Clinical trial NCT00528996: An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.
Official title: A Multinational, Randomised, Double-blind, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Comparison Over 24 Weeks of Three Doses (50µg, 100µg, 200µg) of BEA 2180 BR to Tiotropium 5µg, Delivered by the Respimat Inhaler and Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2007-09-14
Enrollment: 2080
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
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 compare the bronchodilator efficacy of three doses (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives include comparing the effects on dyspnea and health status.


Eligibility criteria: Inclusion Criteria:

1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
2. All patients must have a diagnosis of chronic obstructive pulmonary disease (P95 4381) and must meet the following spirometric criteria:

   Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 (post-bronchodilator, 30 minutes post salbutamol/albuterol) \<80% of predicted normal and FEV1 less than or equal to 70% of FVC at the PFTs at Visit 1 (screening).
3. Male or female patients 40 years of age or older.
4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded.
5. Patients must be able to perform technically acceptable pulmonary function tests and electronic PEFR measurements, and must be able to maintain records (Patient Daily Diary) during the study period as required in the protocol.
6. Patients must be able to inhale medication in a competent manner from the Respimat® inhaler (Appendix I)

Exclusion Criteria:

1. Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient ability to participate in the study.
2. Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1.
3. Patients with a recent history (one year or less) of myocardial infarction.
4. Patients with any unstable or life-threatening cardiac arrhythmia.
5. Patients who have been hospitalized for heart failure within the past 3 years.
6. Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
7. Patients with known symptomatic prostatic hyperplasia or bladder neck obstruction as defined in exclusion criteria No. 1.
8. Patients with known narrow-angle glaucoma.
9. Patients with asthma or a history of asthma.
10. Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
11. Patients with known active tuberculosis.
12. Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion No. 1.

Primary outcomes:
measure: Trough Forced Expiratory Volume in One Second (FEV1) Response After 24 Weeks
timeFrame: 40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 24.
Secondary outcomes:
measure: Trough Forced Expiratory Volume in One Second (FEV1) Response After 1, 2, 4, 8, 12, and 18 Weeks
timeFrame: 40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 1, 2, 4, 8, 12 and 18.
measure: Trough Forced Vital Capacity (FVC) Response After 1, 2, 4, 8, 12, 18, and 24 Weeks
timeFrame: 40 minutes (min) and 15 min before drug administration at baseline (Day 1 of treatment period) and Week 1, 2, 4, 8, 12, 18, and 24.
measure: Forced Expiratory Volume in One Second (FEV1) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks
timeFrame: 40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.
measure: Forced Vital Capacity (FVC) Area Under the Curve From 0 to 3 Hours (AUC0-3h) Response After 0, 4, 12 and 24 Weeks
timeFrame: 40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.
measure: Forced Expiratory Volume in One Second (FEV1) Peak Response After 0, 4, 12, and 24 Weeks
timeFrame: 40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.
measure: Forced Vital Capacity (FVC) Peak Response After 0, 4, 12, and 24 Weeks
timeFrame: 40 minutes (min) and 15 min before drug administration and 15 min, 30 min, 60 min, 2 hours, 3 hours after drug administration at Week 0 (Day 1 of treatment period), 4, 12, 24.
measure: Individual Forced Expiratory Volume in One Second (FEV1) Measurements at Each Time Point
timeFrame: 15 minutes (min), 30 min, 1 hour (h), 2 h, 3 h after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24. At 0 min (at drug administration) at Week 4, 12, and 24.
measure: Individual Forced Vital Capacity (FVC) Measurements at Each Time Point
timeFrame: 15 minutes (min), 30 min, 1 hour (h), 2 h, 3 h after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24. At 0 min (at drug administration) at Week 4, 12, and 24.
measure: Trough Forced Expiratory Volume in One Second (FEV1) Response on Day 3 and 5
timeFrame: 40 minutes (min) and 15 min before drug administration at Day 1 (baseline) and Day 3 and 5 of treatment period.
measure: Forced Expiratory Volume in One Second (FEV1) at 3 Minutes and 10 Minutes Following Drug Administration
timeFrame: 3 minutes (min) and 10 after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24.
measure: Forced Vital Capacity (FVC) at 3 Minutes and 10 Minutes Following Drug Administration
timeFrame: 3 minutes (min) and 10 min after drug administration at Week 0 (Day 1 of treatment period), 4, 12, and 24.
measure: Weekly Mean Pre-dose Morning Peak Expiratory Flow Rate (PEFR)
timeFrame: Assessed before drug administration per day during 24 weeks with weekly mean values reporting.
measure: Weekly Mean Evening Peak Expiratory Flow Rate (PEFR)
timeFrame: Assessed at bed time per day during 24 weeks with weekly mean values reporting.
measure: Weekly Mean Number of Occasions of Rescue Therapy Used Per Day (as Occasion Requires (PRN) Salbutamol [Albuterol])
timeFrame: Assessed once per day during 24 weeks with weekly mean values reporting.
measure: Physician's Global Evaluation
timeFrame: At Week 0, 4, 12, and 24.
measure: Transition Dyspnea Index - Functional Impairment Domain Score
timeFrame: At Week 0 (baseline), 4, 12 and 24.
measure: Transition Dyspnea Index - Magnitude of Task Domain Score
timeFrame: At week 0 (baseline), 4, 12 and 24
measure: Transition Dyspnea Index - Magnitude of Effort Domain Score
timeFrame: At Week 0 (baseline), 4, 12 and 24
measure: St. George's Respiratory Questionnaire (SGRQ) Total Score
timeFrame: At Week 0, 4, 12, and 24.
measure: 36-item-health Survey (SF-36) 8 Domain Scores at Baseline
timeFrame: At baseline (Week 0, Day 1 of treatment period).
measure: 36-item-health Survey (SF-36) - Physical Function Domain Score
timeFrame: At Week 4, 12, and 24.
measure: 36-item-health Survey (SF-36) - Role Physical Domain Score
timeFrame: At Week 4, 12, and 24.
measure: 36-item-health Survey (SF-36) - Bodily Pain Domain Score
timeFrame: At Week 4, 12, and 24.
measure: 36-item-health Survey (SF-36) - General Physical Health Domain Score
timeFrame: At Week 4, 12, and 24.
measure: 36-item-health Survey (SF-36) - Vitality Domain Score
timeFrame: At Week 4, 12, and 24.
measure: 36-item-health Survey (SF-36) - Social Functioning Domain Score
timeFrame: At Week 4, 12, and 24.
measure: 36-item-health Survey (SF-36) - Role Emotional Domain Score
timeFrame: At Week 4, 12, and 24.
measure: 36-item-health Survey (SF-36) - General Mental Health Domain Score
timeFrame: At Week 4, 12, and 24.
measure: Number of Patients With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
timeFrame: From first does until 30 days after the end of treatment, up to 205 days.
measure: Incidence Rate of Chronic Obstructive Pulmonary Disease (COPD) Exacerbation
timeFrame: From first does until 30 days after the end of treatment, up to 205 days.
Other outcomes:
Locations:
city: Jasper
country: United States
facility: 1205.14.061 Boehringer Ingelheim Investigational Site
state: Alabama
city: Mobile
country: United States
facility: 1205.14.054 Boehringer Ingelheim Investigational Site
state: Alabama
city: Berkeley
country: United States
facility: 1205.14.042 Boehringer Ingelheim Investigational Site
state: California
city: La Jolla
country: United States
facility: 1205.14.017 Boehringer Ingelheim Investigational Site
state: California
city: Lakewood
country: United States
facility: 1205.14.022 Boehringer Ingelheim Investigational Site
state: California
city: Riverside
country: United States
facility: 1205.14.046 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 1205.14.008 Boehringer Ingelheim Investigational Site
state: California
city: San Diego
country: United States
facility: 1205.14.047 Boehringer Ingelheim Investigational Site
state: California
city: Sepulveda
country: United States
facility: 1205.14.037 Boehringer Ingelheim Investigational Site
state: California
city: Denver
country: United States
facility: 1205.14.041 Boehringer Ingelheim Investigational Site
state: Colorado
city: Fort Collins
country: United States
facility: 1205.14.027 Boehringer Ingelheim Investigational Site
state: Colorado
city: Wheat Ridge
country: United States
facility: 1205.14.034 Boehringer Ingelheim Investigational Site
state: Colorado
city: Stamford
country: United States
facility: 1205.14.050 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Bay Pines
country: United States
facility: 1205.14.013 Boehringer Ingelheim Investigational Site
state: Florida
city: Clearwater
country: United States
facility: 1205.14.016 Boehringer Ingelheim Investigational Site
state: Florida
city: DeLand
country: United States
facility: 1205.14.048 Boehringer Ingelheim Investigational Site
state: Florida
city: Panama City
country: United States
facility: 1205.14.043 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 1205.14.040 Boehringer Ingelheim Investigational Site
state: Florida
city: Atlanta
country: United States
facility: 1205.14.007 Boehringer Ingelheim Investigational Site
state: Georgia
city: Stockbridge
country: United States
facility: 1205.14.053 Boehringer Ingelheim Investigational Site
state: Georgia
city: Coeur d'Alene
country: United States
facility: 1205.14.014 Boehringer Ingelheim Investigational Site
state: Idaho
city: Olathe
country: United States
facility: 1205.14.035 Boehringer Ingelheim Investigational Site
state: Kansas
city: New Orleans
country: United States
facility: 1205.14.057 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: 1205.14.052 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Ann Arbor
country: United States
facility: 1205.14.036 Boehringer Ingelheim Investigational Site
state: Michigan
city: Livonia
country: United States
facility: 1205.14.019 Boehringer Ingelheim Investigational Site
state: Michigan
city: Chesterfield
country: United States
facility: 1205.14.018 Boehringer Ingelheim Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: 1205.14.032 Boehringer Ingelheim Investigational Site
state: Missouri
city: Reno
country: United States
facility: 1205.14.033 Boehringer Ingelheim Investigational Site
state: Nevada
city: Brick
country: United States
facility: 1205.14.044 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Cherry Hill
country: United States
facility: 1205.14.056 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Summit
country: United States
facility: 1205.14.058 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: 1205.14.010 Boehringer Ingelheim Investigational Site
state: New Mexico
city: Larchmont
country: United States
facility: 1205.14.062 Boehringer Ingelheim Investigational Site
state: New York
city: Mineola
country: United States
facility: 1205.14.028 Boehringer Ingelheim Investigational Site
state: New York
city: New Hyde Park
country: United States
facility: 1205.14.030 Boehringer Ingelheim Investigational Site
state: New York
city: New York
country: United States
facility: 1205.14.021 Boehringer Ingelheim Investigational Site
state: New York
city: Toledo
country: United States
facility: 1205.14.059 Boehringer Ingelheim Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: 1205.14.012 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: 1205.14.031 Boehringer Ingelheim Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: 1205.14.003 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 1205.14.004 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Johnston
country: United States
facility: 1205.14.005 Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: 1205.14.029 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Greer
country: United States
facility: 1205.14.055 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: 1205.14.020 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Fort Worth
country: United States
facility: 1205.14.045 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1205.14.025 Boehringer Ingelheim Investigational Site
state: Texas
city: Killeen
country: United States
facility: 1205.14.060 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1205.14.002 Boehringer Ingelheim Investigational Site
state: Texas
city: Richmond
country: United States
facility: 1205.14.023 Boehringer Ingelheim Investigational Site
state: Virginia
city: Richmond
country: United States
facility: 1205.14.024 Boehringer Ingelheim Investigational Site
state: Virginia
city: Roanoke
country: United States
facility: 1205.14.026 Boehringer Ingelheim Investigational Site
state: Virginia
city: Spokane
country: United States
facility: 1205.14.009 Boehringer Ingelheim Investigational Site
state: Washington
city: Spokane
country: United States
facility: 1205.14.039 Boehringer Ingelheim Investigational Site
state: Washington
city: Morgantown
country: United States
facility: 1205.14.001 Boehringer Ingelheim Investigational Site
state: West Virginia
city: Edmonton
country: Canada
facility: 1205.14.151 Boehringer Ingelheim Investigational Site
state: Alberta
city: Vancouver
country: Canada
facility: 1205.14.144 Boehringer Ingelheim Investigational Site
state: British Columbia
city: St. John's
country: Canada
facility: 1205.14.148 Boehringer Ingelheim Investigational Site
state: Newfoundland and Labrador
city: Burlington
country: Canada
facility: 1205.14.143 Boehringer Ingelheim Investigational Site
state: Ontario
city: Downsview
country: Canada
facility: 1205.14.142 Boehringer Ingelheim Investigational Site
state: Ontario
city: Grimsby
country: Canada
facility: 1205.14.150 Boehringer Ingelheim Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: 1205.14.149 Boehringer Ingelheim Investigational Site
state: Ontario
city: Sherbrooke
country: Canada
facility: 1205.14.145 Boehringer Ingelheim Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: 1205.14.146 Boehringer Ingelheim Investigational Site
city: Aschaffenburg
country: Germany
facility: 1205.14.381 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1205.14.164 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1205.14.167 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1205.14.168 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1205.14.172 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1205.14.175 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1205.14.177 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1205.14.178 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1205.14.377 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1205.14.382 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1205.14.387 Boehringer Ingelheim Investigational Site
city: Berlin
country: Germany
facility: 1205.14.388 Boehringer Ingelheim Investigational Site
city: Bonn
country: Germany
facility: 1205.14.165 Boehringer Ingelheim Investigational Site
city: Cottbus
country: Germany
facility: 1205.14.176 Boehringer Ingelheim Investigational Site
city: Dortmund
country: Germany
facility: 1205.14.171 Boehringer Ingelheim Investigational Site
city: Geesthacht
country: Germany
facility: 1205.14.379 Boehringer Ingelheim Investigational Site
city: Gelnhausen
country: Germany
facility: 1205.14.174 Boehringer Ingelheim Investigational Site
city: Hamburg
country: Germany
facility: 1205.14.173 Boehringer Ingelheim Investigational Site
city: Hannover
country: Germany
facility: 1205.14.375 Boehringer Ingelheim Investigational Site
city: Koblenz
country: Germany
facility: 1205.14.378 Boehringer Ingelheim Investigational Site
city: Lübeck
country: Germany
facility: 1205.14.170 Boehringer Ingelheim Investigational Site
city: Mainz
country: Germany
facility: 1205.14.162 Boehringer Ingelheim Investigational Site
city: Marburg
country: Germany
facility: 1205.14.384 Boehringer Ingelheim Investigational Site
city: Minden
country: Germany
facility: 1205.14.166 Boehringer Ingelheim Investigational Site
city: Neumünster
country: Germany
facility: 1205.14.372 Boehringer Ingelheim Investigational Site
city: Neuruppin
country: Germany
facility: 1205.14.386 Boehringer Ingelheim Investigational Site
city: Oschersleben
country: Germany
facility: 1205.14.385 Boehringer Ingelheim Investigational Site
city: Rüdersdorf
country: Germany
facility: 1205.14.169 Boehringer Ingelheim Investigational Site
city: Rüsselsheim
country: Germany
facility: 1205.14.179 Boehringer Ingelheim Investigational Site
city: Saarbrücken
country: Germany
facility: 1205.14.376 Boehringer Ingelheim Investigational Site
city: Schwetzingen
country: Germany
facility: 1205.14.374 Boehringer Ingelheim Investigational Site
city: Witten
country: Germany
facility: 1205.14.371 Boehringer Ingelheim Investigational Site
city: Witten
country: Germany
facility: 1205.14.373 Boehringer Ingelheim Investigational Site
city: Budakeszi
country: Hungary
facility: 1205.14.279 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1205.14.273 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1205.14.283 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1205.14.287 Boehringer Ingelheim Investigational Site
city: Cegled
country: Hungary
facility: 1205.14.286 Boehringer Ingelheim Investigational Site
city: Debrecen
country: Hungary
facility: 1205.14.281 Boehringer Ingelheim Investigational Site
city: Deszk
country: Hungary
facility: 1205.14.272 Boehringer Ingelheim Investigational Site
city: Deszk
country: Hungary
facility: 1205.14.289 Boehringer Ingelheim Investigational Site
city: Erd
country: Hungary
facility: 1205.14.271 Boehringer Ingelheim Investigational Site
city: Gyula
country: Hungary
facility: 1205.14.282 Boehringer Ingelheim Investigational Site
city: Gödöllö
country: Hungary
facility: 1205.14.276 Boehringer Ingelheim Investigational Site
city: Komarom
country: Hungary
facility: 1205.14.277 Boehringer Ingelheim Investigational Site
city: Matrahaza
country: Hungary
facility: 1205.14.278 Boehringer Ingelheim Investigational Site
city: Mosonmagyarovar
country: Hungary
facility: 1205.14.280 Boehringer Ingelheim Investigational Site
city: Sopron
country: Hungary
facility: 1205.14.285 Boehringer Ingelheim Investigational Site
city: Szarvas
country: Hungary
facility: 1205.14.275 Boehringer Ingelheim Investigational Site
city: Szazhalombatta
country: Hungary
facility: 1205.14.288 Boehringer Ingelheim Investigational Site
city: Tatabanya
country: Hungary
facility: 1205.14.284 Boehringer Ingelheim Investigational Site
city: Zalaegerszeg
country: Hungary
facility: 1205.14.274 Boehringer Ingelheim Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: 1205.14.225 Boehringer Ingelheim Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: 1205.14.228 Boehringer Ingelheim Investigational Site
city: Seongdong-gu
country: Korea, Republic of
facility: 1205.14.227 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1205.14.221 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1205.14.222 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1205.14.223 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1205.14.224 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1205.14.226 Boehringer Ingelheim Investigational Site
city: Ciudad de Mexico
country: Mexico
facility: 1205.14.117 Boehringer Ingelheim Investigational Site
city: Cuernavaca, Mor. México
country: Mexico
facility: 1205.14.108 Boehringer Ingelheim Investigational Site
city: Hermosillo, Sonora
country: Mexico
facility: 1205.14.101 Boehringer Ingelheim Investigational Site
city: Metepec
country: Mexico
facility: 1205.14.119 Boehringer Ingelheim Investigational Site
city: Mexico City
country: Mexico
facility: 1205.14.120 Boehringer Ingelheim Investigational Site
city: Monterrey, Nuevo León
country: Mexico
facility: 1205.14.116 Boehringer Ingelheim Investigational Site
city: Monterrey
country: Mexico
facility: 1205.14.102 Boehringer Ingelheim Investigational Site
city: Zapopan, Jal.
country: Mexico
facility: 1205.14.105 Boehringer Ingelheim Investigational Site
city: Chrzanow
country: Poland
facility: 1205.14.251 Boehringer Ingelheim Investigational Site
city: Gdansk
country: Poland
facility: 1205.14.253 Boehringer Ingelheim Investigational Site
city: Gdansk
country: Poland
facility: 1205.14.254 Boehringer Ingelheim Investigational Site
city: Krakow
country: Poland
facility: 1205.14.246 Boehringer Ingelheim Investigational Site
city: Lodz
country: Poland
facility: 1205.14.241 Boehringer Ingelheim Investigational Site
city: Lodz
country: Poland
facility: 1205.14.242 Boehringer Ingelheim Investigational Site
city: Miechow
country: Poland
facility: 1205.14.255 Boehringer Ingelheim Investigational Site
city: Ruda Slaska
country: Poland
facility: 1205.14.248 Boehringer Ingelheim Investigational Site
city: Tarnowskie Gory
country: Poland
facility: 1205.14.249 Boehringer Ingelheim Investigational Site
city: Wilkowice
country: Poland
facility: 1205.14.252 Boehringer Ingelheim Investigational Site
city: Wroclaw
country: Poland
facility: 1205.14.243 Boehringer Ingelheim Investigational Site
city: Wroclaw
country: Poland
facility: 1205.14.244 Boehringer Ingelheim Investigational Site
city: Wroclaw
country: Poland
facility: 1205.14.245 Boehringer Ingelheim Investigational Site
city: Zabrze
country: Poland
facility: 1205.14.247 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1205.14.301 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1205.14.302 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1205.14.303 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1205.14.304 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1205.14.305 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1205.14.306 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1205.14.310 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1205.14.311 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1205.14.312 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1205.14.313 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1205.14.314 Boehringer Ingelheim Investigational Site
city: Yaroslavl
country: Russian Federation
facility: 1205.14.307 Boehringer Ingelheim Investigational Site
city: Yaroslavl
country: Russian Federation
facility: 1205.14.308 Boehringer Ingelheim Investigational Site
city: Yaroslavl
country: Russian Federation
facility: 1205.14.309 Boehringer Ingelheim Investigational Site
city: Badajoz
country: Spain
facility: 1205.14.182 Boehringer Ingelheim Investigational Site
city: Cáceres
country: Spain
facility: 1205.14.186 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1205.14.183 Boehringer Ingelheim Investigational Site
city: Málaga
country: Spain
facility: 1205.14.191 Boehringer Ingelheim Investigational Site
city: Terrassa (Barcelona)
country: Spain
facility: 1205.14.181 Boehringer Ingelheim Investigational Site
city: Torrevieja
country: Spain
facility: 1205.14.190 Boehringer Ingelheim Investigational Site
city: Valencia
country: Spain
facility: 1205.14.189 Boehringer Ingelheim Investigational Site
city: Vigo
country: Spain
facility: 1205.14.187 Boehringer Ingelheim Investigational Site
city: Changhua
country: Taiwan
facility: 1205.14.207 Boehringer Ingelheim Investigational Site
city: Chiayi City
country: Taiwan
facility: 1205.14.208 Boehringer Ingelheim Investigational Site
city: Kaohsiung County
country: Taiwan
facility: 1205.14.209 Boehringer Ingelheim Investigational Site
city: Kaohsiung
country: Taiwan
facility: 1205.14.210 Boehringer Ingelheim Investigational Site
city: Taichung
country: Taiwan
facility: 1205.14.205 Boehringer Ingelheim Investigational Site
city: Taichung
country: Taiwan
facility: 1205.14.206 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1205.14.202 Boehringer Ingelheim Investigational Site
city: Taipei
country: Taiwan
facility: 1205.14.204 Boehringer Ingelheim Investigational Site
city: Taoyuan County
country: Taiwan
facility: 1205.14.201 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Abrahams R, Moroni-Zentgraf P, Ramsdell J, Schmidt H, Joseph E, Karpel J. Safety and efficacy of the once-daily anticholinergic BEA2180 compared with tiotropium in patients with COPD. Respir Med. 2013 Jun;107(6):854-62. doi: 10.1016/j.rmed.2013.02.005. Epub 2013 Mar 13.