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

NCT00239408 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 311

Last updated 2013-11-01

No results posted yet for this study

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.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DEVICE

Pulmonary function Testing

DRUG

tiotropium bromide

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim Study Coordinator · B.I. Portugal Lda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-12-31
Primary Completion
2004-04-30
Completion
2004-04-30

Countries

  • Portugal

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00239408 on ClinicalTrials.gov