A Randomized, Double-blind, Double-dummy, Parallel Group Trial Comparing 12 Weeks Treatment With Tiotropium Inhalation Capsules 18 mcg Via the HandiHaler® Once Daily to Combivent® Inhalation Aerosol CFC MDI 2 Actuations q.i.d. in COPD Patients Currently Prescribed Combivent® Inhalation Aerosol CFC MDI
- NCT00388882
- PHASE4
- INTERVENTIONAL
Last updated: 2023-12-01
Purpose of Trial
The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotro pium HandiHaler® 18 mcg daily compared to Combivent® MDI CFC Inhalation Aerosol 2 actuations qid in COPD patients currently prescribed Combivent® MDI.
This study is for people with
Pulmonary Disease, Chronic Obstructive
Interventions being studied
tiotropium
ipratropium bromide / albuterol
Inclusion Criteria:
* Diagnosis of COPD
* 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:
* Clinical history of asthma
* 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
ELIGIBILITY
Gender: ALL
Age: 40+
Healthy Volunteers: No
10 Locations
Phoenix
205.346.107 Boehringer Ingelheim Investigational Site
Arizona, United States
Lakewood
205.346.104 Boehringer Ingelheim Investigational Site
California, United States
Sepulveda
205.346.108 Boehringer Ingelheim Investigational Site
California, United States
Torrance
205.346.101 Boehringer Ingelheim Investigational Site
California, United States
Wheat Ridge
205.346.106 Boehringer Ingelheim Investigational Site
Colorado, United States
Coeur d'Alene
205.346.102 Boehringer Ingelheim Investigational Site
Idaho, United States
Shreveport
205.346.109 Boehringer Ingelheim Investigational Site
Louisiana, United States
Philadelphia
205.346.110 Boehringer Ingelheim Investigational Site
Pennsylvania, United States
Charleston
205.346.105 Boehringer Ingelheim Investigational Site
South Carolina, United States
Spartanburg
205.346.103 Boehringer Ingelheim Investigational Site
South Carolina, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov