Clinical trial NCT00400153: Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Safety and Efficacy of Combivent Respimat in 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: 2006-11-16
Enrollment: 1480
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 compare the effect of ipratropium bromide/salbutamol inhalation spray combination administered by the Respimat® inhaler (20 mcg/100 mcg), ipratropium bromide inhalation spray administered by the Respimat® inhaler (20 mcg), and COMBIVENT® MDI administered q.i.d on FEV1 at intervals over a treatment period of 12 weeks in patients with COPD. Specifically, non-inferiority of Combivent Respimat® to COMBIVENT® MDI in FEV1 AUC from 0 to 6 hours , superiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 0 to 4 hours, and non-inferiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 4 to 6 hours will be analyzed. In addition, steady state pharmacokinetics over one dosing interval following 4 weeks of therapy will be characterized in a subgroup of patients.


Eligibility criteria: Inclusion Criteria:

Outpatients of either sex, 40 years or older, with a diagnosis of COPD (FEV1 65% predicted normal and FEV1/FVC 70%).

Exclusion Criteria:

Patients with significant diseases other than COPD that 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's ability to participate in the study, with a history of asthma or allergic rhinitis, who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy or using oral corticosteroid me dication at unstable doses (i.e., less than 6 weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day will be excluded.

Primary outcomes:
measure: FEV1 AUC0-6 at Day 85
timeFrame: Before drug administration to 6 hours after drug administration on Day 85
measure: FEV1 AUC0-4 at Day 85
timeFrame: Before drug administration to 4 hours after drug administration on Day 85
measure: FEV1 AUC4-6 at Day 85
timeFrame: Between 4 hours and 6 hours after drug administration on Day 85
Secondary outcomes:
measure: FEV1 AUC0-6 at Day 1
timeFrame: Before drug administration to 6 hours after drug administration on Day 1
measure: FEV1 AUC0-6 at Day 29
timeFrame: Before drug administration to 6 hours after drug administration on Day 29
measure: FEV1 AUC0-6 at Day 57
timeFrame: Before drug administration to 6 hours after drug administration on Day 57
measure: FEV1 AUC0-4 at Day 1
timeFrame: Before drug administration to 4 hours after drug administration on Day 1
measure: FEV1 AUC0-4 at Day 29
timeFrame: Before drug administration to 4 hours after drug administration on Day 29
measure: FEV1 AUC0-4 at Day 57
timeFrame: Before drug administration to 4 hours after drug administration on Day 57
measure: FEV1 AUC4-6 at Day 1
timeFrame: Between 4 hours and 6 hours after drug administration on Day 1
measure: FEV1 AUC4-6 at Day 29
timeFrame: Between 4 hours and 6 hours after drug administration on Day 29
measure: FEV1 AUC4-6 at Day 57
timeFrame: Between 4 hours and 6 hours after drug administration on Day 57
measure: Peak FEV1 Response at Day 1
timeFrame: Within the first 2-hour post-treatment interval on Day 1
measure: Peak FEV1 Response at Day 29
timeFrame: Within the first 2-hour post-treatment interval on Day 29
measure: Peak FEV1 Response at Day 57
timeFrame: Within the first 2-hour post-treatment interval on Day 57
measure: Peak FEV1 Response at Day 85
timeFrame: Within the first 2-hour post-treatment interval on Day 85
measure: Time to Onset of Therapeutic FEV1 Response at Day 1
timeFrame: Within the first 2-hour post-treatment interval at Day 1
measure: Time to Onset of Therapeutic FEV1 Response at Day 29
timeFrame: Within the first 2-hour post-treatment interval at Day 29
measure: Time to Onset of Therapeutic FEV1 Response at Day 57
timeFrame: Within the first 2-hour post-treatment interval at Day 57
measure: Time to Onset of Therapeutic FEV1 Response at Day 85
timeFrame: Within the first 2-hour post-treatment interval at Day 85
measure: Duration of Therapeutic FEV1 Response at Day 1
timeFrame: During the 6-hour observation period after drug administration at Day 1
measure: Duration of Therapeutic FEV1 Response at Day 29
timeFrame: During the 6-hour observation period after drug administration at Day 29
measure: Duration of Therapeutic FEV1 Response at Day 57
timeFrame: During the 6-hour observation period after drug administration at Day 57
measure: Duration of Therapeutic FEV1 Response at Day 85
timeFrame: During the 6-hour observation period after drug administration at Day 85
measure: Time to Peak FEV1 Response at Day 1
timeFrame: Within the 6-hour post-treatment observation period at Day 1
measure: Time to Peak FEV1 Response at Day 29
timeFrame: Within the 6-hour post-treatment observation period at Day 29
measure: Time to Peak FEV1 Response at Day 57
timeFrame: Within the 6-hour post-treatment observation period at Day 57
measure: Time to Peak FEV1 Response at Day 85
timeFrame: Within the 6-hour post-treatment observation period at Day 85
measure: FVC AUC0-6 at Day 1
timeFrame: Before drug administration to 6 hours after drug administration at Day 1
measure: FVC AUC0-6 at Day 29
timeFrame: Before drug administration to 6 hours after drug administration at Day 29
measure: FVC AUC0-6 at Day 57
timeFrame: Before drug administration to 6 hours after drug administration on Day 57
measure: FVC AUC0-6 at Day 85
timeFrame: Before drug administration to 6 hours after drug administration on Day 85
measure: FVC AUC0-4 at Day 1
timeFrame: Before drug administration to 4 hours after drug administration on Day 1
measure: FVC AUC0-4 at Day 29
timeFrame: Before drug administration to 4 hours after drug administration on Day 29
measure: FVC AUC0-4 at Day 57
timeFrame: Before drug administration to 4 hours after drug administration on Day 57
measure: FVC AUC0-4 at Day 85
timeFrame: Before drug administration to 4 hours after drug administration on Day 85
measure: FVC AUC4-6 at Day 1
timeFrame: Between 4 hours and 6 hours after drug administration on Day 1
measure: FVC AUC4-6 at Day 29
timeFrame: Between 4 hours and 6 hours after drug administration on Day 29
measure: FVC AUC4-6 at Day 57
timeFrame: Between 4 hours and 6 hours after drug administration on Day 57
measure: FVC AUC4-6 at Day 85
timeFrame: Between 4 hours and 6 hours after drug administration on Day 85
measure: Peak FVC Response at Day 1
timeFrame: Within the first 2-hour post-treatment interval at Day 1
measure: Peak FVC Response at Day 29
timeFrame: Within the first 2-hour post-treatment interval at Day 29
measure: Peak FVC Response at Day 57
timeFrame: Within the first 2-hour post-treatment interval at Day 57
measure: Peak FVC Response at Day 85
timeFrame: Within the first 2-hour post-treatment interval at Day 85
measure: Rescue Medication Use on Pulmonary Test Day 1
timeFrame: During the 6-hour pulmonary function testing after drug administration on Day 1
measure: Rescue Medication Use on Pulmonary Test Day 29
timeFrame: During the 6-hour pulmonary function testing after drug administration on Day 29
measure: Rescue Medication Use on Pulmonary Test Day 57
timeFrame: During the 6-hour pulmonary function testing after drug administration on Day 57
measure: Rescue Medication Use on Pulmonary Test Day 85
timeFrame: During the 6-hour pulmonary function testing after drug administration on Day 85
measure: Night-time Rescue Medication Use
timeFrame: During the 2-week baseline washout period and the 12-week treatment period
measure: Daytime Rescue Medication Use
timeFrame: During the 2-week baseline washout period and the 12-week treatment period
measure: Night-time Symptom Score
timeFrame: During the 2-week baseline washout period and the 12-week treatment period
measure: Daytime Symptom Score
timeFrame: During the 2-week baseline washout period and the 12-week treatment period
measure: Trough Peak Expiratory Flow Rate (PEFR)
timeFrame: During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication
measure: Physician's Global Evaluation Score on Pulmonary Function Testing Day 29
timeFrame: Prior to pulmonary function test on Day 29
measure: Physician's Global Evaluation Score on Pulmonary Function Testing Day 57
timeFrame: Prior to pulmonary function test on Day 57
measure: Physician's Global Evaluation Score on Pulmonary Function Testing Day 85
timeFrame: Prior to pulmonary function test on Day 85
measure: Percentage of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the On-treatment Period
timeFrame: During the 12-week on-treatment period
measure: COPD Exacerbation Rate During the On-treatment Period
timeFrame: During the 12-week on-treatment period
measure: COPD Exacerbation During the On-treatment Period
timeFrame: During the 12-week on-treatment period
measure: Frequency Distribution of Satisfaction Rating With Inhaler Attributes
timeFrame: 12 weeks
measure: Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine
timeFrame: 12 weeks
measure: Mean Rating Scores of Satisfaction With Inhaler - Feeling That the Inhaled Dose Goes to the Lung
timeFrame: 12 weeks
measure: Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left
timeFrame: 12 weeks
measure: Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably
timeFrame: 12 weeks
measure: Mean Rating Scores of Satisfaction With Inhaler - Ease of Inhaling a Dose From the Inhaler
timeFrame: 12 weeks
measure: Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use
timeFrame: 12 weeks
measure: Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable
timeFrame: 12 weeks
measure: Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler
timeFrame: 12 weeks
measure: Mean Rating Scores of Satisfaction With Inhaler - Speed of Medicine Coming Out of the Inhaler
timeFrame: 12 weeks
measure: Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler
timeFrame: 12 weeks
measure: Device Preference (Respimat or MDI)
timeFrame: 12 weeks
measure: Rating of Action of Turning Clear Base of Respimat
timeFrame: 12 weeks
measure: Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State
timeFrame: Before drug administration to 6 hours after drug administration on Day 29
measure: Noncompartmental Parameters of Albuterol at Steady State
timeFrame: Before drug administration to 6 hours after drug administration on Day 29
measure: Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-2 Hours
timeFrame: Before drug administration to 2 hours after drug administration on Day 29
measure: Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-2 Hours
timeFrame: Before drug administration to 2 hours after drug administration on Day 29
measure: Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-6 Hours
timeFrame: Before drug administration to 6 hours after drug administration on Day 26
measure: Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-6 Hours
timeFrame: Before drug administration to 6 hours after drug administration on Day 29
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: 1012.56.01006 Boehringer Ingelheim Investigational Site
state: Alabama
city: Jasper
country: United States
facility: 1012.56.01051 Boehringer Ingelheim Investigational Site
state: Alabama
city: Mobile
country: United States
facility: 1012.56.01071 Boehringer Ingelheim Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: 1012.56.01039 Boehringer Ingelheim Investigational Site
state: Arizona
city: Lakewood
country: United States
facility: 1012.56.01012 Boehringer Ingelheim Investigational Site
state: California
city: Los Angeles
country: United States
facility: 1012.56.01029 Boehringer Ingelheim Investigational Site
state: California
city: Palo Alto
country: United States
facility: 1012.56.01043 Boehringer Ingelheim Investigational Site
state: California
city: Rancho Mirage
country: United States
facility: 1012.56.01089 Boehringer Ingelheim Investigational Site
state: California
city: Riverside
country: United States
facility: 1012.56.01021 Boehringer Ingelheim Investigational Site
state: California
city: San Jose
country: United States
facility: 1012.56.01033 Boehringer Ingelheim Investigational Site
state: California
city: Sepulveda
country: United States
facility: 1012.56.01020 Boehringer Ingelheim Investigational Site
state: California
city: Torrence
country: United States
facility: 1012.56.01045 Boehringer Ingelheim Investigational Site
state: California
city: Denver
country: United States
facility: 1012.56.01040 Boehringer Ingelheim Investigational Site
state: Colorado
city: Fort Collins
country: United States
facility: 1012.56.01050 Boehringer Ingelheim Investigational Site
state: Colorado
city: Wheat Ridge
country: United States
facility: 1012.56.01018 Boehringer Ingelheim Investigational Site
state: Colorado
city: Wheat Ridge
country: United States
facility: 1012.56.01062 Boehringer Ingelheim Investigational Site
state: Colorado
city: Hartford
country: United States
facility: 1012.56.01036 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Stamford
country: United States
facility: 1012.56.01025 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Waterbury
country: United States
facility: 1012.56.01088 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Bay Pines
country: United States
facility: 1012.56.01007 Boehringer Ingelheim Investigational Site
state: Florida
city: Brandon
country: United States
facility: 1012.56.01058 Boehringer Ingelheim Investigational Site
state: Florida
city: Clearwater
country: United States
facility: 1012.56.01010 Boehringer Ingelheim Investigational Site
state: Florida
city: Clearwater
country: United States
facility: 1012.56.01065 Boehringer Ingelheim Investigational Site
state: Florida
city: Deland
country: United States
facility: 1012.56.01024 Boehringer Ingelheim Investigational Site
state: Florida
city: Melbourne
country: United States
facility: 1012.56.01001 Boehringer Ingelheim Investigational Site
state: Florida
city: Panama City
country: United States
facility: 1012.56.01023 Boehringer Ingelheim Investigational Site
state: Florida
city: Pensecola
country: United States
facility: 1012.56.01052 Boehringer Ingelheim Investigational Site
state: Florida
city: Tampa
country: United States
facility: 1012.56.01048 Boehringer Ingelheim Investigational Site
state: Florida
city: Winter Park
country: United States
facility: 1012.56.01093 Boehringer Ingelheim Investigational Site
state: Florida
city: Atlanta
country: United States
facility: 1012.56.01077 Boehringer Ingelheim Investigational Site
state: Georgia
city: Decatur
country: United States
facility: 1012.56.01083 Boehringer Ingelheim Investigational Site
state: Georgia
city: Coeur D'Alene
country: United States
facility: 1012.56.01008 Boehringer Ingelheim Investigational Site
state: Idaho
city: Olathe
country: United States
facility: 1012.56.01019 Boehringer Ingelheim Investigational Site
state: Kansas
city: Wichita
country: United States
facility: 1012.56.01056 Boehringer Ingelheim Investigational Site
state: Kansas
city: Bowling Green
country: United States
facility: 1012.56.01066 Boehringer Ingelheim Investigational Site
state: Kentucky
city: Lafayette
country: United States
facility: 1012.56.01090 Boehringer Ingelheim Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: 1012.56.01054 Boehringer Ingelheim Investigational Site
state: Louisiana
city: New Orleans
country: United States
facility: 1012.56.01072 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: 1012.56.01070 Boehringer Ingelheim Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: 1012.56.01035 Boehringer Ingelheim Investigational Site
state: Maryland
city: Ann Arbor
country: United States
facility: 1012.56.01079 Boehringer Ingelheim Investigational Site
state: Michigan
city: Minneapolis
country: United States
facility: 1012.56.01044 Boehringer Ingelheim Investigational Site
state: Minnesota
city: St. Louis
country: United States
facility: 1012.56.01076 Boehringer Ingelheim Investigational Site
state: Missouri
city: Henderson
country: United States
facility: 1012.56.01082 Boehringer Ingelheim Investigational Site
state: Nevada
city: Reno
country: United States
facility: 1012.56.01049 Boehringer Ingelheim Investigational Site
state: Nevada
city: Brick
country: United States
facility: 1012.56.01080 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Cherry Hill
country: United States
facility: 1012.56.01027 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Summit
country: United States
facility: 1012.56.01028 Boehringer Ingelheim Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: 1012.56.01069 Boehringer Ingelheim Investigational Site
state: New Mexico
city: Larchmont
country: United States
facility: 1012.56.01022 Boehringer Ingelheim Investigational Site
state: New York
city: New Hyde Park
country: United States
facility: 1012.56.01015 Boehringer Ingelheim Investigational Site
state: New York
city: New York City
country: United States
facility: 1012.56.01068 Boehringer Ingelheim Investigational Site
state: New York
city: Asheville
country: United States
facility: 1012.56.01078 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: 1012.56.01017 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: 1012.56.01042 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Sylvania
country: United States
facility: 1012.56.01034 Boehringer Ingelheim Investigational Site
state: Ohio
city: Toledo
country: United States
facility: 1012.56.01031 Boehringer Ingelheim Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: 1012.56.01038 Boehringer Ingelheim Investigational Site
state: Oklahoma
city: Medford
country: United States
facility: 1012.56.01016 Boehringer Ingelheim Investigational Site
state: Oregon
city: Hershey
country: United States
facility: 1012.56.01067 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: 1012.56.01003 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: 1012.56.01060 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 1012.56.01004 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: East Providence
country: United States
facility: 1012.56.01087 Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Johnston
country: United States
facility: 1012.56.01057 Boehringer Ingelheim Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: 1012.56.01026 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Charleston
country: United States
facility: 1012.56.01037 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: 1012.56.01081 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Greenville
country: United States
facility: 1012.56.01085 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Greer
country: United States
facility: 1012.56.01084 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Spartanburg
country: United States
facility: 1012.56.01011 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: 1012.56.01073 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: 1012.56.01075 Boehringer Ingelheim Investigational Site
state: Tennessee
city: Fort Worth
country: United States
facility: 1012.56.01047 Boehringer Ingelheim Investigational Site
state: Texas
city: Houston
country: United States
facility: 1012.56.01014 Boehringer Ingelheim Investigational Site
state: Texas
city: Killeen
country: United States
facility: 1012.56.01032 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1012.56.01002 Boehringer Ingelheim Investigational Site
state: Texas
city: San Antonio
country: United States
facility: 1012.56.01053 Boehringer Ingelheim Investigational Site
state: Texas
city: Richmond
country: United States
facility: 1012.56.01009 Boehringer Ingelheim Investigational Site
state: Virginia
city: Richmond
country: United States
facility: 1012.56.01013 Boehringer Ingelheim Investigational Site
state: Virginia
city: Roanoke
country: United States
facility: 1012.56.01059 Boehringer Ingelheim Investigational Site
state: Virginia
city: Salem
country: United States
facility: 1012.56.01055 Boehringer Ingelheim Investigational Site
state: Virginia
city: Bellington
country: United States
facility: 1012.56.01063 Boehringer Ingelheim Investigational Site
state: Washington
city: Spokane
country: United States
facility: 1012.56.01005 Boehringer Ingelheim Investigational Site
state: Washington
city: Spokane
country: United States
facility: 1012.56.01064 Boehringer Ingelheim Investigational Site
state: Washington
city: Tacoma
country: United States
facility: 1012.56.01030 Boehringer Ingelheim Investigational Site
state: Washington
city: Morgantown
country: United States
facility: 1012.56.01074 Boehringer Ingelheim Investigational Site
state: West Virginia
city: Capital Federal
country: Argentina
facility: 1012.56.54001 Centro Médico de la Dra. De Salvo
city: Capital Federal
country: Argentina
facility: 1012.56.54002 Boehringer Ingelheim Investigational Site
city: Capital Federal
country: Argentina
facility: 1012.56.54003 Policlínica Bancaria
city: Capital Federal
country: Argentina
facility: 1012.56.54004 Hospital Ramos Mejia
city: Capital Federal
country: Argentina
facility: 1012.56.54010 Instituto Lanari
city: Capital Federal
country: Argentina
facility: 1012.56.54011 Boehringer Ingelheim Investigational Site
city: Capital Federal
country: Argentina
facility: 1012.56.54015 Boehringer Ingelheim Investigational Site
city: La Plata
country: Argentina
facility: 1012.56.54005 Instituto de Diagnóstico Cardiovascular La Plata
city: Lanús
country: Argentina
facility: 1012.56.54012 Boehringer Ingelheim Investigational Site
city: Mar del Plata
country: Argentina
facility: 1012.56.54009 Instituto de Investigaciones Clínicas
city: Mendoza
country: Argentina
facility: 1012.56.54014 Boehringer Ingelheim Investigational Site
city: Monte Grande
country: Argentina
facility: 1012.56.54007 CLINICA PRIVADA de MONTE GRANDE
city: Paraná
country: Argentina
facility: 1012.56.54006 CENTRO PRIVADO de MEDICINA RESPIRATORIA
city: Rosario
country: Argentina
facility: 1012.56.54008 HOSPITAL ITALIANO de ROSARIO
city: San Miguel de Tucumán
country: Argentina
facility: 1012.56.54013 Boehringer Ingelheim Investigational Site
city: Béthune
country: France
facility: 1012.56.3305A Centre hospitalier Germon & Gauthier
city: Lille Cedex
country: France
facility: 1012.56.3303A Clinique de la Louvière
city: Marseille
country: France
facility: 1012.56.3301A Hôpital Ambroise Paré
city: Nantes
country: France
facility: 1012.56.3304A Centre Médical Erdre Saint Augustin
city: Nice
country: France
facility: 1012.56.3302A Cabinet Médical
city: Nice
country: France
facility: 1012.56.3302B Cabinet Médical
city: Athens
country: Greece
facility: 1012.56.30001 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1012.56.30011 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1012.56.30013 Boehringer Ingelheim Investigational Site
city: Heraklion
country: Greece
facility: 1012.56.30009 Boehringer Ingelheim Investigational Site
city: Komotini
country: Greece
facility: 1012.56.30007 Boehringer Ingelheim Investigational Site
city: Korinthos
country: Greece
facility: 1012.56.30010 Boehringer Ingelheim Investigational Site
city: Larissa
country: Greece
facility: 1012.56.30002 Boehringer Ingelheim Investigational Site
city: Nafplio
country: Greece
facility: 1012.56.30014 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 1012.56.30003 Boehringer Ingelheim Investigational Site
city: Daegu
country: Korea, Republic of
facility: 1012.56.82009 Boehringer Ingelheim Investigational Site
city: Geonggi-Do
country: Korea, Republic of
facility: 1012.56.82010 Boehringer Ingelheim Investigational Site
city: Gyeonggi-Do
country: Korea, Republic of
facility: 1012.56.82008 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1012.56.82001 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1012.56.82002 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1012.56.82005 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1012.56.82006 Boehringer Ingelheim Investigational Site
city: Seoul
country: Korea, Republic of
facility: 1012.56.82007 Boehringer Ingelheim Investigational Site
city: Dunedin
country: New Zealand
facility: 1012.56.64004 Boehringer Ingelheim Investigational Site
city: Grafton / Auckland
country: New Zealand
facility: 1012.56.64001 Boehringer Ingelheim Investigational Site
city: Hamilton
country: New Zealand
facility: 1012.56.64003 Boehringer Ingelheim Investigational Site
city: Tauranga
country: New Zealand
facility: 1012.56.64006 Boehringer Ingelheim Investigational Site
city: Wellington
country: New Zealand
facility: 1012.56.64005 Boehringer Ingelheim Investigational Site
city: Bydgoszcz
country: Poland
facility: 1012.56.48009 Boehringer Ingelheim Investigational Site
city: Krakow
country: Poland
facility: 1012.56.48006 Boehringer Ingelheim Investigational Site
city: Krakow
country: Poland
facility: 1012.56.48007 Boehringer Ingelheim Investigational Site
city: Ostrow Wielkopolska
country: Poland
facility: 1012.56.48004 Boehringer Ingelheim Investigational Site
city: Poznan
country: Poland
facility: 1012.56.48005 Boehringer Ingelheim Investigational Site
city: Proszowice
country: Poland
facility: 1012.56.48002 Boehringer Ingelheim Investigational Site
city: Radom
country: Poland
facility: 1012.56.48010 Boehringer Ingelheim Investigational Site
city: Warsaw
country: Poland
facility: 1012.56.48001 Boehringer Ingelheim Investigational Site
city: Warsaw
country: Poland
facility: 1012.56.48011 Boehringer Ingelheim Investigational Site
city: Wroclaw
country: Poland
facility: 1012.56.48003 Boehringer Ingelheim Investigational Site
city: Kazan
country: Russian Federation
facility: 1012.56.07010 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1012.56.07001 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1012.56.07002 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1012.56.07003 Boehringer Ingelheim Investigational Site
city: Moscow
country: Russian Federation
facility: 1012.56.07005 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1012.56.07007 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1012.56.07008 Boehringer Ingelheim Investigational Site
city: St.Petersburg
country: Russian Federation
facility: 1012.56.07009 Boehringer Ingelheim Investigational Site
city: Bellville
country: South Africa
facility: 1012.56.27002 Boehringer Ingelheim Investigational Site
city: Boksburg
country: South Africa
facility: 1012.56.27008 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1012.56.27001 Boehringer Ingelheim Investigational Site
city: Cape Town
country: South Africa
facility: 1012.56.27004 Boehringer Ingelheim Investigational Site
city: Johannesburg
country: South Africa
facility: 1012.56.27005 Boehringer Ingelheim Investigational Site
city: Orange Grove
country: South Africa
facility: 1012.56.27009 Boehringer Ingelheim Investigational Site
city: Paarl
country: South Africa
facility: 1012.56.27003 Boehringer Ingelheim Investigational Site
city: Park Town West
country: South Africa
facility: 1012.56.27006 Boehringer Ingelheim Investigational Site
city: Keelong Town
country: Taiwan
facility: 1012.56.88604 Chang Gong Memorial Hospital
city: Taichung
country: Taiwan
facility: 1012.56.88605 Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: 1012.56.88602 Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: 1012.56.88603 National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: 1012.56.88601 Chang Gung Memorial Hosp-Linkou
city: Ankara
country: Turkey
facility: 1012.56.90001 Boehringer Ingelheim Investigational Site
city: Antalya
country: Turkey
facility: 1012.56.90005 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1012.56.90003 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1012.56.90006 Boehringer Ingelheim Investigational Site
city: Mersin
country: Turkey
facility: 1012.56.90002 Boehringer Ingelheim Investigational Site
city: Dnyepropyetrovsk
country: Ukraine
facility: 1012.56.38005 Boehringer Ingelheim Investigational Site
city: Donetsk
country: Ukraine
facility: 1012.56.38006 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1012.56.38001 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1012.56.38002 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1012.56.38004 Boehringer Ingelheim Investigational Site
city: Ballieston, Glasgow
country: United Kingdom
facility: 1012.56.44009 Boehringer Ingelheim Investigational Site
city: Bury St Edmonds
country: United Kingdom
facility: 1012.56.44003 Boehringer Ingelheim Investigational Site
city: Cambridge
country: United Kingdom
facility: 1012.56.44002 Boehringer Ingelheim Investigational Site
city: Colchester
country: United Kingdom
facility: 1012.56.44006 Colchester General Hospital
city: Doncaster
country: United Kingdom
facility: 1012.56.44007 Boehringer Ingelheim Investigational Site
city: Manchester
country: United Kingdom
facility: 1012.56.44001 Medicine Evaluation Unit
city: Soham
country: United Kingdom
facility: 1012.56.44008 The Staploe Medical Centre
city: Swansea
country: United Kingdom
facility: 1012.56.44005 Morriston Hospital
city: Windsor
country: United Kingdom
facility: 1012.56.44010 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Zuwallack R, De Salvo MC, Kaelin T, Bateman ED, Park CS, Abrahams R, Fakih F, Sachs P, Pudi K, Zhao Y, Wood CC; Combivent Respimat Inhaler Study Group. Efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler versus MDI. Respir Med. 2010 Aug;104(8):1179-88. doi: 10.1016/j.rmed.2010.01.017. Epub 2010 Feb 20.