Spiriva (Tiotropium Bromide) Assessment of FEV1 - (SAFE-Portugal).
Pulmonary Disease, Chronic Obstructive
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Main Inclusion criteria: 1.Diagnosis of chronic obstructive pulmonary disease. 2.Patient is male or female, age <=than 40 years. 3. Patient has a smoking history of <=10 pack-year.4.Patient is able to be trained in the proper use of HandiHaler 5.Patient is able to be trained to perform technically satisfactory spirometry and must be able to maintain records during the study period as required by the protocol. 6.Patient must be willing and able to sign informed consent prior to participation in the study i.e. prior to washout of their usual pulmonary medications. Main exclusion criteria 1.History of asthma, allergic rhinitis or atopy. 2. A lower respiratory tract infection or any COPD exacerbation in the past 4 weeks prior to Visit 1 or during the two week Screening Period 3.History of life threatening bronchial obstruction, cystic fibrosis or bronchiectasis 4. Oral corticosteroid medication if initiated or modified within the last 6 weeks prior to Visit 1 or if daily dose > 10 mg prednisone or 20 mg or more every other day (or equivalent). 5.Patients who have started or stopped an exercise rehabilitation program within 4 weeks of visit 6.Patients who regularly use daytime oxygen therapy for more than one hour per day and who, in the investigator's opinion, will be unable to abstain from the use of oxygen therapy during testing. 7. Patients who have undergone thoracotomy with pulmonary resection or lobectomy (lung volume reduction surgery). 8.Tuberculosis with indication for treatment. 9. Recent history (i.e. 6 months or less) of myocardial infarction.10. Patients with known moderate or severe renal insufficiency.11. Patients with symptomatic prostatic hypertrophy or bladder neck obstruction. 12.Patients with known narrow-angle glaucoma.13.History of unstable arrhythmia with a life threatening event or change of therapy during the past year.14. History of cancer, other than treated basal cell carcinoma, within the last 5 years 15.Intolerance to anticholinergic containing products, and/or to lactose or any other components of the inhalation capsule delivery system.16.Patients who are being treated with beta-blockers including eye drops.17.Patients who are being treated with antihistamines (H1 receptor antagonists), for asthma or excluded allergic conditions (See Exclusion Criteria No.2).18.Patients who are being treated with monoamine oxidase inhibitors or tricyclic antidepressants.19. Patients who are being treated with oral beta-adrenergics.20. Patients who have taken cromolyn sodium or nedocromil sodium within 1 month of Visit 1.21.Patients who have taken antileukotrienes or leukotriene receptor antagonists within 1 month of Visit 1. 22.Concomitant or recent (within the last month or 6 half lives, whichever is greater) use of investigational drugs prior to the screening visit (Visit 1). 23. Significant alcohol or drug abuse within the past 12 months. 24. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception.24. Previous participation in this study (i.e. randomized).26. Patients who have taken commercially available Spiriva. 27.History of any clinically significant disease, defined as a disease which in the opinion of the investigator may the patient at risk because of participation in the study OR a disease which may influence the results of the study OR the patient's ability to participate in the study.
Sites / Locations
- Hospital Garcia de Orta
- Hospital Fernando Fonseca
- Hospital Santo Espírito de Angra do Heroismo
- Hospital Infante D. Pedro
- Unidade Funcional de Infecciologia
- Hospital de S. Marcos
- Hospitais da Universidade de Coimbra
- Centro Hospitalar de Coimbra
- Centro Hospitalar da Cova da Beira
- Hospital Distrital de Faro
- Hospital Distrital da Figueira da Foz
- Centro Hospitalar do Funchal
- Hospital de Sousa Martins
- Hospital Senhora da Oliveira
- Hospital Particular de Lisboa
- Instituto Português de Oncologia Francisco Gentil
- Hospital de Santa Marta - HCL
- Hospital Pulido Valente
- Hospital Egas Moniz
- Hospital Santa Maria
- Unidade Local de Saúde de Matosinhos
- Hospital Divino Espírito Santo
- Hospital Barlavento Algarvio
- Hospital Geral de Santo António
- Hospital de São João
- Hospital Joaquim Urbano
- Hospital Distrital de Santarém
- Hospital de S. Bernardo
- Hospital de S. Sebastião
- Hospital Rainha Santa Isabel
- Centro Hospitalar de V. N. de Gaia
- Hospital de S. Teotónio
- Hospital Espírito Santo