NCT00388882CompletedPhase 4
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
Boehringer Ingelheim40 sites in 5 countries327 target enrollmentStarted: October 4, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 327
- Locations
- 40
- Primary Endpoint
- Trough FEV1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Trough FEV1
Time Frame: after 12 weeks of treatment
FEV1 AUC0-6 hours
Time Frame: after 12 weeks of treatment
Secondary Outcomes
- Trough FVC(at 6 and 12 weeks)
- Peak FEV1(after first dose and 6 week)
- Individual FEV1 measurements(12 weeks)
- Individual FVC measurements(12 weeks)
- Use of Albuterol (scheduled and rescue)(12 weeks)
- Patient Global Evaluation(12 weeks)
- Physician Global Evaluation(12 weeks)
- Occurrence of adverse events(12 weeks)
- Vital Signs(12 weeks)
- FEV1 AUC0-6 hours(after first dose and 6 weeks)
- Trough FEV1(at 6 weeks)
- Peak FVC at all clinic visits(12 weeks)
- AUC0-6 hours FVC at all clinic visits(12 weeks)
- PEFR (Peak expiratory flow rate) measured by the patient at home twice daily(12 weeks)
- Peak FEV1(12 weeks)
Investigators
Study Sites (40)
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