Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
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
| NCT number | NCT00388882 |
| Other study ID # | 205.346 |
| Secondary ID | EudraCT 2006-000 |
| Status | Completed |
| Phase | Phase 4 |
| First received | |
| Last updated | |
| Start date | October 4, 2006 |
| Verified date | November 2023 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 327 |
| Est. completion date | |
| Est. primary completion date | October 8, 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | 205.346.510 | Bs As | |
| Argentina | 205.346.502 | Buenos Aires | |
| Argentina | 205.346.503 | Buenos Aires | |
| Argentina | 205.346.508 | Buenos Airess | |
| Argentina | 205.346.505 | Mendoza | |
| Argentina | 205.346.509 | Rosario, Santa Fe | |
| Argentina | 205.346.511 | Rosario, Santa Fé | |
| Argentina | 205.346.504 Instituto de Patologías Respiratorias | San Miguel de Tucumán | |
| Lithuania | 205.346.401 Boehringer Ingelheim Investigational Site | Alytus | |
| Lithuania | 205.346.404 Boehringer Ingelheim Investigational Site | Kaunas | |
| Lithuania | 205.346.405 Boehringer Ingelheim Investigational Site | Kaunas | |
| Lithuania | 205.346.411 Boehringer Ingelheim Investigational Site | Klaipeda | |
| Lithuania | 205.346.409 Boehringer Ingelheim Investigational Site | Siauliai | |
| Lithuania | 205.346.408 Boehringer Ingelheim Investigational Site | Utena | |
| Lithuania | 205.346.402 Boehringer Ingelheim Investigational Site | Vilnius | |
| Lithuania | 205.346.406 Boehringer Ingelheim Investigational Site | Vilnius | |
| Lithuania | 205.346.407 Boehringer Ingelheim Investigational Site | Vilnius | |
| Slovakia | 205.346.302 Boehringer Ingelheim Investigational Site | Bratislava | |
| Slovakia | 205.346.305 Boehringer Ingelheim Investigational Site | Bratislava | |
| Slovakia | 205.346.301 Boehringer Ingelheim Investigational Site | Kosice | |
| Slovakia | 205.346.303 Boehringer Ingelheim Investigational Site | Levica | |
| Slovakia | 205.346.304 Boehringer Ingelheim Investigational Site | Lucenec | |
| Slovakia | 205.346.306 Boehringer Ingelheim Investigational Site | Sturovo | |
| United Kingdom | 205.346.204 Boehringer Ingelheim Investigational Site | Aylesbury | |
| United Kingdom | 205.346.203 Boehringer Ingelheim Investigational Site | Greenisland | |
| United Kingdom | 205.346.201 Boehringer Ingelheim Investigational Site | Nottingham | |
| United Kingdom | 205.346.207 Boehringer Ingelheim Investigational Site | Soham | |
| United Kingdom | 205.346.209 Boehringer Ingelheim Investigational Site | Swansea | |
| United Kingdom | 205.346.206 Boehringer Ingelheim Investigational Site | Westbury On Trym | |
| United Kingdom | 205.346.205 Boehringer Ingelheim Investigational Site | Windsor | |
| United States | 205.346.105 Boehringer Ingelheim Investigational Site | Charleston | South Carolina |
| United States | 205.346.102 Boehringer Ingelheim Investigational Site | Coeur d'Alene | Idaho |
| United States | 205.346.104 Boehringer Ingelheim Investigational Site | Lakewood | California |
| United States | 205.346.110 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania |
| United States | 205.346.107 Boehringer Ingelheim Investigational Site | Phoenix | Arizona |
| United States | 205.346.108 Boehringer Ingelheim Investigational Site | Sepulveda | California |
| United States | 205.346.109 Boehringer Ingelheim Investigational Site | Shreveport | Louisiana |
| United States | 205.346.103 Boehringer Ingelheim Investigational Site | Spartanburg | South Carolina |
| United States | 205.346.101 Boehringer Ingelheim Investigational Site | Torrance | California |
| United States | 205.346.106 Boehringer Ingelheim Investigational Site | Wheat Ridge | Colorado |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
United States, Argentina, Lithuania, Slovakia, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Trough FEV1 | after 12 weeks of treatment | ||
| Primary | FEV1 AUC0-6 hours | after 12 weeks of treatment | ||
| Secondary | Peak FEV1 | 12 weeks | ||
| Secondary | Peak FEV1 | after first dose and 6 week | ||
| Secondary | FEV1 AUC0-6 hours | after first dose and 6 weeks | ||
| Secondary | Trough FEV1 | at 6 weeks | ||
| Secondary | Peak FVC at all clinic visits | 12 weeks | ||
| Secondary | AUC0-6 hours FVC at all clinic visits | 12 weeks | ||
| Secondary | Trough FVC | at 6 and 12 weeks | ||
| Secondary | Individual FEV1 measurements | 12 weeks | ||
| Secondary | Individual FVC measurements | 12 weeks | ||
| Secondary | Use of Albuterol (scheduled and rescue) | 12 weeks | ||
| Secondary | Patient Global Evaluation | 12 weeks | ||
| Secondary | Physician Global Evaluation | 12 weeks | ||
| Secondary | PEFR (Peak expiratory flow rate) measured by the patient at home twice daily | 12 weeks | ||
| Secondary | Occurrence of adverse events | 12 weeks | ||
| Secondary | Vital Signs | 12 weeks |
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