Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
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.
Interventions
DRUGtiotropium
DRUGipratropium bromide / albuterol
Sponsors
Boehringer Ingelheim
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Trough FEV1 | after 12 weeks of treatment |
| FEV1 AUC0-6 hours | after 12 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Trough FEV1 | at 6 weeks |
| Peak FVC at all clinic visits | 12 weeks |
| AUC0-6 hours FVC at all clinic visits | 12 weeks |
| Trough FVC | at 6 and 12 weeks |
| Individual FEV1 measurements | 12 weeks |
| Individual FVC measurements | 12 weeks |
| Peak FEV1 | 12 weeks |
| Patient Global Evaluation | 12 weeks |
| Physician Global Evaluation | 12 weeks |
| PEFR (Peak expiratory flow rate) measured by the patient at home twice daily | 12 weeks |
| Occurrence of adverse events | 12 weeks |
| Vital Signs | 12 weeks |
| Use of Albuterol (scheduled and rescue) | 12 weeks |
| FEV1 AUC0-6 hours | after first dose and 6 weeks |
Countries
Argentina, Lithuania, Slovakia, United Kingdom, United States
Outcome results
None listed