Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients.
NCT ID: NCT00388882
Last Updated: 2023-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
327 participants
INTERVENTIONAL
2006-10-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
Interventions
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tiotropium
ipratropium bromide / albuterol
Eligibility Criteria
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Inclusion Criteria
* Age: \>= 40 years
* Current or ex-smoker with a \>= 10 pack-year smoking history
* Use of Combivent® MDI for \>= 1 month prior to Visit 1 Spirometric criteria (determined at study visits):
* Post-bronchodilator FEV1 \<= 70% (Visit 1)
* Pre-bronchodilator FEV1 \<= 65% of predicted and FEV1/FVC \<= 70% (Visit 2)
Exclusion Criteria
* History of thoracotomy with pulmonary resection
* History of CF, alpha 1 antitrypsin deficiency or interstitial lung disease
* Daytime use of oxygen therapy for \> 1 hour per day or if unable to abstain from using oxygen during PFTs
* Any respiratory tract infection or COPD exacerbation in 6 weeks prior to Visit 1
* Recent history 6 months or less of MI
* Unstable or life-threatening cardiac arrhythmias
* Hospitalization for CHF during past year
* Malignancy for which patient is receiving chemo or radiation therapy
* Pregnant or nursing women
* Known hypersensitivity to ipratropium or carrier substances, including related food products such as soybean, peanuts, or lactose
* Use of SPIRIVA® 3 months prior to Visit 1
* Symptomatic of prostatic hypertrophy or bladder neck obstruction
* Known narrow- angle glaucoma
* Participating in a pulmonary rehab program within 4 weeks of Visit 1
40 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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205.346.107 Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
205.346.104 Boehringer Ingelheim Investigational Site
Lakewood, California, United States
205.346.108 Boehringer Ingelheim Investigational Site
Sepulveda, California, United States
205.346.101 Boehringer Ingelheim Investigational Site
Torrance, California, United States
205.346.106 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
205.346.102 Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho, United States
205.346.109 Boehringer Ingelheim Investigational Site
Shreveport, Louisiana, United States
205.346.110 Boehringer Ingelheim Investigational Site
Philadelphia, Pennsylvania, United States
205.346.105 Boehringer Ingelheim Investigational Site
Charleston, South Carolina, United States
205.346.103 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
205.346.510
Bs As, , Argentina
205.346.502
Buenos Aires, , Argentina
205.346.503
Buenos Aires, , Argentina
205.346.508
Buenos Airess, , Argentina
205.346.505
Mendoza, , Argentina
205.346.509
Rosario, Santa Fe, , Argentina
205.346.511
Rosario, Santa Fé, , Argentina
205.346.504 Instituto de Patologías Respiratorias
San Miguel de Tucumán, , Argentina
205.346.401 Boehringer Ingelheim Investigational Site
Alytus, , Lithuania
205.346.404 Boehringer Ingelheim Investigational Site
Kaunas, , Lithuania
205.346.405 Boehringer Ingelheim Investigational Site
Kaunas, , Lithuania
205.346.411 Boehringer Ingelheim Investigational Site
Klaipėda, , Lithuania
205.346.409 Boehringer Ingelheim Investigational Site
Šiauliai, , Lithuania
205.346.408 Boehringer Ingelheim Investigational Site
Utena, , Lithuania
205.346.402 Boehringer Ingelheim Investigational Site
Vilnius, , Lithuania
205.346.406 Boehringer Ingelheim Investigational Site
Vilnius, , Lithuania
205.346.407 Boehringer Ingelheim Investigational Site
Vilnius, , Lithuania
205.346.302 Boehringer Ingelheim Investigational Site
Bratislava, , Slovakia
205.346.305 Boehringer Ingelheim Investigational Site
Bratislava, , Slovakia
205.346.301 Boehringer Ingelheim Investigational Site
Košice, , Slovakia
205.346.303 Boehringer Ingelheim Investigational Site
Levica, , Slovakia
205.346.304 Boehringer Ingelheim Investigational Site
Lučenec, , Slovakia
205.346.306 Boehringer Ingelheim Investigational Site
Štúrovo, , Slovakia
205.346.204 Boehringer Ingelheim Investigational Site
Aylesbury, , United Kingdom
205.346.203 Boehringer Ingelheim Investigational Site
Greenisland, , United Kingdom
205.346.201 Boehringer Ingelheim Investigational Site
Nottingham, , United Kingdom
205.346.207 Boehringer Ingelheim Investigational Site
Soham, , United Kingdom
205.346.209 Boehringer Ingelheim Investigational Site
Swansea, , United Kingdom
205.346.206 Boehringer Ingelheim Investigational Site
Westbury on Trym, , United Kingdom
205.346.205 Boehringer Ingelheim Investigational Site
Windsor, , United Kingdom
Countries
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Related Links
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Related Info
Other Identifiers
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EudraCT 2006-000822-30
Identifier Type: -
Identifier Source: secondary_id
205.346
Identifier Type: -
Identifier Source: org_study_id