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Pulmonary Disease, Chronic ObstructivePhase 4NCT00239408

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

A Phase 4 study testing Pulmonary function Testing and tiotropium bromide in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 33 sites in Portugal.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Pulmonary function Testing and tiotropium bromide
Type of treatment
Medical device
How many people
311 participants
Where
33 sitesPortugal
Study dates
Dec 2002to Apr 2004
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

Portugal33 sites
  • Hospital Garcia de Orta

    Almada, 2800-525 Almada

  • Hospital Fernando Fonseca

    Amadora, 2720-276Amadora

  • Hospital Santo Espírito de Angra do Heroismo

    Angra Do Heroismo - Açores, 9700-856

  • Hospital Infante D. Pedro

    Aveiro, 3810

  • Unidade Funcional de Infecciologia

    Barreiro, 2830-094

  • Hospital de S. Marcos

    Braga, 4701-965

  • Hospitais da Universidade de Coimbra

    Coimbra, 3000-075

  • Centro Hospitalar de Coimbra

    Coimbra, 3040-853

  • Centro Hospitalar da Cova da Beira

    Covilha, 6200

  • Hospital Espírito Santo

    Evora, 7000

  • Hospital Distrital de Faro

    Faro, 8000-386

  • Hospital Distrital da Figueira da Foz

    Figueira da Foz Municipality, 3080-707

  • Centro Hospitalar do Funchal

    Funchal, 9004-514

  • Hospital de Sousa Martins

    Guarda, 6300-749

  • Hospital Senhora da Oliveira

    Guimarães, 4810-055

  • Hospital Particular de Lisboa

    Lisbon, 1069-142

  • Instituto Português de Oncologia Francisco Gentil

    Lisbon, 1099-023

  • Hospital de Santa Marta - HCL

    Lisbon, 1196-024

  • Hospital Egas Moniz

    Lisbon, 1349-019

  • Hospital Santa Maria

    Lisbon, 1649-035

  • Hospital Pulido Valente

    Lisbon, 1769-001

  • Unidade Local de Saúde de Matosinhos

    Matosinhos Municipality, 4454-509

  • Hospital Divino Espírito Santo

    Ponta Delgada - Açores, 9500-370

  • Hospital Barlavento Algarvio

    Portimão, 8500-338

  • Hospital Geral de Santo António

    Porto, 4050-011

  • Hospital de São João

    Porto, 4200-319

  • Hospital Joaquim Urbano

    Porto, 4300

  • Hospital de S. Sebastião

    Santa Maria da Feira, 4520-211

  • Hospital Distrital de Santarém

    Santarém, 2000-153

  • Hospital de S. Bernardo

    Setúbal, 2910

  • Hospital Rainha Santa Isabel

    Torres Novas, 2354-909

  • Centro Hospitalar de V. N. de Gaia

    V.N.Gaia, 4434-502

  • Hospital de S. Teotónio

    Viseu, 3504-509

Other trials in Portugal

About this study

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.

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.

Read the 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.

Being tested
Pulmonary function Testing, tiotropium bromide
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pulmonary function TestingDevice

  • tiotropium bromideDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in trough FEV1 after 12 weeks of treatment.

    Measured: week 12

Secondary outcomes (8)
  1. Trough FEV1 at interim visit

    Measured: week 6

  2. Change in FVC at weeks 6 and 12

    Measured: week 6, week 12

  3. Use of rescue medication (daytime and night-time)

    Measured: 12 weeks

  4. Assessment of COPD symptoms

    Measured: week 0, week 6, week 12

  5. The Physician's Global Evaluation at Visits 2 and 4

    Measured: week 0, week 12

  6. Quality of life questionnaire (EQ-5D) at Visits 2 and 4

    Measured: week 0, week 12

  7. Pulse Rate

    Measured: 12 weeks

  8. Blood Pressure

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2005 (estimated)
  2. Study startDec 2002
  3. Primary completionApr 2004
  4. Study completionApr 2004

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
311 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00239408
Sponsor's protocol ID
205.282
Status last verified
Oct 2013
First submitted
14 Oct 2005
Last updated
1 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pulmonary function Testing and tiotropium bromide in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 33 sites in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in trough FEV1 after 12 weeks of treatment. (time frame: week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2013; AzTrials last refreshed its copy on 8 Nov 2026.

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