Investigational Site
city: Cesky Tesin
country: Czech Republic
facility: 1222.13.3403 Boehringer Ingelheim Investigational Site
city: Tabor
country: Czech Republic
facility: 1222.13.3402 Boehringer Ingelheim Investigational Site
city: Aalborg
country: Denmark
facility: 1222.13.2003 Boehringer Ingelheim Investigational Site
city: Hvidovre
country: Denmark
facility: 1222.13.2002 Boehringer Ingelheim Investigational Site
city: Silkeborg
country: Denmark
facility: 1222.13.2001 Boehringer Ingelheim Investigational Site
city: Lahti
country: Finland
facility: 1222.13.2103 Boehringer Ingelheim Investigational Site
city: Tampere
country: Finland
facility: 1222.13.2101 Boehringer Ingelheim Investigational Site
city: Turku
country: Finland
facility: 1222.13.2102 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1222.13.1502 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1222.13.1503 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1222.13.1506 Boehringer Ingelheim Investigational Site
city: Dortmund
country: Germany
facility: 1222.13.1511 Boehringer Ingelheim Investigational Site
city: Essen
country: Germany
facility: 1222.13.1514 Boehringer Ingelheim Investigational Site
city: Großhansdorf
country: Germany
facility: 1222.13.1509 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1222.13.1508 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1222.13.1510 Boehringer Ingelheim Investigational Site
city: Kiel
country: Germany
facility: 1222.13.1512 Boehringer Ingelheim Investigational Site
city: Köln
country: Germany
facility: 1222.13.1501 Boehringer Ingelheim Investigational Site
city: Reinfeld
country: Germany
facility: 1222.13.1505 Boehringer Ingelheim Investigational Site
city: Schwerin
country: Germany
facility: 1222.13.1507 Boehringer Ingelheim Investigational Site
city: Kowloon
country: Hong Kong
facility: 1222.13.2901 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1222.13.2804 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 1222.13.2803 Boehringer Ingelheim Investigational Site
city: Coimbatore-
country: India
facility: 1222.13.2806 Boehringer Ingelheim Investigational Site
city: Hyderabad
country: India
facility: 1222.13.2810 Boehringer Ingelheim Investigational Site
city: Indore
country: India
facility: 1222.13.2801 Boehringer Ingelheim Investigational Site
city: Indore
country: India
facility: 1222.13.2807 Boehringer Ingelheim Investigational Site
city: Jaipur
country: India
facility: 1222.13.2805 Boehringer Ingelheim Investigational Site
city: Ludhiana, Punjab
country: India
facility: 1222.13.2802 Boehringer Ingelheim Investigational Site
city: Mumbai
country: India
facility: 1222.13.2809 Boehringer Ingelheim Investigational Site
city: Mumbai
country: India
facility: 1222.13.2812 Boehringer Ingelheim Investigational Site
city: Pune
country: India
facility: 1222.13.2811 Boehringer Ingelheim Investigational Site
city: Catania
country: Italy
facility: 1222.13.1704 Boehringer Ingelheim Investigational Site
city: Genova
country: Italy
facility: 1222.13.1702 Boehringer Ingelheim Investigational Site
city: Pisa
country: Italy
facility: 1222.13.1701 Boehringer Ingelheim Investigational Site
city: Siena
country: Italy
facility: 1222.13.1705 Boehringer Ingelheim Investigational Site
city: Trieste
country: Italy
facility: 1222.13.1703 Boehringer Ingelheim Investigational Site
city: Gwangju
country: Korea, Republic of
facility: 1222.13.2701 Boehringer Ingelheim Investigational Site
city: Incheon
country: Korea, Republic of
facility: 1222.13.2702 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1222.13.2703 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1222.13.2705 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1222.13.2706 Boehringer Ingelheim Investigational Site
city: Suwon
country: Korea, Republic of
facility: 1222.13.2704 Boehringer Ingelheim Investigational Site
city: Batu Caves
country: Malaysia
facility: 1222.13.3103 Boehringer Ingelheim Investigational Site
city: Kota Kinabalu
country: Malaysia
facility: 1222.13.3101 Boehringer Ingelheim Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: 1222.13.3102 Boehringer Ingelheim Investigational Site
city: Kuantan
country: Malaysia
facility: 1222.13.3104 Boehringer Ingelheim Investigational Site
city: Bergen
country: Norway
facility: 1222.13.2201 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 1222.13.2202 Boehringer Ingelheim Investigational Site
city: Cebu
country: Philippines
facility: 1222.13.3203 Boehringer Ingelheim Investigational Site
city: Quezon City
country: Philippines
facility: 1222.13.3201 Boehringer Ingelheim Investigational Site
city: Quezon City
country: Philippines
facility: 1222.13.3202 Boehringer Ingelheim Investigational Site
city: Durban
country: South Africa
facility: 1222.13.2302 Boehringer Ingelheim Investigational Site
city: Pretoria
country: South Africa
facility: 1222.13.2301 Boehringer Ingelheim Investigational Site
city: Aranjuez
country: Spain
facility: 1222.13.1803 Boehringer Ingelheim Investigational Site
city: Elda
country: Spain
facility: 1222.13.1806 Boehringer Ingelheim Investigational Site
city: Els Hostalets de Balenyà
country: Spain
facility: 1222.13.1802 Boehringer Ingelheim Investigational Site
city: Pozuelo de Alarcón
country: Spain
facility: 1222.13.1804 Boehringer Ingelheim Investigational Site
city: Valladolid
country: Spain
facility: 1222.13.1805 Boehringer Ingelheim Investigational Site
city: Vic (Barcelona)
country: Spain
facility: 1222.13.1801 Boehringer Ingelheim Investigational Site
city: Boden
country: Sweden
facility: 1222.13.1901 Boehringer Ingelheim Investigational Site
city: Sundsvall
country: Sweden
facility: 1222.13.1902 Boehringer Ingelheim Investigational Site
city: Bangkok
country: Thailand
facility: 1222.13.3302 Boehringer Ingelheim Investigational Site
city: Bangkok
country: Thailand
facility: 1222.13.3303 Boehringer Ingelheim Investigational Site
city: Chiang Mai
country: Thailand
facility: 1222.13.3301 Boehringer Ingelheim Investigational Site
city: Ivano-Frankivsk
country: Ukraine
facility: 1222.13.3602 Boehringer Ingelheim Investigational Site
city: Kharkiv
country: Ukraine
facility: 1222.13.3601 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1222.13.3603 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.