Clinical trial NCT00796653: Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease II
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: 2008-11-24
Enrollment: 937
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 48 Weeks
timeFrame: Baseline, Week 48
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 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 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 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: 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: Changes in Safety Parameters Related to Treatment
timeFrame: 48 weeks
measure: Absolute Plasma Concentrations
timeFrame: within 2 hours before first study drug administration and 10 minutes post-dose at week 6, 12 and 18
Other outcomes:
Locations:
city: Capital Federal
country: Argentina
facility: 1222.14.5004 Boehringer Ingelheim Investigational Site
city: Florencio Varela
country: Argentina
facility: 1222.14.5005 Boehringer Ingelheim Investigational Site
city: Mar del Plata
country: Argentina
facility: 1222.14.5003 Boehringer Ingelheim Investigational Site
city: Mendoza
country: Argentina
facility: 1222.14.5001 Boehringer Ingelheim Investigational Site
city: Quilmes
country: Argentina
facility: 1222.14.5002 Boehringer Ingelheim Investigational Site
city: Florianopolis
country: Brazil
facility: 1222.14.5106 Boehringer Ingelheim Investigational Site
city: Porto Alegre
country: Brazil
facility: 1222.14.5101 Boehringer Ingelheim Investigational Site
city: Porto Alegre
country: Brazil
facility: 1222.14.5103 Boehringer Ingelheim Investigational Site
city: Porto Alegre
country: Brazil
facility: 1222.14.5104 Boehringer Ingelheim Investigational Site
city: Recife
country: Brazil
facility: 1222.14.5102 Boehringer Ingelheim Investigational Site
city: Sao Paulo
country: Brazil
facility: 1222.14.5105 Boehringer Ingelheim Investigational Site
city: Calgary
country: Canada
facility: 1222.14.4005 Boehringer Ingelheim Investigational Site
state: Alberta
city: Kelowna
country: Canada
facility: 1222.14.4002 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: 1222.14.4004 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Moncton
country: Canada
facility: 1222.14.4009 Boehringer Ingelheim Investigational Site
state: New Brunswick
city: St. John's
country: Canada
facility: 1222.14.4010 Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: Grimsby
country: Canada
facility: 1222.14.4008 Boehringer Ingelheim Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: 1222.14.4014 Boehringer Ingelheim Investigational Site
state: Ontario
city: Newmarket
country: Canada
facility: 1222.14.4007 Boehringer Ingelheim Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: 1222.14.4013 Boehringer Ingelheim Investigational Site
state: Ontario
city: Scarborough
country: Canada
facility: 1222.14.4001 Boehringer Ingelheim Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: 1222.14.4012 Boehringer Ingelheim Investigational Site
state: Quebec
city: Sherbrooke
country: Canada
facility: 1222.14.4015 Boehringer Ingelheim Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: 1222.14.4011 Boehringer Ingelheim Investigational Site
state: Saskatchewan
city: Quebec
country: Canada
facility: 1222.14.4006 Boehringer Ingelheim Investigational Site
city: Brno
country: Czech Republic
facility: 1222.14.6004 Boehringer Ingelheim Investigational Site
city: Hradec Kralove
country: Czech Republic
facility: 1222.14.6003 Boehringer Ingelheim Investigational Site
city: Kyjov
country: Czech Republic
facility: 1222.14.6002 Boehringer Ingelheim Investigational Site
city: Znojmo
country: Czech Republic
facility: 1222.14.6001 Boehringer Ingelheim Investigational Site
city: Helsingør
country: Denmark
facility: 1222.14.4602 Boehringer Ingelheim Investigational Site
city: Hillerød
country: Denmark
facility: 1222.14.4601 Boehringer Ingelheim Investigational Site
city: Roskilde
country: Denmark
facility: 1222.14.4603 Boehringer Ingelheim Investigational Site
city: Espoo
country: Finland
facility: 1222.14.4702 Boehringer Ingelheim Investigational Site
city: HUS
country: Finland
facility: 1222.14.4701 Boehringer Ingelheim Investigational Site
city: Lohja
country: Finland
facility: 1222.14.4703 Boehringer Ingelheim Investigational Site
city: Aschaffenburg
country: Germany
facility: 1222.14.4106 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1222.14.4112 Boehringer Ingelheim Investigational Site
city: Frankfurt
country: Germany
facility: 1222.14.4103 Boehringer Ingelheim Investigational Site
city: Frankfurt
country: Germany
facility: 1222.14.4110 Boehringer Ingelheim Investigational Site
city: Gelnhausen
country: Germany
facility: 1222.14.4108 Boehringer Ingelheim Investigational Site
city: Kelkheim
country: Germany
facility: 1222.14.4107 Boehringer Ingelheim Investigational Site
city: Lübeck
country: Germany
facility: 1222.14.4114 Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: 1222.14.4111 Boehringer Ingelheim Investigational Site
city: Minden
country: Germany
facility: 1222.14.4113 Boehringer Ingelheim Investigational Site
city: Mönchengladbach
country: Germany
facility: 1222.14.4109 Boehringer Ingelheim Investigational Site
city: Rodgau-Dudenhofen
country: Germany
facility: 1222.14.4104 Boehringer Ingelheim Investigational Site
city: Wiesloch
country: Germany
facility: 1222.14.4105 Boehringer Ingelheim Investigational Site
city: Hong Kong
country: Hong Kong
facility: 1222.14.5501 Boehringer Ingelheim Investigational Site
city: Coimbatore
country: India
facility: 1222.14.5412 Boehringer Ingelheim Investigational Site
city: Hyderabad
country: India
facility: 1222.14.5406 Boehringer Ingelheim Investigational Site
city: Indore
country: India
facility: 1222.14.5402 Boehringer Ingelheim Investigational Site
city: Jaipur
country: India
facility: 1222.14.5405 Boehringer Ingelheim Investigational Site
city: Jaipur
country: India
facility: 1222.14.5409 Boehringer Ingelheim Investigational Site
city: Mangalore
country: India
facility: 1222.14.5403 Boehringer Ingelheim Investigational Site
city: Mysore
country: India
facility: 1222.14.5407 Boehringer Ingelheim Investigational Site
city: Nagpur
country: India
facility: 1222.14.5404 Boehringer Ingelheim Investigational Site
city: Noida
country: India
facility: 1222.14.5408 Boehringer Ingelheim Investigational Site
city: Pune
country: India
facility: 1222.14.5401 Boehringer Ingelheim Investigational Site
city: Vellore
country: India
facility: 1222.14.5410 Boehringer Ingelheim Investigational Site
city: Cassano Delle Murge (ba)
country: Italy
facility: 1222.14.4301 Boehringer Ingelheim Investigational Site
city: Genova
country: Italy
facility: 1222.14.4302 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1222.14.4304 Boehringer Ingelheim Investigational Site
city: Parma
country: Italy
facility: 1222.14.4305 Boehringer Ingelheim Investigational Site
city: Roma
country: Italy
facility: 1222.14.4303 Boehringer Ingelheim Investigational Site
city: Bucheon
country: Korea, Republic of
facility: 1222.14.5301 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1222.14.5302 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1222.14.5305 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1222.14.5306 Boehringer Ingelheim Investigational Site
city: Uijeongbu
country: Korea, Republic of
facility: 1222.14.5304 Boehringer Ingelheim Investigational Site
city: Wonju
country: Korea, Republic of
facility: 1222.14.5303 Boehringer Ingelheim Investigational Site
city: Georgetown, Pulau Pinang
country: Malaysia
facility: 1222.14.5701 Boehringer Ingelheim Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: 1222.14.5703 Boehringer Ingelheim Investigational Site
city: Kuching, Sarawak
country: Malaysia
facility: 1222.14.5702 Boehringer Ingelheim Investigational Site
city: Fredrikstad
country: Norway
facility: 1222.14.4802 Boehringer Ingelheim Investigational Site
city: SKI
country: Norway
facility: 1222.14.4801 Boehringer Ingelheim Investigational Site
city: Iloilo City
country: Philippines
facility: 1222.14.5802 Boehringer Ingelheim Investigational Site
city: Iloilo City
country: Philippines
facility: 1222.14.5803 Boehringer Ingelheim Investigational Site
city: Manila
country: Philippines
facility: 1222.14.5801 Boehringer Ingelheim Investigational Site
city: Brasov
country: Romania
facility: 1222.14.6103 Boehringer Ingelheim Investigational Site
city: Constanta
country: Romania
facility: 1222.14.6102 Boehringer Ingelheim Investigational Site
city: Iasi
country: Romania
facility: 1222.14.6101 Boehringer Ingelheim Investigational Site
city: Petrozavodsk
country: Russian Federation
facility: 1222.14.6203 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1222.14.6201 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1222.14.6202 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1222.14.4901 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1222.14.4902 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1222.14.4401 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1222.14.4402 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1222.14.4406 Boehringer Ingelheim Investigational Site
city: Mérida
country: Spain
facility: 1222.14.4405 Boehringer Ingelheim Investigational Site
city: Palma de Mallorca
country: Spain
facility: 1222.14.4403 Boehringer Ingelheim Investigational Site
city: Terrassa (Barcelona)
country: Spain
facility: 1222.14.4407 Boehringer Ingelheim Investigational Site
city: Boden
country: Sweden
facility: 1222.14.4501 Boehringer Ingelheim Investigational Site
city: Göteboerg
country: Sweden
facility: 1222.14.4503 Boehringer Ingelheim Investigational Site
city: Lund
country: Sweden
facility: 1222.14.4502 Boehringer Ingelheim Investigational Site
city: Bangkok
country: Thailand
facility: 1222.14.5904 Boehringer Ingelheim Investigational Site
city: Khon Kaen
country: Thailand
facility: 1222.14.5901 Boehringer Ingelheim Investigational Site
city: Songkla
country: Thailand
facility: 1222.14.5902 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.