NCT00274027

Brief Summary

To explore the mechanisms of dyspnea relief during exercise in patients with COPD following treatment with tiotropium bromide (Spiriva)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2001

Geographic Reach
1 country

1 active site

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

January 1, 2001

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2006

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

2.2 years

First QC Date

January 9, 2006

Last Update Submit

October 31, 2013

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • Borg dyspnea rating at a standardized exercise time (DyspneaSTD) during a constant work rate exercise challenge to symptom limitation at 75% maximal work capacity

    up to 7 weeks

Secondary Outcomes (4)

  • Endurance time

    up to 7 weeks

  • Borg leg discomfort

    up to 7 weeks

  • Qualitative aspects of dyspnea

    up to 7 weeks

  • Locus of sensory limitation

    7 weeks

Interventions

tiotropium bromideDRUG

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L 2V6, Canada

Location

Related Publications (1)

  • Travers J, Laveneziana P, Webb KA, Kesten S, O'Donnell DE. Effect of tiotropium bromide on the cardiovascular response to exercise in COPD. Respir Med. 2007 Sep;101(9):2017-24. doi: 10.1016/j.rmed.2007.03.008. Epub 2007 May 1.

    PMID: 17475459DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Boehringer Ingelheim Study Coordinator

    B.I. Canada Ltd.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 9, 2006

First Posted

January 10, 2006

Study Start

January 1, 2001

Primary Completion

March 1, 2003

Study Completion

March 1, 2003

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

CA(1)