NCT00239408

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
311

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2002

Geographic Reach
1 country

33 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

1.3 years

First QC Date

October 14, 2005

Last Update Submit

October 31, 2013

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • Change in trough FEV1 after 12 weeks of treatment.

    week 12

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Interventions

Pulmonary function TestingDEVICE
tiotropium bromideDRUG

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Hospital Garcia de Orta

Almada, 2800-525 Almada, Portugal

Location

Hospital Fernando Fonseca

Amadora, 2720-276Amadora, Portugal

Location

Hospital Santo Espírito de Angra do Heroismo

Angra Do Heroismo - Açores, 9700-856, Portugal

Location

Hospital Infante D. Pedro

Aveiro, 3810, Portugal

Location

Unidade Funcional de Infecciologia

Barreiro, 2830-094, Portugal

Location

Hospital de S. Marcos

Braga, 4701-965, Portugal

Location

Hospitais da Universidade de Coimbra

Coimbra, 3000-075, Portugal

Location

Centro Hospitalar de Coimbra

Coimbra, 3040-853, Portugal

Location

Centro Hospitalar da Cova da Beira

Covilha, 6200, Portugal

Location

Hospital Espírito Santo

Evora, 7000, Portugal

Location

Hospital Distrital de Faro

Faro, 8000-386, Portugal

Location

Hospital Distrital da Figueira da Foz

Figueira da Foz Municipality, 3080-707, Portugal

Location

Centro Hospitalar do Funchal

Funchal, 9004-514, Portugal

Location

Hospital de Sousa Martins

Guarda, 6300-749, Portugal

Location

Hospital Senhora da Oliveira

Guimarães, 4810-055, Portugal

Location

Hospital Particular de Lisboa

Lisbon, 1069-142, Portugal

Location

Instituto Português de Oncologia Francisco Gentil

Lisbon, 1099-023, Portugal

Location

Hospital de Santa Marta - HCL

Lisbon, 1196-024, Portugal

Location

Hospital Egas Moniz

Lisbon, 1349-019, Portugal

Location

Hospital Santa Maria

Lisbon, 1649-035, Portugal

Location

Hospital Pulido Valente

Lisbon, 1769-001, Portugal

Location

Unidade Local de Saúde de Matosinhos

Matosinhos Municipality, 4454-509, Portugal

Location

Hospital Divino Espírito Santo

Ponta Delgada - Açores, 9500-370, Portugal

Location

Hospital Barlavento Algarvio

Portimão, 8500-338, Portugal

Location

Hospital Geral de Santo António

Porto, 4050-011, Portugal

Location

Hospital de São João

Porto, 4200-319, Portugal

Location

Hospital Joaquim Urbano

Porto, 4300, Portugal

Location

Hospital de S. Sebastião

Santa Maria da Feira, 4520-211, Portugal

Location

Hospital Distrital de Santarém

Santarém, 2000-153, Portugal

Location

Hospital de S. Bernardo

Setúbal, 2910, Portugal

Location

Hospital Rainha Santa Isabel

Torres Novas, 2354-909, Portugal

Location

Centro Hospitalar de V. N. de Gaia

V.N.Gaia, 4434-502, Portugal

Location

Hospital de S. Teotónio

Viseu, 3504-509, Portugal

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Respiratory Function TestsTiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory SystemDiagnostic Techniques and ProceduresDiagnosisScopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Boehringer Ingelheim Study Coordinator

    B.I. Portugal Lda

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 14, 2005

First Posted

October 17, 2005

Study Start

December 1, 2002

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

PT(33)