Pulmonary Disease, Chronic ObstructivePhase 3NCT00400153
Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Atrovent Respimat (20 mcg), COMBIVENT MDI (36/206 mcg) and Combivent Respimat (20 mcg/100 mcg) in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 180 sites in 13 countries.
Trial summary
The primary objective of this study is to compare the effect of ipratropium bromide/salbutamol inhalation spray combination administered by the Respimat® inhaler (20 mcg/100 mcg), ipratropium bromide inhalation spray administered by the Respimat® inhaler (20 mcg), and COMBIVENT® MDI administered q.i.d on FEV1 at… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Atrovent Respimat (20 mcg), COMBIVENT MDI (36/206 mcg) and Combivent Respimat (20 mcg/100 mcg)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,480 participants
- Where
- 180 sitesin 13 countries
- Study dates
- Nov 2006to Apr 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients of either sex, 40 years or older, with a diagnosis of COPD (FEV1 65% predicted normal and FEV1/FVC 70%).
Who cannot join
- 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.
Trial locations and contacts
180 sites in 13 countries.
180 sites in 13 countries
United States87 sites
1012.56.01069 Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico
1012.56.01079 Boehringer Ingelheim Investigational Site
Ann Arbor, Michigan
1012.56.01078 Boehringer Ingelheim Investigational Site
Asheville, North Carolina
1012.56.01077 Boehringer Ingelheim Investigational Site
Atlanta, Georgia
1012.56.01035 Boehringer Ingelheim Investigational Site
Baltimore, Maryland
1012.56.01007 Boehringer Ingelheim Investigational Site
Bay Pines, Florida
1012.56.01063 Boehringer Ingelheim Investigational Site
Bellington, Washington
1012.56.01006 Boehringer Ingelheim Investigational Site
Birmingham, Alabama
1012.56.01066 Boehringer Ingelheim Investigational Site
Bowling Green, Kentucky
1012.56.01058 Boehringer Ingelheim Investigational Site
Brandon, Florida
1012.56.01080 Boehringer Ingelheim Investigational Site
Brick, New Jersey
1012.56.01026 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
1012.56.01037 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
1012.56.01027 Boehringer Ingelheim Investigational Site
Cherry Hill, New Jersey
1012.56.01010 Boehringer Ingelheim Investigational Site
Clearwater, Florida
1012.56.01065 Boehringer Ingelheim Investigational Site
Clearwater, Florida
1012.56.01008 Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho
1012.56.01083 Boehringer Ingelheim Investigational Site
Decatur, Georgia
1012.56.01024 Boehringer Ingelheim Investigational Site
DeLand, Florida
1012.56.01040 Boehringer Ingelheim Investigational Site
Denver, Colorado
1012.56.01087 Boehringer Ingelheim Investigational Site
East Providence, Rhode Island
1012.56.01050 Boehringer Ingelheim Investigational Site
Fort Collins, Colorado
1012.56.01047 Boehringer Ingelheim Investigational Site
Fort Worth, Texas
1012.56.01081 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
1012.56.01085 Boehringer Ingelheim Investigational Site
Greenville, South Carolina
1012.56.01084 Boehringer Ingelheim Investigational Site
Greer, South Carolina
1012.56.01036 Boehringer Ingelheim Investigational Site
Hartford, Connecticut
1012.56.01082 Boehringer Ingelheim Investigational Site
Henderson, Nevada
1012.56.01067 Boehringer Ingelheim Investigational Site
Hershey, Pennsylvania
1012.56.01014 Boehringer Ingelheim Investigational Site
Houston, Texas
1012.56.01051 Boehringer Ingelheim Investigational Site
Jasper, Alabama
1012.56.01057 Boehringer Ingelheim Investigational Site
Johnston, Rhode Island
1012.56.01032 Boehringer Ingelheim Investigational Site
Killeen, Texas
1012.56.01090 Boehringer Ingelheim Investigational Site
Lafayette, Louisiana
1012.56.01012 Boehringer Ingelheim Investigational Site
Lakewood, California
1012.56.01022 Boehringer Ingelheim Investigational Site
Larchmont, New York
1012.56.01029 Boehringer Ingelheim Investigational Site
Los Angeles, California
1012.56.01016 Boehringer Ingelheim Investigational Site
Medford, Oregon
1012.56.01001 Boehringer Ingelheim Investigational Site
Melbourne, Florida
1012.56.01044 Boehringer Ingelheim Investigational Site
Minneapolis, Minnesota
1012.56.01071 Boehringer Ingelheim Investigational Site
Mobile, Alabama
1012.56.01074 Boehringer Ingelheim Investigational Site
Morgantown, West Virginia
1012.56.01073 Boehringer Ingelheim Investigational Site
Nashville, Tennessee
1012.56.01075 Boehringer Ingelheim Investigational Site
Nashville, Tennessee
1012.56.01015 Boehringer Ingelheim Investigational Site
New Hyde Park, New York
1012.56.01054 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana
1012.56.01072 Boehringer Ingelheim Investigational Site
New Orleans, Louisiana
1012.56.01068 Boehringer Ingelheim Investigational Site
New York, New York
1012.56.01038 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
1012.56.01019 Boehringer Ingelheim Investigational Site
Olathe, Kansas
1012.56.01043 Boehringer Ingelheim Investigational Site
Palo Alto, California
1012.56.01023 Boehringer Ingelheim Investigational Site
Panama City, Florida
1012.56.01052 Boehringer Ingelheim Investigational Site
Pensecola, Florida
1012.56.01003 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1012.56.01060 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania
1012.56.01039 Boehringer Ingelheim Investigational Site
Phoenix, Arizona
1012.56.01004 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
1012.56.01017 Boehringer Ingelheim Investigational Site
Raleigh, North Carolina
1012.56.01089 Boehringer Ingelheim Investigational Site
Rancho Mirage, California
1012.56.01049 Boehringer Ingelheim Investigational Site
Reno, Nevada
1012.56.01009 Boehringer Ingelheim Investigational Site
Richmond, Virginia
1012.56.01013 Boehringer Ingelheim Investigational Site
Richmond, Virginia
1012.56.01021 Boehringer Ingelheim Investigational Site
Riverside, California
1012.56.01059 Boehringer Ingelheim Investigational Site
Roanoke, Virginia
1012.56.01055 Boehringer Ingelheim Investigational Site
Salem, Virginia
1012.56.01002 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1012.56.01053 Boehringer Ingelheim Investigational Site
San Antonio, Texas
1012.56.01033 Boehringer Ingelheim Investigational Site
San Jose, California
1012.56.01020 Boehringer Ingelheim Investigational Site
Sepulveda, California
1012.56.01070 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana
1012.56.01011 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina
1012.56.01005 Boehringer Ingelheim Investigational Site
Spokane, Washington
1012.56.01064 Boehringer Ingelheim Investigational Site
Spokane, Washington
1012.56.01076 Boehringer Ingelheim Investigational Site
St Louis, Missouri
1012.56.01025 Boehringer Ingelheim Investigational Site
Stamford, Connecticut
1012.56.01028 Boehringer Ingelheim Investigational Site
Summit, New Jersey
1012.56.01034 Boehringer Ingelheim Investigational Site
Sylvania, Ohio
1012.56.01030 Boehringer Ingelheim Investigational Site
Tacoma, Washington
1012.56.01048 Boehringer Ingelheim Investigational Site
Tampa, Florida
1012.56.01031 Boehringer Ingelheim Investigational Site
Toledo, Ohio
1012.56.01045 Boehringer Ingelheim Investigational Site
Torrence, California
1012.56.01088 Boehringer Ingelheim Investigational Site
Waterbury, Connecticut
1012.56.01018 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado
1012.56.01062 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado
1012.56.01056 Boehringer Ingelheim Investigational Site
Wichita, Kansas
1012.56.01042 Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina
1012.56.01093 Boehringer Ingelheim Investigational Site
Winter Park, Florida
Argentina15 sites
1012.56.54001 Centro Médico de la Dra. De Salvo
Capital Federal
1012.56.54002 Boehringer Ingelheim Investigational Site
Capital Federal
1012.56.54003 Policlínica Bancaria
Capital Federal
1012.56.54004 Hospital Ramos Mejia
Capital Federal
1012.56.54010 Instituto Lanari
Capital Federal
1012.56.54011 Boehringer Ingelheim Investigational Site
Capital Federal
1012.56.54015 Boehringer Ingelheim Investigational Site
Capital Federal
1012.56.54005 Instituto de Diagnóstico Cardiovascular La Plata
La Plata
1012.56.54012 Boehringer Ingelheim Investigational Site
Lanus
1012.56.54009 Instituto de Investigaciones Clínicas
Mar del Plata
1012.56.54014 Boehringer Ingelheim Investigational Site
Mendoza
1012.56.54007 CLINICA PRIVADA de MONTE GRANDE
Monte Grande
1012.56.54006 CENTRO PRIVADO de MEDICINA RESPIRATORIA
Paraná
1012.56.54008 HOSPITAL ITALIANO de ROSARIO
Rosario
1012.56.54013 Boehringer Ingelheim Investigational Site
San Miguel de Tucumán
Poland10 sites
1012.56.48009 Boehringer Ingelheim Investigational Site
Bydgoszcz
1012.56.48006 Boehringer Ingelheim Investigational Site
Krakow
1012.56.48007 Boehringer Ingelheim Investigational Site
Krakow
1012.56.48004 Boehringer Ingelheim Investigational Site
Ostrow Wielkopolska
1012.56.48005 Boehringer Ingelheim Investigational Site
Poznan
1012.56.48002 Boehringer Ingelheim Investigational Site
Proszowice
1012.56.48010 Boehringer Ingelheim Investigational Site
Radom
1012.56.48001 Boehringer Ingelheim Investigational Site
Warsaw
1012.56.48011 Boehringer Ingelheim Investigational Site
Warsaw
1012.56.48003 Boehringer Ingelheim Investigational Site
Wroclaw
Greece9 sites
1012.56.30001 Boehringer Ingelheim Investigational Site
Athens
1012.56.30011 Boehringer Ingelheim Investigational Site
Athens
1012.56.30013 Boehringer Ingelheim Investigational Site
Athens
1012.56.30010 Boehringer Ingelheim Investigational Site
Corinth
1012.56.30009 Boehringer Ingelheim Investigational Site
Heraklion
1012.56.30007 Boehringer Ingelheim Investigational Site
Komotini
1012.56.30002 Boehringer Ingelheim Investigational Site
Larissa
1012.56.30014 Boehringer Ingelheim Investigational Site
Nafplion
1012.56.30003 Boehringer Ingelheim Investigational Site
Thessaloniki
United Kingdom9 sites
1012.56.44009 Boehringer Ingelheim Investigational Site
Ballieston, Glasgow
1012.56.44003 Boehringer Ingelheim Investigational Site
Bury Saint Edmonds
1012.56.44002 Boehringer Ingelheim Investigational Site
Cambridge
1012.56.44006 Colchester General Hospital
Colchester
1012.56.44007 Boehringer Ingelheim Investigational Site
Doncaster
1012.56.44001 Medicine Evaluation Unit
Manchester
1012.56.44008 The Staploe Medical Centre
Soham
1012.56.44005 Morriston Hospital
Swansea
1012.56.44010 Boehringer Ingelheim Investigational Site
Windsor
Russia8 sites
1012.56.07010 Boehringer Ingelheim Investigational Site
Kazan'
1012.56.07001 Boehringer Ingelheim Investigational Site
Moscow
1012.56.07002 Boehringer Ingelheim Investigational Site
Moscow
1012.56.07003 Boehringer Ingelheim Investigational Site
Moscow
1012.56.07005 Boehringer Ingelheim Investigational Site
Moscow
1012.56.07007 Boehringer Ingelheim Investigational Site
Saint Petersburg
1012.56.07008 Boehringer Ingelheim Investigational Site
Saint Petersburg
1012.56.07009 Boehringer Ingelheim Investigational Site
Saint Petersburg
South Africa8 sites
1012.56.27002 Boehringer Ingelheim Investigational Site
Bellville
1012.56.27008 Boehringer Ingelheim Investigational Site
Boksburg
1012.56.27001 Boehringer Ingelheim Investigational Site
Cape Town
1012.56.27004 Boehringer Ingelheim Investigational Site
Cape Town
1012.56.27005 Boehringer Ingelheim Investigational Site
Johannesburg
1012.56.27009 Boehringer Ingelheim Investigational Site
Orange Grove
1012.56.27003 Boehringer Ingelheim Investigational Site
Paarl
1012.56.27006 Boehringer Ingelheim Investigational Site
Park Town West
South Korea8 sites
1012.56.82009 Boehringer Ingelheim Investigational Site
Daegu
1012.56.82010 Boehringer Ingelheim Investigational Site
Geonggi-Do
1012.56.82008 Boehringer Ingelheim Investigational Site
Gyeonggi-do
1012.56.82001 Boehringer Ingelheim Investigational Site
Seoul
1012.56.82002 Boehringer Ingelheim Investigational Site
Seoul
1012.56.82005 Boehringer Ingelheim Investigational Site
Seoul
1012.56.82006 Boehringer Ingelheim Investigational Site
Seoul
1012.56.82007 Boehringer Ingelheim Investigational Site
Seoul
France6 sites
1012.56.3305A Centre hospitalier Germon & Gauthier
Béthune
1012.56.3303A Clinique de la Louvière
Lille
1012.56.3301A Hôpital Ambroise Paré
Marseille
1012.56.3304A Centre Médical Erdre Saint Augustin
Nantes
1012.56.3302A Cabinet Médical
Nice
1012.56.3302B Cabinet Médical
Nice
New Zealand5 sites
1012.56.64004 Boehringer Ingelheim Investigational Site
Dunedin
1012.56.64001 Boehringer Ingelheim Investigational Site
Grafton / Auckland
1012.56.64003 Boehringer Ingelheim Investigational Site
Hamilton
1012.56.64006 Boehringer Ingelheim Investigational Site
Tauranga
1012.56.64005 Boehringer Ingelheim Investigational Site
Wellington
Taiwan5 sites
1012.56.88604 Chang Gong Memorial Hospital
Keelong Town
1012.56.88605 Taichung Veterans General Hospital
Taichung
1012.56.88602 Taipei Veterans General Hospital
Taipei
1012.56.88603 National Taiwan University Hospital
Taipei
1012.56.88601 Chang Gung Memorial Hosp-Linkou
Taoyuan
Turkey (Türkiye)5 sites
1012.56.90001 Boehringer Ingelheim Investigational Site
Ankara
1012.56.90005 Boehringer Ingelheim Investigational Site
Antalya
1012.56.90003 Boehringer Ingelheim Investigational Site
Istanbul
1012.56.90006 Boehringer Ingelheim Investigational Site
Istanbul
1012.56.90002 Boehringer Ingelheim Investigational Site
Mersin
Ukraine5 sites
1012.56.38005 Boehringer Ingelheim Investigational Site
Dnyepropyetrovsk
1012.56.38006 Boehringer Ingelheim Investigational Site
Donetsk
1012.56.38001 Boehringer Ingelheim Investigational Site
Kiev
1012.56.38002 Boehringer Ingelheim Investigational Site
Kiev
1012.56.38004 Boehringer Ingelheim Investigational Site
Kiev
About this study
Official title: 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Atrovent Respimat (20 mcg), COMBIVENT MDI (36/206 mcg), Combivent Respimat (20 mcg/100 mcg), Placebo via corresponding inhaler for blinding purposes
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atrovent Respimat (20 mcg)Drug
COMBIVENT MDI (36/206 mcg)Drug
Combivent Respimat (20 mcg/100 mcg)Drug
Placebo via corresponding inhaler for blinding purposesDrug
| Study group | Role | What they receive |
|---|---|---|
| COMBIVENT Respimat 20/100 mcg | Experimental | Not described Receives: Drug: Combivent Respimat (20 mcg/100 mcg); Drug: Placebo via corresponding inhaler for blinding purposes |
| COMBIVENT CFC-MDI 36/206 mcg | Experimental | Not described Receives: Drug: COMBIVENT MDI (36/206 mcg); Drug: Placebo via corresponding inhaler for blinding purposes |
| Ipratropium Respimat 20 mcg | Experimental | Not described Receives: Drug: Atrovent Respimat (20 mcg); Drug: Placebo via corresponding inhaler for blinding purposes |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1 AUC0-6 at 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
Measured: Before drug administration to 6 hours after drug administration on Day 85
FEV1 AUC0-4 at 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
Measured: Before drug administration to 4 hours after drug administration on Day 85
FEV1 AUC4-6 at 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
Measured: Between 4 hours and 6 hours after drug administration on Day 85
Secondary outcomes (75)
FEV1 AUC0-6 at 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
Measured: Before drug administration to 6 hours after drug administration on Day 1
FEV1 AUC0-6 at 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
Measured: Before drug administration to 6 hours after drug administration on Day 29
FEV1 AUC0-6 at 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
Measured: Before drug administration to 6 hours after drug administration on Day 57
FEV1 AUC0-4 at 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
Measured: Before drug administration to 4 hours after drug administration on Day 1
FEV1 AUC0-4 at 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
Measured: Before drug administration to 4 hours after drug administration on Day 29
FEV1 AUC0-4 at 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
Measured: Before drug administration to 4 hours after drug administration on Day 57
FEV1 AUC4-6 at 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
Measured: Between 4 hours and 6 hours after drug administration on Day 1
FEV1 AUC4-6 at 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
Measured: Between 4 hours and 6 hours after drug administration on Day 29
FEV1 AUC4-6 at 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
Measured: Between 4 hours and 6 hours after drug administration on Day 57
Peak FEV1 Response at 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
Measured: Within the first 2-hour post-treatment interval on Day 1
Peak FEV1 Response at 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
Measured: Within the first 2-hour post-treatment interval on Day 29
Peak FEV1 Response at 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
Measured: Within the first 2-hour post-treatment interval on Day 57
Peak FEV1 Response at 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
Measured: Within the first 2-hour post-treatment interval on Day 85
Time to Onset of Therapeutic FEV1 Response 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
Measured: Within the first 2-hour post-treatment interval at Day 1
Time to Onset of Therapeutic FEV1 Response 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
Measured: Within the first 2-hour post-treatment interval at Day 29
Time to Onset of Therapeutic FEV1 Response 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
Measured: Within the first 2-hour post-treatment interval at Day 57
Time to Onset of Therapeutic FEV1 Response 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
Measured: Within the first 2-hour post-treatment interval at Day 85
Duration of Therapeutic FEV1 Response 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
Measured: During the 6-hour observation period after drug administration at Day 1
Duration of Therapeutic FEV1 Response 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
Measured: During the 6-hour observation period after drug administration at Day 29
Duration of Therapeutic FEV1 Response 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
Measured: During the 6-hour observation period after drug administration at Day 57
Duration of Therapeutic FEV1 Response 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
Measured: During the 6-hour observation period after drug administration at Day 85
Time to Peak FEV1 Response 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
Measured: Within the 6-hour post-treatment observation period at Day 1
Time to Peak FEV1 Response 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
Measured: Within the 6-hour post-treatment observation period at Day 29
Time to Peak FEV1 Response 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
Measured: Within the 6-hour post-treatment observation period at Day 57
Time to Peak FEV1 Response 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
Measured: Within the 6-hour post-treatment observation period at Day 85
FVC AUC0-6 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
Measured: Before drug administration to 6 hours after drug administration at Day 1
FVC AUC0-6 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
Measured: Before drug administration to 6 hours after drug administration at Day 29
FVC AUC0-6 at 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
Measured: Before drug administration to 6 hours after drug administration on Day 57
FVC AUC0-6 at 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
Measured: Before drug administration to 6 hours after drug administration on Day 85
FVC AUC0-4 at 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
Measured: Before drug administration to 4 hours after drug administration on Day 1
FVC AUC0-4 at 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
Measured: Before drug administration to 4 hours after drug administration on Day 29
FVC AUC0-4 at 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
Measured: Before drug administration to 4 hours after drug administration on Day 57
FVC AUC0-4 at 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
Measured: Before drug administration to 4 hours after drug administration on Day 85
FVC AUC4-6 at 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
Measured: Between 4 hours and 6 hours after drug administration on Day 1
FVC AUC4-6 at 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
Measured: Between 4 hours and 6 hours after drug administration on Day 29
FVC AUC4-6 at 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
Measured: Between 4 hours and 6 hours after drug administration on Day 57
FVC AUC4-6 at 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
Measured: Between 4 hours and 6 hours after drug administration on Day 85
Peak FVC Response 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
Measured: Within the first 2-hour post-treatment interval at Day 1
Peak FVC Response 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
Measured: Within the first 2-hour post-treatment interval at Day 29
Peak FVC Response 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
Measured: Within the first 2-hour post-treatment interval at Day 57
Peak FVC Response 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
Measured: Within the first 2-hour post-treatment interval at Day 85
Rescue Medication Use on Pulmonary Test Day 1
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 1
Measured: During the 6-hour pulmonary function testing after drug administration on Day 1
Rescue Medication Use on Pulmonary Test Day 29
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 29
Measured: During the 6-hour pulmonary function testing after drug administration on Day 29
Rescue Medication Use on Pulmonary Test Day 57
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 57
Measured: During the 6-hour pulmonary function testing after drug administration on Day 57
Rescue Medication Use on Pulmonary Test Day 85
Number of patients used rescue medication during the 6-hour pulmonary function testing after drug administration on Day 85
Measured: During the 6-hour pulmonary function testing after drug administration on Day 85
Night-time Rescue Medication Use
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)
Measured: During the 2-week baseline washout period and the 12-week treatment period
Daytime Rescue Medication Use
The mean number of puffs of rescue medication used during the daytime per week during the entire study (including baseline and on-treatment period)
Measured: During the 2-week baseline washout period and the 12-week treatment period
Night-time Symptom Score
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
Measured: During the 2-week baseline washout period and the 12-week treatment period
Daytime Symptom Score
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
Measured: During the 2-week baseline washout period and the 12-week treatment period
Trough Peak Expiratory Flow Rate (PEFR)
The weekly mean trough PEFR during the entire study (including baseline and on-treatment period)
Measured: 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
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.
Measured: Prior to pulmonary function test on Day 29
Physician's Global Evaluation Score on Pulmonary Function Testing 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.
Measured: Prior to pulmonary function test on Day 57
Physician's Global Evaluation Score on Pulmonary Function Testing 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.
Measured: Prior to pulmonary function test on Day 85
Percentage of Patients With Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the 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.
Measured: During the 12-week on-treatment period
COPD Exacerbation Rate During the 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.
Measured: During the 12-week on-treatment period
COPD Exacerbation During the 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.
Measured: During the 12-week on-treatment period
Frequency Distribution of Satisfaction Rating With Inhaler Attributes
Measured: 12 weeks
Mean Rating Scores of Satisfaction With Inhaler - Overall Feeling of Inhaling Medicine
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.
Measured: 12 weeks
Mean Rating Scores of Satisfaction With Inhaler - Feeling That the Inhaled Dose Goes to the Lung
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.
Measured: 12 weeks
Mean Rating Scores of Satisfaction With Inhaler - Telling the Amount of Medication Left
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.
Measured: 12 weeks
Mean Rating Scores of Satisfaction With Inhaler - The Inhaler Works Reliably
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.
Measured: 12 weeks
Mean Rating Scores of Satisfaction With Inhaler - Ease of Inhaling a Dose From the Inhaler
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.
Measured: 12 weeks
Mean Rating Scores of Satisfaction With Inhaler - Instructions for Use
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.
Measured: 12 weeks
Mean Rating Scores of Satisfaction With Inhaler - The Inhaler is Durable
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.
Measured: 12 weeks
Mean Rating Scores of Satisfaction With Inhaler - Using the Inhaler
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.
Measured: 12 weeks
Mean Rating Scores of Satisfaction With Inhaler - Speed of Medicine Coming Out of the Inhaler
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.
Measured: 12 weeks
Mean Rating Scores of Satisfaction With Inhaler - Overall Satisfaction With Inhaler
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.
Measured: 12 weeks
Device Preference (Respimat or MDI)
Frequency of patients due to device preference
Measured: 12 weeks
Rating of Action of Turning Clear Base of Respimat
Frequency of patients due to rating of action of turning clear base of Respimat
Measured: 12 weeks
Noncompartmental Pharmacokinetic Parameters of Ipratropium at Steady State
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).
Measured: Before drug administration to 6 hours after drug administration on Day 29
Noncompartmental Parameters of Albuterol at Steady State
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).
Measured: Before drug administration to 6 hours after drug administration on Day 29
Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-2 Hours
Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0-2, ss
Measured: Before drug administration to 2 hours after drug administration on Day 29
Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-2 Hours
Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0-2,ss.
Measured: Before drug administration to 2 hours after drug administration on Day 29
Cumulative Amounts of Ipratropium [μg] Excreted in Urine for 0-6 Hours
Cumulative amounts of Ipratropium [μg] excreted in urine - Planned time intervals 0-6,ss
Measured: Before drug administration to 6 hours after drug administration on Day 26
Cumulative Amounts of Albuterol [μg] Excreted in Urine for 0-6 Hours
Cumulative amounts of Albuterol [μg] excreted in urine - Planned time intervals 0-6, ss
Measured: Before drug administration to 6 hours after drug administration on Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00400153
- Sponsor's protocol ID
- 1012.56
- Status last verified
- Jun 2014
- First submitted
- 15 Nov 2006
- Last updated
- 13 Jun 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 20172704
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Combivent Respimat in Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT00400153
- Acronym / sponsor ID
- 1012.56
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,480 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Apr 2008 (actual)
- First posted
- 16 Nov 2006 (estimated)
- Results
- Posted 1 Jun 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COMBIVENT Respimat 20/100 mcg | Experimental | Drug: Combivent Respimat (20 mcg/100 mcg), Drug: Placebo via corresponding inhaler for blinding purposes |
| COMBIVENT CFC-MDI 36/206 mcg | Experimental | Drug: COMBIVENT MDI (36/206 mcg), Drug: Placebo via corresponding inhaler for blinding purposes |
| Ipratropium Respimat 20 mcg | Experimental | Drug: Atrovent Respimat (20 mcg), Drug: Placebo via corresponding inhaler for blinding purposes |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Outpatients of either sex, 40 years or older, with a diagnosis of COPD (FEV1 65% predicted normal and FEV1/FVC 70%).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atrovent Respimat (20 mcg) | Drug | Ipratropium Respimat 20 mcg |
| COMBIVENT MDI (36/206 mcg) | Drug | COMBIVENT CFC-MDI 36/206 mcg |
| Combivent Respimat (20 mcg/100 mcg) | Drug | COMBIVENT Respimat 20/100 mcg |
| Placebo via corresponding inhaler for blinding purposes | Drug | COMBIVENT CFC-MDI 36/206 mcg, COMBIVENT Respimat 20/100 mcg, Ipratropium Respimat 20 mcg |
Primary outcome
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
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
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
75 secondary outcomes
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20172704Zuwallack 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
180 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Atrovent Respimat (20 mcg), COMBIVENT MDI (36/206 mcg) and Combivent Respimat (20 mcg/100 mcg) in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 180 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 180 sites in United States, Argentina, Poland, Greece, United Kingdom and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1 AUC0-6 at Day 85 (time frame: Before drug administration to 6 hours after drug administration on Day 85). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00400153, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2014.