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

Phase 4

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive

• Registration Number: NCT00239408
• Lead Sponsor: Boehringer Ingelheim

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.

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2004-04
• Study Completion: 2004-04
• Study First Submitted: 2005-10-14
• Study First Submitted QC: 2005-10-14
• Study First Posted: 2005-10-17
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 311

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in trough FEV1 after 12 weeks of treatment.	week 12

Secondary Outcome Measures

Name	Time	Method
Trough FEV1 at interim visit	week 6
Change in FVC at weeks 6 and 12	week 6, week 12
Use of rescue medication (daytime and night-time)	12 weeks
Assessment of COPD symptoms	week 0, week 6, week 12
The Physician's Global Evaluation at Visits 2 and 4	week 0, week 12
Pulse Rate	12 weeks
Quality of life questionnaire (EQ-5D) at Visits 2 and 4	week 0, week 12
Blood Pressure	12 weeks

Trial Locations

Locations (33)

Hospital Garcia de Orta; 🇵🇹 Almada, Portugal

Unidade Funcional de Infecciologia; 🇵🇹 Barreiro, Portugal

Hospital Distrital de Faro; 🇵🇹 Faro, Portugal

Hospital de S. Marcos; 🇵🇹 Braga, Portugal

Centro Hospitalar da Cova da Beira; 🇵🇹 Covilhã, Portugal

Hospital Fernando Fonseca; 🇵🇹 Amadora, Portugal

Hospital Infante D. Pedro; 🇵🇹 Aveiro, Portugal

Hospital Distrital da Figueira da Foz; 🇵🇹 Figueira da Foz, Portugal

Hospital Senhora da Oliveira; 🇵🇹 Guimarães, Portugal

Unidade Local de Saúde de Matosinhos; 🇵🇹 Matosinhos, Portugal

Centro Hospitalar de V. N. de Gaia; 🇵🇹 V.N.Gaia, Portugal

Hospital Divino Espírito Santo; 🇵🇹 Ponta Delgada - Açores, Portugal

Centro Hospitalar do Funchal; 🇵🇹 Funchal, Portugal

Hospital Pulido Valente; 🇵🇹 Lisboa, Portugal

Hospital Egas Moniz; 🇵🇹 Lisbon, Portugal

Hospital Santa Maria; 🇵🇹 Lisbon, Portugal

Hospital Santo Espírito de Angra do Heroismo; 🇵🇹 Angra do Heroismo - Açores, Portugal

Hospitais da Universidade de Coimbra; 🇵🇹 Coimbra, Portugal

Centro Hospitalar de Coimbra; 🇵🇹 Coimbra, Portugal

Hospital de Sousa Martins; 🇵🇹 Guarda, Portugal

Hospital Particular de Lisboa; 🇵🇹 Lisboa, Portugal

Instituto Português de Oncologia Francisco Gentil; 🇵🇹 Lisboa, Portugal

Hospital de Santa Marta - HCL; 🇵🇹 Lisboa, Portugal

Hospital Barlavento Algarvio; 🇵🇹 Portimão, Portugal

Hospital Distrital de Santarém; 🇵🇹 Santarém, Portugal

Hospital Geral de Santo António; 🇵🇹 Porto, Portugal

Hospital de São João; 🇵🇹 Porto, Portugal

Hospital Joaquim Urbano; 🇵🇹 Porto, Portugal

Hospital de S. Sebastião; 🇵🇹 Sta. Maria da Feira, Portugal

Hospital de S. Bernardo; 🇵🇹 Setúbal, Portugal

Hospital Rainha Santa Isabel; 🇵🇹 Torres Novas, Portugal

Hospital de S. Teotónio; 🇵🇹 Viseu, Portugal

Hospital Espírito Santo; 🇵🇹 Évora, Portugal