Trial Comparing Treatment With Tiotropium Inhalation Capsules to Combivent® Inhalation Aerosol in COPD Patients.



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:12/30/2017
Start Date:October 2006

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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

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.


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
We found this trial at
11
sites
5386
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Bs As,
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Charleston, South Carolina
525
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Charleston, SC
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1748
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Coeur D'Alene, ID
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1971
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Lakewood, CA
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Philadelphia, Pennsylvania
416
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Philadelphia, PA
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1662
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Phoenix, AZ
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1980
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Sepulveda, CA
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787
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Shreveport, LA
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Spartanburg, South Carolina
351
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Spartanburg, SC
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1983
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Torrance, CA
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1166
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Wheat Ridge, CO
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