A Randomized, Double-blind, Parallel Group Trial Comparing 12 Weeks Treatment With Tiotropium 18 mcg Daily to Combivent MDI 2 Actuations Qid in COPD Patients Previously Prescribed Combivent MDI
- NCT00359788
- PHASE4
- INTERVENTIONAL
Last updated: 2014-05-16
Purpose of Trial
The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotropium HandiHaler 18 micrograms (mcg) daily compared to Combivent Metered Dose Inhaler (MDI) Chlorofluorocarbon Inhalation Aerosol 2 actuations four times a day in Chronic Obstructive Pulmonary Disease (COPD) patients currently prescribed Combivent® MDI.
This study is for people with
Pulmonary Disease, Chronic Obstructive
Interventions being studied
tiotropium
Combivent (Ipratropium/Albuterol)
Inclusion Criteria: Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) Age: greater than or equal to 40 years
* Current or ex-smoker with a \>= 10 pack-year smoking history
* Use of Combivent® Metered Dose Inhaler (MDI)for \>= 1 month prior to Visit 1
Spirometric criteria (determined at study visits):
* Post-bronchodilator Forced Expiratory Volume in one second (FEV1) \<= 70% (Visit 1)
* Pre-bronchodilator FEV1 \<= 65% of predicted and FEV1/Forced Vital Capacity (FVC) \<= 70% (Visit 2)
Exclusion Criteria:
Clinical history of asthma
* History of thoracotomy with pulmonary resection
* History of Cystic Fibrosis, alpha 1 antitrypsin deficiency or interstitial lung disease
* Daytime use of oxygen therapy for \> 1 hour per day or if unable to abstain fr om using oxygen during Pulmonary Function Tests
* Any respiratory tract infection or COPD exacerbation in 6 weeks prior to Visit 1
* Recent history 6 months or less of Myocardial Infarction
* Unstable or life-threatening cardiac arrhythmias
* Hospitalization for Congestive Heart Failure 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
ELIGIBILITY
Gender: ALL
Age: 40+
Healthy Volunteers: No
31 Locations
Birmingham
205.325.904 Boehringer Ingelheim Investigational Site
Alabama, United States
Phoenix
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Tucson
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West Haven
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Salt Lake City
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Richmond
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Virginia, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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ClinicalTrials.gov