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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 4
Locations
Portugal
Study Type
Interventional
Intervention
Pulmonary function Testing
tiotropium bromide
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Outcomes

Primary Outcome Measures

Change in trough FEV1 after 12 weeks of treatment.

Secondary Outcome Measures

Trough FEV1 at interim visit
Change in FVC at weeks 6 and 12
Use of rescue medication (daytime and night-time)
Assessment of COPD symptoms
The Physician's Global Evaluation at Visits 2 and 4
Quality of life questionnaire (EQ-5D) at Visits 2 and 4
Pulse Rate
Blood Pressure

Full Information

First Posted
October 14, 2005
Last Updated
October 31, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00239408
Brief Title
Spiriva (Tiotropium Bromide) Assessment of FEV1 - (SAFE-Portugal).
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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
April 2004 (Actual)
Study Completion Date
April 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
311 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Pulmonary function Testing
Intervention Type
Drug
Intervention Name(s)
tiotropium bromide
Primary Outcome Measure Information:
Title
Change in trough FEV1 after 12 weeks of treatment.
Time Frame
week 12
Secondary Outcome Measure Information:
Title
Trough FEV1 at interim visit
Time Frame
week 6
Title
Change in FVC at weeks 6 and 12
Time Frame
week 6, week 12
Title
Use of rescue medication (daytime and night-time)
Time Frame
12 weeks
Title
Assessment of COPD symptoms
Time Frame
week 0, week 6, week 12
Title
The Physician's Global Evaluation at Visits 2 and 4
Time Frame
week 0, week 12
Title
Quality of life questionnaire (EQ-5D) at Visits 2 and 4
Time Frame
week 0, week 12
Title
Pulse Rate
Time Frame
12 weeks
Title
Blood Pressure
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
B.I. Portugal Lda
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Garcia de Orta
City
Almada
ZIP/Postal Code
2800-525 Almada
Country
Portugal
Facility Name
Hospital Fernando Fonseca
City
Amadora
ZIP/Postal Code
2720-276Amadora
Country
Portugal
Facility Name
Hospital Santo Espírito de Angra do Heroismo
City
Angra do Heroismo - Açores
ZIP/Postal Code
9700-856
Country
Portugal
Facility Name
Hospital Infante D. Pedro
City
Aveiro
ZIP/Postal Code
3810
Country
Portugal
Facility Name
Unidade Funcional de Infecciologia
City
Barreiro
ZIP/Postal Code
2830-094
Country
Portugal
Facility Name
Hospital de S. Marcos
City
Braga
ZIP/Postal Code
4701-965
Country
Portugal
Facility Name
Hospitais da Universidade de Coimbra
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Centro Hospitalar de Coimbra
City
Coimbra
ZIP/Postal Code
3040-853
Country
Portugal
Facility Name
Centro Hospitalar da Cova da Beira
City
Covilhã
ZIP/Postal Code
6200
Country
Portugal
Facility Name
Hospital Distrital de Faro
City
Faro
ZIP/Postal Code
8000-386
Country
Portugal
Facility Name
Hospital Distrital da Figueira da Foz
City
Figueira da Foz
ZIP/Postal Code
3080-707
Country
Portugal
Facility Name
Centro Hospitalar do Funchal
City
Funchal
ZIP/Postal Code
9004-514
Country
Portugal
Facility Name
Hospital de Sousa Martins
City
Guarda
ZIP/Postal Code
6300-749
Country
Portugal
Facility Name
Hospital Senhora da Oliveira
City
Guimarães
ZIP/Postal Code
4810-055
Country
Portugal
Facility Name
Hospital Particular de Lisboa
City
Lisboa
ZIP/Postal Code
1069-142
Country
Portugal
Facility Name
Instituto Português de Oncologia Francisco Gentil
City
Lisboa
ZIP/Postal Code
1099-023
Country
Portugal
Facility Name
Hospital de Santa Marta - HCL
City
Lisboa
ZIP/Postal Code
1196-024
Country
Portugal
Facility Name
Hospital Pulido Valente
City
Lisboa
ZIP/Postal Code
1769-001
Country
Portugal
Facility Name
Hospital Egas Moniz
City
Lisbon
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Hospital Santa Maria
City
Lisbon
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Unidade Local de Saúde de Matosinhos
City
Matosinhos
ZIP/Postal Code
4454-509
Country
Portugal
Facility Name
Hospital Divino Espírito Santo
City
Ponta Delgada - Açores
ZIP/Postal Code
9500-370
Country
Portugal
Facility Name
Hospital Barlavento Algarvio
City
Portimão
ZIP/Postal Code
8500-338
Country
Portugal
Facility Name
Hospital Geral de Santo António
City
Porto
ZIP/Postal Code
4050-011
Country
Portugal
Facility Name
Hospital de São João
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Hospital Joaquim Urbano
City
Porto
ZIP/Postal Code
4300
Country
Portugal
Facility Name
Hospital Distrital de Santarém
City
Santarém
ZIP/Postal Code
2000-153
Country
Portugal
Facility Name
Hospital de S. Bernardo
City
Setúbal
ZIP/Postal Code
2910
Country
Portugal
Facility Name
Hospital de S. Sebastião
City
Sta. Maria da Feira
ZIP/Postal Code
4520-211
Country
Portugal
Facility Name
Hospital Rainha Santa Isabel
City
Torres Novas
ZIP/Postal Code
2354-909
Country
Portugal
Facility Name
Centro Hospitalar de V. N. de Gaia
City
V.N.Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Facility Name
Hospital de S. Teotónio
City
Viseu
ZIP/Postal Code
3504-509
Country
Portugal
Facility Name
Hospital Espírito Santo
City
Évora
ZIP/Postal Code
7000
Country
Portugal

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.282_U06-2124.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.282_literature.pdf
Description
Related Info

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

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