Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)

June 9, 2014 updated by: Boehringer Ingelheim

Safety and Efficacy of Combivent Respimat in Chronic Obstructive Pulmonary Disease (COPD)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1480

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: COMBIVENT Respimat 20/100 mcg
Drug: Combivent Respimat (20 mcg/100 mcg)
Drug: Placebo via corresponding inhaler for blinding purposes
EXPERIMENTAL: COMBIVENT CFC-MDI 36/206 mcg
Drug: Placebo via corresponding inhaler for blinding purposes
Drug: COMBIVENT MDI (36/206 mcg)
EXPERIMENTAL: Ipratropium Respimat 20 mcg
Drug: Placebo via corresponding inhaler for blinding purposes
Drug: Atrovent Respimat (20 mcg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FEV1 AUC0-6 at Day 85
Time Frame: Before drug administration to 6 hours after drug administration on Day 85
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85
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
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85
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
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85
Between 4 hours and 6 hours after drug administration on Day 85

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FEV1 AUC0-6 at Day 1
Time Frame: Before drug administration to 6 hours after drug administration on Day 1
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1
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
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29
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
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57
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
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1
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
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29
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
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57
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
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1
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
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29
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
Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57
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
Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1
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
Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29
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
Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57
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
Maximum change in recorded FEV1 value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85
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
Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 1
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
Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 29
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
Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 57
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
Achievement of recorded FEV1 measurement of at least 1.15 times of the corresponding test-day baseline value at any time during the first 2 hours of observation after drug administration at Day 85
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
The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 1
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
The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 29
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
The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 57
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
The time interval between the onset and the the termination of a therapeutic FEV1 response (at least 1.15 times the corresponding test-day baseline value) during the 6-hour observation period at Day 85
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
The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 1
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
The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 29
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
The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 57
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
The first time point at which the maximum change in recorded FEV1 data from the corresponding test-day baseline occurred during the 6-hours observation period after drug administration at Day 85
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
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 1
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
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 29
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
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 57
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
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85
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
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 1
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
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 29
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
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 57
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
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85
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
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 1
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
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 29
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
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 57
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
Area between the test-day baseline FVC and the FVC change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85
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
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 1
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
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 29
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
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 57
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
Maximum change in recorded FVC value from the corresponding test-day baseline within the first 2 hours after drug administration on Day 85
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
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 1
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
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 29
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
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 57
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
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 85
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
The mean number of puffs of rescue medication used during the night-time per week during the entire study (including baseline and on-treatment period)
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
The mean number of puffs of rescue medication used during the daytime per week during the entire study (including baseline and on-treatment period)
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

The weekly mean night-time symptom score per week during the entire study (including baseline and on-treatment period).

Night-time COPD symptoms: 0=none 1=some - slept well 2=woke once 3=woke several times 4=woke most of night
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

The weekly mean daytime symptom score per week during the entire study (including baseline and on-treatment period).

Daytime COPD symptoms: 0=none 1=occasional 2=frequent, no interference with activities 3=most of day, interference with activities 4=prevent working and activities
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
The weekly mean trough PEFR during the entire study (including baseline and on-treatment period)
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 is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.

Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent.
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 is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.

Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent.
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

Physician's Global Evaluation score is based on the need for concomitant medication, number and severity of exacerbations since the last visit, severity of cough, ability to exercise, amount of wheezing, etc.

Score: 1,2 = poor; 3,4 = fair; 5,6 =good; 7,8 = excellent.
Prior to pulmonary function test on Day 85
Percentage of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the On-treatment Period
Time Frame: During the 12-week on-treatment period
COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.
During the 12-week on-treatment period
COPD Exacerbation Rate During the On-treatment Period
Time Frame: During the 12-week on-treatment period
Proportion of patients experiencing a COPD exacerbation per patient year. COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.
During the 12-week on-treatment period
COPD Exacerbation During the On-treatment Period
Time Frame: During the 12-week on-treatment period
COPD exacerbation is defined as an increase or new onset of more than one of the following respiratory symptoms (cough, sputum, sputum purulence, wheezing, dyspnea, and chest tightness) having a duration of three or more days requiring treatment with an antibiotic and/or systemic steroids with or without hospital admission.
During the 12-week on-treatment period
Frequency Distribution of Satisfaction Rating With Inhaler Attributes
Time Frame: 12 weeks
12 weeks
Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine
Time Frame: 12 weeks

Patients rated their response on a seven point Likert scale:

1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
12 weeks
Mean Rating Scores of Satisfaction With Inhaler - Feeling That the Inhaled Dose Goes to the Lung
Time Frame: 12 weeks

Patients rated their response on a seven point Likert scale:

1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
12 weeks
Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left
Time Frame: 12 weeks

Patients rated their response on a seven point Likert scale:

1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
12 weeks
Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably
Time Frame: 12 weeks

Patients rated their response on a seven point Likert scale:

1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
12 weeks
Mean Rating Scores of Satisfaction With Inhaler - Ease of Inhaling a Dose From the Inhaler
Time Frame: 12 weeks

Patients rated their response on a seven point Likert scale:

1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
12 weeks
Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use
Time Frame: 12 weeks

Patients rated their response on a seven point Likert scale:

1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
12 weeks
Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable
Time Frame: 12 weeks

Patients rated their response on a seven point Likert scale:

1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
12 weeks
Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler
Time Frame: 12 weeks

Patients rated their response on a seven point Likert scale:

1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
12 weeks
Mean Rating Scores of Satisfaction With Inhaler - Speed of Medicine Coming Out of the Inhaler
Time Frame: 12 weeks

Patients rated their response on a seven point Likert scale:

1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
12 weeks
Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler
Time Frame: 12 weeks

Patients rated their response on a seven point Likert scale:

1 = very dissatisfied, 2 = dissatisfied, 3 = somewhat dissatisfied, 4 = neither satisfied nor dissatisfied, 5 = somewhat satisfied, 6 = satisfied, 7 = very satisfied.
12 weeks
Device Preference (Respimat or MDI)
Time Frame: 12 weeks
Frequency of patients due to device preference
12 weeks
Rating of Action of Turning Clear Base of Respimat
Time Frame: 12 weeks
Frequency of patients due to rating of action of turning clear base of Respimat
12 weeks
Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State
Time Frame: Before drug administration to 6 hours after drug administration on Day 29
Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose).
Before drug administration to 6 hours after drug administration on Day 29
Noncompartmental Parameters of Albuterol at Steady State
Time Frame: Before drug administration to 6 hours after drug administration on Day 29
Geometric mean area under the plasma drug concentration time curve over one dosing interval (AUCτ). Each patient had eight plasma samples (trough pre-dose, 5, 15, 30, and 60 minutes post-dose, as well as 2, 4, and 6 hours post-dose).
Before drug administration to 6 hours after drug administration on Day 29
Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-2 Hours
Time Frame: Before drug administration to 2 hours after drug administration on Day 29
Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0-2, ss
Before drug administration to 2 hours after drug administration on Day 29
Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-2 Hours
Time Frame: Before drug administration to 2 hours after drug administration on Day 29
Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0-2,ss.
Before drug administration to 2 hours after drug administration on Day 29
Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-6 Hours
Time Frame: Before drug administration to 6 hours after drug administration on Day 26
Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0-6,ss
Before drug administration to 6 hours after drug administration on Day 26
Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-6 Hours
Time Frame: Before drug administration to 6 hours after drug administration on Day 29
Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0-6, ss
Before drug administration to 6 hours after drug administration on Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

November 15, 2006

First Submitted That Met QC Criteria

November 15, 2006

First Posted (ESTIMATE)

November 16, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

June 13, 2014

Last Update Submitted That Met QC Criteria

June 9, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1012.56

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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