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Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)
This study has been completed.
First Received: November 15, 2006   Last Updated: July 13, 2009   History of Changes
Sponsor: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00400153
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
 Drug: Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
Drug: COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
Drug: Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
 Phase III

Study Type: Interventional
Study Design: Treatment
Official Title: Safety and Efficacy of Combivent Respimat in Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)
Drug Information available for: Combivent
U.S. FDA Resources

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Primary Outcome Measures:
  • FEV1 AUC0-6 at Day 85 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 85 ]
  • FEV1 AUC0-4 at Day 85 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 85 ]
  • FEV1 AUC4-6 at Day 85 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 85 ]

Secondary Outcome Measures:
  • FEV1 AUC0-6 at Day 1 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 1 ]
  • FEV1 AUC0-6 at Day 29 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 29 ]
  • FEV1 AUC0-6 at Day 57 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 57 ]
  • FEV1 AUC0-4 at Day 1 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 1 ]
  • FEV1 AUC0-4 at Day 29 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 29 ]
  • FEV1 AUC0-4 at Day 57 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 57 ]
  • FEV1 AUC4-6 at Day 1 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 1 ]
  • FEV1 AUC4-6 at Day 29 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 29 ]
  • FEV1 AUC4-6 at Day 57 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 57 ]
  • Peak FEV1 Response at Day 1 [ Time Frame: Within the first 2-hour post-treatment interval on Day 1 ]
  • Peak FEV1 Response at Day 29 [ Time Frame: Within the first 2-hour post-treatment interval on Day 29 ]
  • Peak FEV1 Response at Day 57 [ Time Frame: Within the first 2-hour post-treatment interval on Day 57 ]
  • Peak FEV1 Response at Day 85 [ Time Frame: Within the first 2-hour post-treatment interval on Day 85 ]
  • Time to Onset of Therapeutic FEV1 Response at Day 1 [ Time Frame: Within the first 2-hour post-treatment interval at Day 1 ]
  • Time to Onset of Therapeutic FEV1 Response at Day 29 [ Time Frame: Within the first 2-hour post-treatment interval at Day 29 ]
  • Time to Onset of Therapeutic FEV1 Response at Day 57 [ Time Frame: Within the first 2-hour post-treatment interval at Day 57 ]
  • Time to Onset of Therapeutic FEV1 Response at Day 85 [ Time Frame: Within the first 2-hour post-treatment interval at Day 85 ]
  • Duration of Therapeutic FEV1 Response at Day 1 [ Time Frame: During the 6-hour observation period after drug administration at Day 1 ]
  • Duration of Therapeutic FEV1 Response at Day 29 [ Time Frame: During the 6-hour observation period after drug administration at Day 29 ]
  • Duration of Therapeutic FEV1 Response at Day 57 [ Time Frame: During the 6-hour observation period after drug administration at Day 57 ]
  • Duration of Therapeutic FEV1 Response at Day 85 [ Time Frame: During the 6-hour observation period after drug administration at Day 85 ]
  • Time to Peak FEV1 Response at Day 1 [ Time Frame: Within the 6-hour post-treatment observation period at Day 1 ]
  • Time to Peak FEV1 Response at Day 29 [ Time Frame: Within the 6-hour post-treatment observation period at Day 29 ]
  • Time to Peak FEV1 Response at Day 57 [ Time Frame: Within the 6-hour post-treatment observation period at Day 57 ]
  • Time to Peak FEV1 Response at Day 85 [ Time Frame: Within the 6-hour post-treatment observation period at Day 85 ]
  • FVC AUC0-6 at Day 1 [ Time Frame: Before drug administration to 6 hours after drug administration at Day 1 ]
  • FVC AUC0-6 at Day 29 [ Time Frame: Before drug administration to 6 hours after drug administration at Day 29 ]
  • FVC AUC0-6 at Day 57 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 57 ]
  • FVC AUC0-6 at Day 85 [ Time Frame: Before drug administration to 6 hours after drug administration on Day 85 ]
  • FVC AUC0-4 at Day 1 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 1 ]
  • FVC AUC0-4 at Day 29 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 29 ]
  • FVC AUC0-4 at Day 57 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 57 ]
  • FVC AUC0-4 at Day 85 [ Time Frame: Before drug administration to 4 hours after drug administration on Day 85 ]
  • FVC AUC4-6 at Day 1 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 1 ]
  • FVC AUC4-6 at Day 29 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 29 ]
  • FVC AUC4-6 at Day 57 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 57 ]
  • FVC AUC4-6 at Day 85 [ Time Frame: Between 4 hours and 6 hours after drug administration on Day 85 ]
  • Peak FVC Response at Day 1 [ Time Frame: Within the first 2-hour post-treatment interval at Day 1 ]
  • Peak FVC Response at Day 29 [ Time Frame: Within the first 2-hour post-treatment interval at Day 29 ]
  • Peak FVC Response at Day 57 [ Time Frame: Within the first 2-hour post-treatment interval at Day 57 ]
  • Peak FVC Response at Day 85 [ Time Frame: Within the first 2-hour post-treatment interval at Day 85 ]
  • Rescue Medication Use on Pulmonary Test Day 1 [ Time Frame: During the 6-hour pulmonary function testing after drug administration on Day 1 ]
  • Rescue Medication Use on Pulmonary Test Day 29 [ Time Frame: During the 6-hour pulmonary function testing after drug administration on Day 29 ]
  • Rescue Medication Use on Pulmonary Test Day 57 [ Time Frame: During the 6-hour pulmonary function testing after drug administration on Day 57 ]
  • Rescue Medication Use on Pulmonary Test Day 85 [ Time Frame: During the 6-hour pulmonary function testing after drug administration on Day 85 ]
  • Night-time Rescue Medication Use [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period ]
  • Daytime Rescue Medication Use [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period ]
  • Night-time Symptom Score [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period ]
  • Daytime Symptom Score [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period ]
  • Trough Peak Expiratory Flow Rate (PEFR) [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication ]
  • Trough PEFR [ Time Frame: During the 2-week baseline washout period and the 12-week treatment period and PEFR taken before administration of study medication ]
  • Physician's Global Evaluation Score on Pulmonary Function Testing Day 29 [ Time Frame: Prior to pulmonary function test on Day 29 ]
  • Physician's Global Evaluation Score on Pulmonary Function Testing Day 57 [ Time Frame: Prior to pulmonary function test on Day 57 ]
  • Physician's Global Evaluation Score on Pulmonary Function Testing Day 85 [ Time Frame: Prior to pulmonary function test on Day 85 ]
  • Chronic Obstructive Pulmonary Disease (COPD) Excerbation During the On-treatment Period [ Time Frame: During the 12-week on-treatment period ]
  • COPD Excerbation During the On-treatment Period [ Time Frame: During the 12-week on-treatment period ]

Enrollment: 1480
Study Start Date: November 2006
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
COMBIVENT Respimat 20/100 mcg: Experimental Drug: Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
COMBIVENT CFC-MDI 36/206 mcg: Experimental Drug: COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
Ipratropium Respimat 20 mcg: Experimental Drug: Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400153

  Hide Study Locations
Locations
United States, Alabama
1012.56.01006 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
1012.56.01051 Boehringer Ingelheim Investigational Site
Jasper, Alabama, United States
1012.56.01071 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
United States, Arizona
1012.56.01039 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
United States, California
1012.56.01012 Boehringer Ingelheim Investigational Site
Lakewood, California, United States
1012.56.01029 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
1012.56.01043 Boehringer Ingelheim Investigational Site
Palo Alto, California, United States
1012.56.01033 Boehringer Ingelheim Investigational Site
San Jose, California, United States
1012.56.01045 Boehringer Ingelheim Investigational Site
Torrence, California, United States
1012.56.01021 Boehringer Ingelheim Investigational Site
Riverside, California, United States
1012.56.01020 Boehringer Ingelheim Investigational Site
Sepulveda, California, United States
1012.56.01089 Boehringer Ingelheim Investigational Site
Rancho Mirage, California, United States
United States, Colorado
1012.56.01018 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
1012.56.01050 Boehringer Ingelheim Investigational Site
Fort Collins, Colorado, United States
1012.56.01040 Boehringer Ingelheim Investigational Site
Denver, Colorado, United States
1012.56.01062 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
United States, Connecticut
1012.56.01025 Boehringer Ingelheim Investigational Site
Stamford, Connecticut, United States
1012.56.01036 Boehringer Ingelheim Investigational Site
Hartford, Connecticut, United States
1012.56.01088 Boehringer Ingelheim Investigational Site
Waterbury, Connecticut, United States
United States, Florida
1012.56.01001 Boehringer Ingelheim Investigational Site
Melbourne, Florida, United States
1012.56.01007 Boehringer Ingelheim Investigational Site
Bay Pines, Florida, United States
1012.56.01023 Boehringer Ingelheim Investigational Site
Panama City, Florida, United States
1012.56.01024 Boehringer Ingelheim Investigational Site
Deland, Florida, United States
1012.56.01010 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
1012.56.01048 Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
1012.56.01058 Boehringer Ingelheim Investigational Site
Brandon, Florida, United States
1012.56.01052 Boehringer Ingelheim Investigational Site
Pensecola, Florida, United States
1012.56.01065 Boehringer Ingelheim Investigational Site
Clearwater, Florida, United States
1012.56.01093 Boehringer Ingelheim Investigational Site
Winter Park, Florida, United States
United States, Georgia
1012.56.01077 Boehringer Ingelheim Investigational Site
Atlanta, Georgia, United States
1012.56.01083 Boehringer Ingelheim Investigational Site
Decatur, Georgia, United States
United States, Idaho
1012.56.01008 Boehringer Ingelheim Investigational Site
Coeur D'Alene, Idaho, United States
United States, Kansas
1012.56.01019 Boehringer Ingelheim Investigational Site
Olathe, Kansas, United States
1012.56.01056 Boehringer Ingelheim Investigational Site
Wichita, Kansas, United States
United States, Kentucky
1012.56.01066 Boehringer Ingelheim Investigational Site
Bowling Green, Kentucky, United States
United States, Louisiana
1012.56.01054 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, United States
1012.56.01070 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana, United States
1012.56.01072 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana, United States
1012.56.01090 Boehringer Ingelheim Investigational Site
Lafayette, Louisiana, United States
United States, Maryland
1012.56.01035 Boehringer Ingelheim Investigational Site
Baltimore, Maryland, United States
United States, Michigan
1012.56.01079 Boehringer Ingelheim Investigational Site
Ann Arbor, Michigan, United States
United States, Minnesota
1012.56.01044 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota, United States
United States, Missouri
1012.56.01076 Boehringer Ingelheim Investigational Site
St. Louis, Missouri, United States
United States, Nevada
1012.56.01049 Boehringer Ingelheim Investigational Site
Reno, Nevada, United States
1012.56.01082 Boehringer Ingelheim Investigational Site
Henderson, Nevada, United States
United States, New Jersey
1012.56.01027 Boehringer Ingelheim Investigational Site
Cherry Hill, New Jersey, United States
1012.56.01028 Boehringer Ingelheim Investigational Site
Summit, New Jersey, United States
1012.56.01080 Boehringer Ingelheim Investigational Site
Brick, New Jersey, United States
United States, New Mexico
1012.56.01069 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico, United States
United States, New York
1012.56.01015 Boehringer Ingelheim Investigational Site
New Hyde Park, New York, United States
1012.56.01022 Boehringer Ingelheim Investigational Site
Larchmont, New York, United States
1012.56.01068 Boehringer Ingelheim Investigational Site
New York City, New York, United States
United States, North Carolina
1012.56.01017 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina, United States
1012.56.01042 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina, United States
1012.56.01078 Boehringer Ingelheim Investigational Site
Asheville, North Carolina, United States
United States, Ohio
1012.56.01031 Boehringer Ingelheim Investigational Site
Toledo, Ohio, United States
1012.56.01034 Boehringer Ingelheim Investigational Site
Sylvania, Ohio, United States
United States, Oklahoma
1012.56.01038 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
United States, Oregon
1012.56.01016 Boehringer Ingelheim Investigational Site
Medford, Oregon, United States
United States, Pennsylvania
1012.56.01003 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
1012.56.01004 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania, United States
1012.56.01060 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
1012.56.01067 Boehringer Ingelheim Investigational Site
Hershey, Pennsylvania, United States
United States, Rhode Island
1012.56.01057 Boehringer Ingelheim Investigational Site
Johnston, Rhode Island, United States
1012.56.01087 Boehringer Ingelheim Investigational Site
East Providence, Rhode Island, United States
United States, South Carolina
1012.56.01011 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
1012.56.01026 Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
1012.56.01037 Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
1012.56.01081 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
1012.56.01084 Boehringer Ingelheim Investigational Site
Greer, South Carolina, United States
1012.56.01085 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
United States, Tennessee
1012.56.01073 Boehringer Ingelheim Investigational Site
Nashville, Tennessee, United States
1012.56.01075 Boehringer Ingelheim Investigational Site
Nashville, Tennessee, United States
United States, Texas
1012.56.01002 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
1012.56.01014 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1012.56.01032 Boehringer Ingelheim Investigational Site
Killeen, Texas, United States
1012.56.01047 Boehringer Ingelheim Investigational Site
Fort Worth, Texas, United States
1012.56.01053 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
United States, Virginia
1012.56.01009 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
1012.56.01013 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
1012.56.01059 Boehringer Ingelheim Investigational Site
Roanoke, Virginia, United States
1012.56.01055 Boehringer Ingelheim Investigational Site
Salem, Virginia, United States
United States, Washington
1012.56.01005 Boehringer Ingelheim Investigational Site
Spokane, Washington, United States
1012.56.01030 Boehringer Ingelheim Investigational Site
Tacoma, Washington, United States
1012.56.01063 Boehringer Ingelheim Investigational Site
Bellington, Washington, United States
1012.56.01064 Boehringer Ingelheim Investigational Site
Spokane, Washington, United States
United States, West Virginia
1012.56.01074 Boehringer Ingelheim Investigational Site
Morgantown, West Virginia, United States
Argentina
1012.56.54001 Centro Médico de la Dra. De Salvo
Capital Federal, Argentina
1012.56.54002 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1012.56.54003 Policlínica Bancaria
Capital Federal, Argentina
1012.56.54004 Hospital Ramos Mejia
Capital Federal, Argentina
1012.56.54005 Instituto de Diagnóstico Cardiovascular La Plata
La Plata, Argentina
1012.56.54006 CENTRO PRIVADO de MEDICINA RESPIRATORIA
Paraná, Argentina
1012.56.54007 CLINICA PRIVADA de MONTE GRANDE
Monte Grande, Argentina
1012.56.54008 HOSPITAL ITALIANO de ROSARIO
Rosario, Argentina
1012.56.54009 Instituto de Investigaciones Clínicas
Mar del Plata, Argentina
1012.56.54014 Boehringer Ingelheim Investigational Site
Mendoza, Argentina
1012.56.54011 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1012.56.54012 Boehringer Ingelheim Investigational Site
Lanús, Argentina
1012.56.54015 Boehringer Ingelheim Investigational Site
Capital Federal, Argentina
1012.56.54013 Boehringer Ingelheim Investigational Site
San Miguel de Tucumán, Argentina
1012.56.54010 Instituto Lanari
Capital Federal, Argentina
France
1012.56.3301A Hôpital Ambroise Paré
Marseille, France
1012.56.3302A Cabinet Médical
Nice, France
1012.56.3302B Cabinet Médical
Nice, France
1012.56.3303A Clinique de la Louvière
Lille Cedex, France
1012.56.3304A Centre Médical Erdre Saint Augustin
Nantes, France
1012.56.3305A Centre hospitalier Germon & Gauthier
Béthune, France
Greece
1012.56.30009 Boehringer Ingelheim Investigational Site
Heraklion, Greece
1012.56.30002 Boehringer Ingelheim Investigational Site
Larissa, Greece
1012.56.30003 Boehringer Ingelheim Investigational Site
Thessaloniki, Greece
1012.56.30007 Boehringer Ingelheim Investigational Site
Komotini, Greece
1012.56.30001 Boehringer Ingelheim Investigational Site
Athens, Greece
1012.56.30010 Boehringer Ingelheim Investigational Site
Korinthos, Greece
1012.56.30011 Boehringer Ingelheim Investigational Site
Athens, Greece
1012.56.30013 Boehringer Ingelheim Investigational Site
Athens, Greece
1012.56.30014 Boehringer Ingelheim Investigational Site
Nafplio, Greece
Korea, Republic of
1012.56.82002 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1012.56.82005 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1012.56.82009 Boehringer Ingelheim Investigational Site
Daegu, Korea, Republic of
1012.56.82007 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1012.56.82001 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1012.56.82008 Boehringer Ingelheim Investigational Site
Gyeonggi-Do, Korea, Republic of
1012.56.82006 Boehringer Ingelheim Investigational Site
Seoul, Korea, Republic of
1012.56.82010 Boehringer Ingelheim Investigational Site
Geonggi-Do, Korea, Republic of
New Zealand
1012.56.64001 Boehringer Ingelheim Investigational Site
Grafton / Auckland, New Zealand
1012.56.64003 Boehringer Ingelheim Investigational Site
Hamilton, New Zealand
1012.56.64004 Boehringer Ingelheim Investigational Site
Dunedin, New Zealand
1012.56.64005 Boehringer Ingelheim Investigational Site
Wellington, New Zealand
1012.56.64006 Boehringer Ingelheim Investigational Site
Tauranga, New Zealand
Poland
1012.56.48005 Boehringer Ingelheim Investigational Site
Poznan, Poland
1012.56.48002 Boehringer Ingelheim Investigational Site
Proszowice, Poland
1012.56.48003 Boehringer Ingelheim Investigational Site
Wroclaw, Poland
1012.56.48004 Boehringer Ingelheim Investigational Site
Ostrow Wielkopolska, Poland
1012.56.48001 Boehringer Ingelheim Investigational Site
Warsaw, Poland
1012.56.48006 Boehringer Ingelheim Investigational Site
Krakow, Poland
1012.56.48007 Boehringer Ingelheim Investigational Site
Krakow, Poland
1012.56.48009 Boehringer Ingelheim Investigational Site
Bydgoszcz, Poland
1012.56.48010 Boehringer Ingelheim Investigational Site
Radom, Poland
1012.56.48011 Boehringer Ingelheim Investigational Site
Warsaw, Poland
Russian Federation
1012.56.07001 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1012.56.07009 Boehringer Ingelheim Investigational Site
St.Petersburg, Russian Federation
1012.56.07003 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1012.56.07005 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1012.56.07007 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1012.56.07008 Boehringer Ingelheim Investigational Site
St. Petersburg, Russian Federation
1012.56.07002 Boehringer Ingelheim Investigational Site
Moscow, Russian Federation
1012.56.07010 Boehringer Ingelheim Investigational Site
Kazan, Russian Federation
South Africa
1012.56.27001 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1012.56.27002 Boehringer Ingelheim Investigational Site
Bellville, South Africa
1012.56.27003 Boehringer Ingelheim Investigational Site
Paarl, South Africa
1012.56.27004 Boehringer Ingelheim Investigational Site
Cape Town, South Africa
1012.56.27005 Boehringer Ingelheim Investigational Site
Johannesburg, South Africa
1012.56.27006 Boehringer Ingelheim Investigational Site
Park Town West, South Africa
1012.56.27008 Boehringer Ingelheim Investigational Site
Boksburg, South Africa
1012.56.27009 Boehringer Ingelheim Investigational Site
Orange Grove, South Africa
Taiwan
1012.56.88601 Chang Gung Memorial Hosp-Linkou
Taoyuan, Taiwan
1012.56.88602 Taipei Veterans General Hospital
Taipei, Taiwan
1012.56.88603 National Taiwan University Hospital
Taipei, Taiwan
1012.56.88604 Chang Gong Memorial Hospital
Keelong Town, Taiwan
1012.56.88605 Taichung Veterans General Hospital
Taichung, Taiwan
Turkey
1012.56.90001 Boehringer Ingelheim Investigational Site
Ankara, Turkey
1012.56.90002 Boehringer Ingelheim Investigational Site
MERSIN, Turkey
1012.56.90003 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
1012.56.90005 Boehringer Ingelheim Investigational Site
ANTALYA, Turkey
1012.56.90006 Boehringer Ingelheim Investigational Site
Istanbul, Turkey
Ukraine
1012.56.38001 Boehringer Ingelheim Investigational Site
Kiev, Ukraine
1012.56.38002 Boehringer Ingelheim Investigational Site
Kiev, Ukraine
1012.56.38004 Boehringer Ingelheim Investigational Site
Kiev, Ukraine
1012.56.38005 Boehringer Ingelheim Investigational Site
Dnyepropyetrovsk, Ukraine
1012.56.38006 Boehringer Ingelheim Investigational Site
Donetsk, Ukraine
United Kingdom
1012.56.44001 Medicine Evaluation Unit
Manchester, United Kingdom
1012.56.44002 Boehringer Ingelheim Investigational Site
Cambridge, United Kingdom
1012.56.44003 Boehringer Ingelheim Investigational Site
Bury St Edmonds, United Kingdom
1012.56.44005 Morriston Hospital
Swansea, United Kingdom
1012.56.44010 Boehringer Ingelheim Investigational Site
Windsor, United Kingdom
1012.56.44007 Boehringer Ingelheim Investigational Site
Doncaster, United Kingdom
1012.56.44008 The Staploe Medical Centre
Soham, United Kingdom
1012.56.44009 Boehringer Ingelheim Investigational Site
Ballieston, Glasgow, United Kingdom
1012.56.44006 Colchester General Hospital
Colchester, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1012.56
Study First Received: November 15, 2006
Results First Received: April 3, 2009
Last Updated: July 13, 2009
ClinicalTrials.gov Identifier: NCT00400153     History of Changes
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products;   Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow;   Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine);   New Zealand: Multicentre Ethics Committee/Medsafe;   United States: Food and Drug Administration;   France: AFSSAPS;   Greece: National Organization for Medicines (EOF) National Ethics Committee;   Argentina: A.N.M.A.T. (Administración Nacional de Medicamentos, Alimentos y Tecnología);   Taiwan: Department of Health, Executive Yuan, Taiwan;   Korea, Republic of: Korea Food and Drug Administration;   Turkey: Ministry of Health Central Ethics Committee;   Great Britain: MHRA;   South Africa: MCC (Medicines Control Council)

Additional relevant MeSH terms:
Disease Attributes
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases
 Lung Diseases
Respiration Disorders
Chronic Disease
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on November 27, 2009



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