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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00239408
First received: October 14, 2005
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Device: Pulmonary function Testing
Drug: tiotropium bromide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Spiriva Assessment of FEV1 - (SAFE-Portugal). The Effect of Inhaled Tiotropium Bromide (18 Mcg Once Daily) on the Change in FEV1 During Treatment in Patients With COPD. A Three-month Parallel Group, Double-blind, Randomised, Placebo-controlled Study.

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Change in trough FEV1 after 12 weeks of treatment. [ Time Frame: week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Trough FEV1 at interim visit [ Time Frame: week 6 ] [ Designated as safety issue: No ]
  • Change in FVC at weeks 6 and 12 [ Time Frame: week 6, week 12 ] [ Designated as safety issue: No ]
  • Use of rescue medication (daytime and night-time) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Assessment of COPD symptoms [ Time Frame: week 0, week 6, week 12 ] [ Designated as safety issue: No ]
  • The Physician's Global Evaluation at Visits 2 and 4 [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
  • Quality of life questionnaire (EQ-5D) at Visits 2 and 4 [ Time Frame: week 0, week 12 ] [ Designated as safety issue: No ]
  • Pulse Rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Blood Pressure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 311
Study Start Date: December 2002
Estimated Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00239408

Locations
Portugal
Hospital Garcia de Orta
Almada, Portugal, 2800-525 Almada
Hospital Fernando Fonseca
Amadora, Portugal, 2720-276Amadora
Hospital Santo Espírito de Angra do Heroismo
Angra do Heroismo - Açores, Portugal, 9700-856
Hospital Infante D. Pedro
Aveiro, Portugal, 3810
Unidade Funcional de Infecciologia
Barreiro, Portugal, 2830-094
Hospital de S. Marcos
Braga, Portugal, 4701-965
Hospitais da Universidade de Coimbra
Coimbra, Portugal, 3000-075
Centro Hospitalar de Coimbra
Coimbra, Portugal, 3040-853
Centro Hospitalar da Cova da Beira
Covilhã, Portugal, 6200
Hospital Distrital de Faro
Faro, Portugal, 8000-386
Hospital Distrital da Figueira da Foz
Figueira da Foz, Portugal, 3080-707
Centro Hospitalar do Funchal
Funchal, Portugal, 9004-514
Hospital de Sousa Martins
Guarda, Portugal, 6300-749
Hospital Senhora da Oliveira
Guimarães, Portugal, 4810-055
Hospital Pulido Valente
Lisboa, Portugal, 1769-001
Hospital de Santa Marta - HCL
Lisboa, Portugal, 1196-024
Instituto Português de Oncologia Francisco Gentil
Lisboa, Portugal, 1099-023
Hospital Particular de Lisboa
Lisboa, Portugal, 1069-142
Hospital Santa Maria
Lisbon, Portugal, 1649-035
Hospital Egas Moniz
Lisbon, Portugal, 1349-019
Unidade Local de Saúde de Matosinhos
Matosinhos, Portugal, 4454-509
Hospital Divino Espírito Santo
Ponta Delgada - Açores, Portugal, 9500-370
Hospital Barlavento Algarvio
Portimão, Portugal, 8500-338
Hospital Joaquim Urbano
Porto, Portugal, 4300
Hospital Geral de Santo António
Porto, Portugal, 4050-011
Hospital de São João
Porto, Portugal, 4200-319
Hospital Distrital de Santarém
Santarém, Portugal, 2000-153
Hospital de S. Bernardo
Setúbal, Portugal, 2910
Hospital de S. Sebastião
Sta. Maria da Feira, Portugal, 4520-211
Hospital Rainha Santa Isabel
Torres Novas, Portugal, 2354-909
Centro Hospitalar de V. N. de Gaia
V.N.Gaia, Portugal, 4434-502
Hospital de S. Teotónio
Viseu, Portugal, 3504-509
Hospital Espírito Santo
Évora, Portugal, 7000
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator B.I. Portugal Lda
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00239408     History of Changes
Other Study ID Numbers: 205.282
Study First Received: October 14, 2005
Last Updated: October 31, 2013
Health Authority: Portugal: INFARMED

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Tiotropium
Bromides
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014