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

CompletadoFase 4ClinicalTrials.gov

ID: NCT00388882Tipo: INTERVENTIONALInicio: 4 de oct de 2006

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

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)

Criterios de exclusión

Pregnant or nursing women
Malignancy for which patient is receiving chemo or radiation therapy
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
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
Hospitalization for CHF during past year
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

Intervenciones

drug

tiotropium

drug

ipratropium bromide / albuterol

Ubicaciones

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, Argentina

Patrocinadores

PrincipalBoehringer Ingelheim

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