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.
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
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- 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.
Change in trough FEV1 after 12 weeks of treatment.
Measured: week 12
Secondary outcomes (8)
Trough FEV1 at interim visit
Measured: week 6
Change in FVC at weeks 6 and 12
Measured: week 6, week 12
Use of rescue medication (daytime and night-time)
Measured: 12 weeks
Assessment of COPD symptoms
Measured: week 0, week 6, week 12
The Physician's Global Evaluation at Visits 2 and 4
Measured: week 0, week 12
Quality of life questionnaire (EQ-5D) at Visits 2 and 4
Measured: week 0, week 12
Pulse Rate
Measured: 12 weeks
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.
- First posted17 Oct 2005 (estimated)
- Study startDec 2002
- Primary completionApr 2004
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, B.I. Portugal Lda
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00239408
- Acronym / sponsor ID
- 205.282
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Primary completion
- Apr 2004 (actual)
- Study completion
- Apr 2004
- First posted
- 17 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary function Testing | Device | – |
| tiotropium bromide | Drug | – |
Primary outcome
Change in trough FEV1 after 12 weeks of treatment.
Time frame: week 12
8 secondary outcomes
Trough FEV1 at interim visit
Time frame: week 6
Change in FVC at weeks 6 and 12
Time frame: week 6, week 12
Use of rescue medication (daytime and night-time)
Time frame: 12 weeks
Assessment of COPD symptoms
Time frame: week 0, week 6, week 12
The Physician's Global Evaluation at Visits 2 and 4
Time frame: week 0, week 12
Quality of life questionnaire (EQ-5D) at Visits 2 and 4
Time frame: week 0, week 12
Pulse Rate
Time frame: 12 weeks
Blood Pressure
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2013.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim Study Coordinator study chair
B.I. Portugal Lda
33 sites in 1 country: see every site and its status.
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.