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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239408
• Other study ID #: 205.282
• Status: Completed
• Phase: Phase 4
• First received: October 14, 2005
• Last updated: October 31, 2013
• Start date: December 2002
• Est. completion date: April 2004

Study information

• Verified date: October 2013
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: INFARMED
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Pulmonary function Testing

Drug:
• tiotropium bromide

Locations

Country	Name	City	State
Portugal	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	Centro Hospitalar de Coimbra	Coimbra
Portugal	Hospitais da Universidade de Coimbra	Coimbra
Portugal	Centro Hospitalar da Cova da Beira	Covilhã
Portugal	Hospital Espírito Santo	Évora
Portugal	Hospital Distrital de Faro	Faro
Portugal	Hospital Distrital da Figueira da Foz	Figueira da Foz
Portugal	Centro Hospitalar do Funchal	Funchal
Portugal	Hospital de Sousa Martins	Guarda
Portugal	Hospital Senhora da Oliveira	Guimarães
Portugal	Hospital de Santa Marta - HCL	Lisboa
Portugal	Hospital Particular de Lisboa	Lisboa
Portugal	Hospital Pulido Valente	Lisboa
Portugal	Instituto Português de Oncologia Francisco Gentil	Lisboa
Portugal	Hospital Egas Moniz	Lisbon
Portugal	Hospital Santa Maria	Lisbon
Portugal	Unidade Local de Saúde de Matosinhos	Matosinhos
Portugal	Hospital Divino Espírito Santo	Ponta Delgada - Açores
Portugal	Hospital Barlavento Algarvio	Portimão
Portugal	Hospital de São João	Porto
Portugal	Hospital Geral de Santo António	Porto
Portugal	Hospital Joaquim Urbano	Porto
Portugal	Hospital Distrital de Santarém	Santarém
Portugal	Hospital de S. Bernardo	Setúbal
Portugal	Hospital de S. Sebastião	Sta. Maria da Feira
Portugal	Hospital Rainha Santa Isabel	Torres Novas
Portugal	Centro Hospitalar de V. N. de Gaia	V.N.Gaia
Portugal	Hospital de S. Teotónio	Viseu

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in trough FEV1 after 12 weeks of treatment.		week 12	No
Secondary	Trough FEV1 at interim visit		week 6	No
Secondary	Change in FVC at weeks 6 and 12		week 6, week 12	No
Secondary	Use of rescue medication (daytime and night-time)		12 weeks	No
Secondary	Assessment of COPD symptoms		week 0, week 6, week 12	No
Secondary	The Physician's Global Evaluation at Visits 2 and 4		week 0, week 12	No
Secondary	Quality of life questionnaire (EQ-5D) at Visits 2 and 4		week 0, week 12	No
Secondary	Pulse Rate		12 weeks	No
Secondary	Blood Pressure		12 weeks	No

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