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

NCT ID: NCT00400153

Last Updated: 2014-06-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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COMBIVENT Respimat 20/100 mcg

Group Type EXPERIMENTAL

Combivent Respimat (20 mcg/100 mcg)

Intervention Type DRUG

Placebo via corresponding inhaler for blinding purposes

Intervention Type DRUG

COMBIVENT CFC-MDI 36/206 mcg

Group Type EXPERIMENTAL

COMBIVENT MDI (36/206 mcg)

Intervention Type DRUG

Placebo via corresponding inhaler for blinding purposes

Intervention Type DRUG

Ipratropium Respimat 20 mcg

Group Type EXPERIMENTAL

Atrovent Respimat (20 mcg)

Intervention Type DRUG

Placebo via corresponding inhaler for blinding purposes

Intervention Type DRUG

Interventions

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Atrovent Respimat (20 mcg)

Intervention Type DRUG

COMBIVENT MDI (36/206 mcg)

Intervention Type DRUG

Combivent Respimat (20 mcg/100 mcg)

Intervention Type DRUG

Placebo via corresponding inhaler for blinding purposes

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Boehringer Ingelheim

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1012.56.01006 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Site Status

1012.56.01051 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

Site Status

1012.56.01071 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Site Status

1012.56.01039 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

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1012.56.01012 Boehringer Ingelheim Investigational Site

Lakewood, California, United States

Site Status

1012.56.01029 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Site Status

1012.56.01043 Boehringer Ingelheim Investigational Site

Palo Alto, California, United States

Site Status

1012.56.01089 Boehringer Ingelheim Investigational Site

Rancho Mirage, California, United States

Site Status

1012.56.01021 Boehringer Ingelheim Investigational Site

Riverside, California, United States

Site Status

1012.56.01033 Boehringer Ingelheim Investigational Site

San Jose, California, United States

Site Status

1012.56.01020 Boehringer Ingelheim Investigational Site

Sepulveda, California, United States

Site Status

1012.56.01045 Boehringer Ingelheim Investigational Site

Torrence, California, United States

Site Status

1012.56.01040 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Site Status

1012.56.01050 Boehringer Ingelheim Investigational Site

Fort Collins, Colorado, United States

Site Status

1012.56.01018 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Site Status

1012.56.01062 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Site Status

1012.56.01036 Boehringer Ingelheim Investigational Site

Hartford, Connecticut, United States

Site Status

1012.56.01025 Boehringer Ingelheim Investigational Site

Stamford, Connecticut, United States

Site Status

1012.56.01088 Boehringer Ingelheim Investigational Site

Waterbury, Connecticut, United States

Site Status

1012.56.01007 Boehringer Ingelheim Investigational Site

Bay Pines, Florida, United States

Site Status

1012.56.01058 Boehringer Ingelheim Investigational Site

Brandon, Florida, United States

Site Status

1012.56.01010 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Site Status

1012.56.01065 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

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1012.56.01024 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Site Status

1012.56.01001 Boehringer Ingelheim Investigational Site

Melbourne, Florida, United States

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1012.56.01023 Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

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1012.56.01052 Boehringer Ingelheim Investigational Site

Pensecola, Florida, United States

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1012.56.01048 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

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1012.56.01093 Boehringer Ingelheim Investigational Site

Winter Park, Florida, United States

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1012.56.01077 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

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1012.56.01083 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

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1012.56.01008 Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, United States

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1012.56.01019 Boehringer Ingelheim Investigational Site

Olathe, Kansas, United States

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1012.56.01056 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

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1012.56.01066 Boehringer Ingelheim Investigational Site

Bowling Green, Kentucky, United States

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1012.56.01090 Boehringer Ingelheim Investigational Site

Lafayette, Louisiana, United States

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1012.56.01054 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

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1012.56.01072 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

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1012.56.01070 Boehringer Ingelheim Investigational Site

Shreveport, Louisiana, United States

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1012.56.01035 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

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1012.56.01079 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

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1012.56.01044 Boehringer Ingelheim Investigational Site

Minneapolis, Minnesota, United States

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1012.56.01076 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

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1012.56.01082 Boehringer Ingelheim Investigational Site

Henderson, Nevada, United States

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1012.56.01049 Boehringer Ingelheim Investigational Site

Reno, Nevada, United States

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1012.56.01080 Boehringer Ingelheim Investigational Site

Brick, New Jersey, United States

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1012.56.01027 Boehringer Ingelheim Investigational Site

Cherry Hill, New Jersey, United States

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1012.56.01028 Boehringer Ingelheim Investigational Site

Summit, New Jersey, United States

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1012.56.01069 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

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1012.56.01022 Boehringer Ingelheim Investigational Site

Larchmont, New York, United States

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1012.56.01015 Boehringer Ingelheim Investigational Site

New Hyde Park, New York, United States

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1012.56.01068 Boehringer Ingelheim Investigational Site

New York, New York, United States

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1012.56.01078 Boehringer Ingelheim Investigational Site

Asheville, North Carolina, United States

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1012.56.01017 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

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1012.56.01042 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

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1012.56.01034 Boehringer Ingelheim Investigational Site

Sylvania, Ohio, United States

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1012.56.01031 Boehringer Ingelheim Investigational Site

Toledo, Ohio, United States

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1012.56.01038 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

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1012.56.01016 Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

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1012.56.01067 Boehringer Ingelheim Investigational Site

Hershey, Pennsylvania, United States

Site Status

1012.56.01003 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

1012.56.01060 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

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1012.56.01004 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

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1012.56.01087 Boehringer Ingelheim Investigational Site

East Providence, Rhode Island, United States

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1012.56.01057 Boehringer Ingelheim Investigational Site

Johnston, Rhode Island, United States

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1012.56.01026 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

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1012.56.01037 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

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1012.56.01081 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

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1012.56.01085 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

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1012.56.01084 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

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1012.56.01011 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

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1012.56.01073 Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

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1012.56.01075 Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

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1012.56.01047 Boehringer Ingelheim Investigational Site

Fort Worth, Texas, United States

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1012.56.01014 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

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1012.56.01032 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

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1012.56.01002 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

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1012.56.01053 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

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1012.56.01009 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

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1012.56.01013 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

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1012.56.01059 Boehringer Ingelheim Investigational Site

Roanoke, Virginia, United States

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1012.56.01055 Boehringer Ingelheim Investigational Site

Salem, Virginia, United States

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1012.56.01063 Boehringer Ingelheim Investigational Site

Bellington, Washington, United States

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1012.56.01005 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

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1012.56.01064 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

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1012.56.01030 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

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1012.56.01074 Boehringer Ingelheim Investigational Site

Morgantown, West Virginia, United States

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1012.56.54001 Centro Médico de la Dra. De Salvo

Capital Federal, , Argentina

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1012.56.54002 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

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1012.56.54003 Policlínica Bancaria

Capital Federal, , Argentina

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1012.56.54004 Hospital Ramos Mejia

Capital Federal, , Argentina

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1012.56.54010 Instituto Lanari

Capital Federal, , Argentina

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1012.56.54011 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

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1012.56.54015 Boehringer Ingelheim Investigational Site

Capital Federal, , Argentina

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1012.56.54005 Instituto de Diagnóstico Cardiovascular La Plata

La Plata, , Argentina

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1012.56.54012 Boehringer Ingelheim Investigational Site

Lanús, , Argentina

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1012.56.54009 Instituto de Investigaciones Clínicas

Mar del Plata, , Argentina

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1012.56.54014 Boehringer Ingelheim Investigational Site

Mendoza, , Argentina

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1012.56.54007 CLINICA PRIVADA de MONTE GRANDE

Monte Grande, , Argentina

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1012.56.54006 CENTRO PRIVADO de MEDICINA RESPIRATORIA

Paraná, , Argentina

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1012.56.54008 HOSPITAL ITALIANO de ROSARIO

Rosario, , Argentina

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1012.56.54013 Boehringer Ingelheim Investigational Site

San Miguel de Tucumán, , Argentina

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1012.56.3305A Centre hospitalier Germon & Gauthier

Béthune, , France

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1012.56.3303A Clinique de la Louvière

Lille, , France

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1012.56.3301A Hôpital Ambroise Paré

Marseille, , France

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1012.56.3304A Centre Médical Erdre Saint Augustin

Nantes, , France

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1012.56.3302A Cabinet Médical

Nice, , France

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1012.56.3302B Cabinet Médical

Nice, , France

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1012.56.30001 Boehringer Ingelheim Investigational Site

Athens, , Greece

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1012.56.30011 Boehringer Ingelheim Investigational Site

Athens, , Greece

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1012.56.30013 Boehringer Ingelheim Investigational Site

Athens, , Greece

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1012.56.30010 Boehringer Ingelheim Investigational Site

Corinth, , Greece

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1012.56.30009 Boehringer Ingelheim Investigational Site

Heraklion, , Greece

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1012.56.30007 Boehringer Ingelheim Investigational Site

Komotini, , Greece

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1012.56.30002 Boehringer Ingelheim Investigational Site

Larissa, , Greece

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1012.56.30014 Boehringer Ingelheim Investigational Site

Nafplion, , Greece

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1012.56.30003 Boehringer Ingelheim Investigational Site

Thessaloniki, , Greece

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1012.56.64004 Boehringer Ingelheim Investigational Site

Dunedin, , New Zealand

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1012.56.64001 Boehringer Ingelheim Investigational Site

Grafton / Auckland, , New Zealand

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1012.56.64003 Boehringer Ingelheim Investigational Site

Hamilton, , New Zealand

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1012.56.64006 Boehringer Ingelheim Investigational Site

Tauranga, , New Zealand

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1012.56.64005 Boehringer Ingelheim Investigational Site

Wellington, , New Zealand

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1012.56.48009 Boehringer Ingelheim Investigational Site

Bydgoszcz, , Poland

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1012.56.48006 Boehringer Ingelheim Investigational Site

Krakow, , Poland

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1012.56.48007 Boehringer Ingelheim Investigational Site

Krakow, , Poland

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1012.56.48004 Boehringer Ingelheim Investigational Site

Ostrow Wielkopolska, , Poland

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1012.56.48005 Boehringer Ingelheim Investigational Site

Poznan, , Poland

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1012.56.48002 Boehringer Ingelheim Investigational Site

Proszowice, , Poland

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1012.56.48010 Boehringer Ingelheim Investigational Site

Radom, , Poland

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1012.56.48001 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

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1012.56.48011 Boehringer Ingelheim Investigational Site

Warsaw, , Poland

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1012.56.48003 Boehringer Ingelheim Investigational Site

Wroclaw, , Poland

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1012.56.07010 Boehringer Ingelheim Investigational Site

Kazan', , Russia

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1012.56.07001 Boehringer Ingelheim Investigational Site

Moscow, , Russia

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1012.56.07002 Boehringer Ingelheim Investigational Site

Moscow, , Russia

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1012.56.07003 Boehringer Ingelheim Investigational Site

Moscow, , Russia

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1012.56.07005 Boehringer Ingelheim Investigational Site

Moscow, , Russia

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1012.56.07007 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

Site Status

1012.56.07008 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

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1012.56.07009 Boehringer Ingelheim Investigational Site

Saint Petersburg, , Russia

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1012.56.27002 Boehringer Ingelheim Investigational Site

Bellville, , South Africa

Site Status

1012.56.27008 Boehringer Ingelheim Investigational Site

Boksburg, , South Africa

Site Status

1012.56.27001 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

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1012.56.27004 Boehringer Ingelheim Investigational Site

Cape Town, , South Africa

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1012.56.27005 Boehringer Ingelheim Investigational Site

Johannesburg, , South Africa

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1012.56.27009 Boehringer Ingelheim Investigational Site

Orange Grove, , South Africa

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1012.56.27003 Boehringer Ingelheim Investigational Site

Paarl, , South Africa

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1012.56.27006 Boehringer Ingelheim Investigational Site

Park Town West, , South Africa

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1012.56.82009 Boehringer Ingelheim Investigational Site

Daegu, , South Korea

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1012.56.82010 Boehringer Ingelheim Investigational Site

Geonggi-Do, , South Korea

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1012.56.82008 Boehringer Ingelheim Investigational Site

Gyeonggi-do, , South Korea

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1012.56.82001 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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1012.56.82002 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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1012.56.82005 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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1012.56.82006 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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1012.56.82007 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

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1012.56.88604 Chang Gong Memorial Hospital

Keelong Town, , Taiwan

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1012.56.88605 Taichung Veterans General Hospital

Taichung, , Taiwan

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1012.56.88602 Taipei Veterans General Hospital

Taipei, , Taiwan

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1012.56.88603 National Taiwan University Hospital

Taipei, , Taiwan

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1012.56.88601 Chang Gung Memorial Hosp-Linkou

Taoyuan District, , Taiwan

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1012.56.90001 Boehringer Ingelheim Investigational Site

Ankara, , Turkey (Türkiye)

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1012.56.90005 Boehringer Ingelheim Investigational Site

Antalya, , Turkey (Türkiye)

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1012.56.90003 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

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1012.56.90006 Boehringer Ingelheim Investigational Site

Istanbul, , Turkey (Türkiye)

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1012.56.90002 Boehringer Ingelheim Investigational Site

Mersin, , Turkey (Türkiye)

Site Status

1012.56.38005 Boehringer Ingelheim Investigational Site

Dnyepropyetrovsk, , Ukraine

Site Status

1012.56.38006 Boehringer Ingelheim Investigational Site

Donetsk, , Ukraine

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1012.56.38001 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

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1012.56.38002 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

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1012.56.38004 Boehringer Ingelheim Investigational Site

Kiev, , Ukraine

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1012.56.44009 Boehringer Ingelheim Investigational Site

Ballieston, Glasgow, , United Kingdom

Site Status

1012.56.44003 Boehringer Ingelheim Investigational Site

Bury Saint Edmonds, , United Kingdom

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1012.56.44002 Boehringer Ingelheim Investigational Site

Cambridge, , United Kingdom

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1012.56.44006 Colchester General Hospital

Colchester, , United Kingdom

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1012.56.44007 Boehringer Ingelheim Investigational Site

Doncaster, , United Kingdom

Site Status

1012.56.44001 Medicine Evaluation Unit

Manchester, , United Kingdom

Site Status

1012.56.44008 The Staploe Medical Centre

Soham, , United Kingdom

Site Status

1012.56.44005 Morriston Hospital

Swansea, , United Kingdom

Site Status

1012.56.44010 Boehringer Ingelheim Investigational Site

Windsor, , United Kingdom

Site Status

Countries

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United States Argentina France Greece New Zealand Poland Russia South Africa South Korea Taiwan Turkey (Türkiye) Ukraine United Kingdom

References

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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.

Reference Type DERIVED
PMID: 20172704 (View on PubMed)

Other Identifiers

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1012.56

Identifier Type: -

Identifier Source: org_study_id

NCT00847652

Identifier Type: -

Identifier Source: nct_alias

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Efficacy and Tolerability Study in Severe Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT01415518 COMPLETED PHASE4
Combivent® HFA-propelled Compared to CFC-propelled Metered Dose Inhaler in Patients With COPD (Chronic Obstructive Pulmonary Disease)
NCT02182869 TERMINATED PHASE2
Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD)
NCT03197818 COMPLETED PHASE3
Comparison of Safety and Efficacy of COMBIVENT HFA to COMBIVENT (CFC) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT02194205 TERMINATED PHASE3
A Comparison of Symbicort® pMDI 2 x 160/4.5 μg Bid and 2 x 80/4.5 μg Bid With Formoterol Turbuhaler® 2 x 4.5 μg Bid and Placebo in Patients With COPD
NCT00206167 COMPLETED PHASE3
A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD
NCT00419744 COMPLETED PHASE3
Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD
NCT04446637 WITHDRAWN PHASE3
Efficacy and Safety of Tiotropium and Atrovent in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT02172469 COMPLETED PHASE3
Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Patients With COPD.
NCT00452400 COMPLETED PHASE2
Study to Assess the Safety of Ipratropium Bromide, in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT02236182 COMPLETED PHASE2