Spiriva (Tiotropium Bromide) Assessment of FEV1 - (SAFE-Portugal).

NCT ID: NCT00239408

Last Updated: 2013-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 311 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-12-31
• Study Completion Date: 2004-04-30

Brief Summary

Evaluate whether the effect of inhaled tiotropium bromide on the change in trough forced expiratory volume (FEV1), compared to placebo in patients with chronic obstructive pulmonary disease (COPD), is affected by smoking status.

Detailed Description

Evaluate whether the effect of inhaled tiotropium bromide on the change in trough FEV1 from baseline to week 12 compared to placebo in patients with COPD is affected by smoking status. Secondary objectives include FEV1 at interim visit and FVC at on-treatment visits, use of rescue medication, COPD symptom scores, Physicians Global Evaluation and EQ-5D scores.

Study Hypothesis:

The primary objective of the study is to show superiority of tiotropium against placebo with respect to trough FEV1 at 12 weeks. Then the 5% two-sided hypotheses test is:

H0: Mean trough FEV1 at 12 weeks in tiotropium = Mean trough FEV1 at 12 weeks in placebo H1: Mean trough FEV1 at 12 weeks in tiotropium unequal Mean trough FEV1 at 12 weeks in placebo If the null hypothesis is rejected in favour of the alternative hypothesis (H1) based on all patients, the same hypotheses will be tested in both sub-populations of current and ex-smokers respectively.

Comparison(s):

Tiotropium bromide - 18 mcg capsule inhaled via the HandiHaler vs Placebo powder capsules for oral inhalation, via the HandiHaler.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Pulmonary function Testing

Intervention Type: DEVICE

tiotropium bromide

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Principal Investigators

Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

B.I. Portugal Lda

Locations

Hospital Garcia de Orta

Almada, , Portugal

Hospital Fernando Fonseca

Amadora, , Portugal

Hospital Santo Espírito de Angra do Heroismo

Angra Do Heroismo - Açores, , Portugal

Hospital Infante D. Pedro

Aveiro, , Portugal

Unidade Funcional de Infecciologia

Barreiro, , Portugal

Hospital de S. Marcos

Braga, , Portugal

Hospitais da Universidade de Coimbra

Coimbra, , Portugal

Centro Hospitalar de Coimbra

Coimbra, , Portugal

Centro Hospitalar da Cova da Beira

Covilha, , Portugal

Hospital Espírito Santo

Evora, , Portugal

Hospital Distrital de Faro

Faro, , Portugal

Hospital Distrital da Figueira da Foz

Figueira da Foz Municipality, , Portugal

Centro Hospitalar do Funchal

Funchal, , Portugal

Hospital de Sousa Martins

Guarda, , Portugal

Hospital Senhora da Oliveira

Guimarães, , Portugal

Hospital Particular de Lisboa

Lisbon, , Portugal

Instituto Português de Oncologia Francisco Gentil

Lisbon, , Portugal

Hospital de Santa Marta - HCL

Lisbon, , Portugal

Hospital Egas Moniz

Lisbon, , Portugal

Hospital Santa Maria

Lisbon, , Portugal

Hospital Pulido Valente

Lisbon, , Portugal

Unidade Local de Saúde de Matosinhos

Matosinhos Municipality, , Portugal

Hospital Divino Espírito Santo

Ponta Delgada - Açores, , Portugal

Hospital Barlavento Algarvio

Portimão, , Portugal

Hospital Geral de Santo António

Porto, , Portugal

Hospital de São João

Porto, , Portugal

Hospital Joaquim Urbano

Porto, , Portugal

Hospital de S. Sebastião

Santa Maria da Feira, , Portugal

Hospital Distrital de Santarém

Santarém, , Portugal

Hospital de S. Bernardo

Setúbal, , Portugal

Hospital Rainha Santa Isabel

Torres Novas, , Portugal

Centro Hospitalar de V. N. de Gaia

V.N.Gaia, , Portugal

Hospital de S. Teotónio

Viseu, , Portugal

Countries

Portugal

Other Identifiers

205.282

Identifier Type: -

Identifier Source: org_study_id