NCT00405236

Brief Summary

Patients with COPD experience exacerbations that are a major cause of morbidity. Exacerbations are associated with increased airway and systemic inflammation and those experiencing frequent exacerbations demonstrate increased inflammation in the stable state. Tiotropium has been shown to reduce exacerbation frequency and it might be postulated that this is due to a reduction in inflammation. The study will compare airway inflammation and exacerbation frequency in patients with COPD on tiotropium or placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for phase_4 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Oct 2002

Typical duration for phase_4 chronic-obstructive-pulmonary-disease

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2005

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 27, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 29, 2006

Completed
Last Updated

November 29, 2006

Status Verified

November 1, 2006

First QC Date

November 27, 2006

Last Update Submit

November 27, 2006

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

inflammationexacerbations

Outcome Measures

Primary Outcomes (1)

  • sputum IL-6

Secondary Outcomes (7)

  • sputum IL-8

  • sputum MPO

  • serum IL-6

  • serum CRP

  • exacerbation frequency

  • +2 more secondary outcomes

Interventions

tiotropiumDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of COPD,
  • FEV1 \< 80% predicted,
  • minimum 10 pack year smoking history

You may not qualify if:

  • asthma,
  • atopic disease,
  • eosinophilia,
  • history of malignancy,
  • history of clinically significant pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Chest Hospital

London, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveInflammation

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

  • Jadwiga A Wedzicha, MD

    Academic Unit of Respiratory Medicine, Royal Free and University College Medical School

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 27, 2006

First Posted

November 29, 2006

Study Start

October 1, 2002

Study Completion

January 1, 2005

Last Updated

November 29, 2006

Record last verified: 2006-11

Locations

GB(1)