NCT00180622

Brief Summary

The primary aim of this study is to exploit a difference between COPD patients, chronic smokers without COPD and healthy non-smoking subjects. This will help to assess the utility of inflammatory and oxidative markers in exhaled air and sputum and to compare them with the lung function, clinical parameters and computerised tomography (CT).

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2001

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

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

July 1, 2001

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

September 9, 2005

Last Update Submit

July 2, 2019

Conditions

Healthy Non-smokersCurrent SmokersCOPD Patients

Interventions

SpirometryPROCEDURE
Exhaled Nitric Oxide and Carbon MonoxidePROCEDURE
Exhaled Breath CondensatePROCEDURE
Induced SputumPROCEDURE
CT ScanPROCEDURE
Blood testPROCEDURE
St Georges QuestionnairePROCEDURE
BodypletysmographyPROCEDURE

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy non-smokers
  • FEV1 \>80% predicted
  • FEV1 reversibility of \<10% after inhaled (beta2-agonists
  • Current smokers
  • FEV1 no less than 80% predicted
  • FEV1 reversibility of \<10% after inhaled (beta2-agonists
  • Smoking history of \> 10 pack-years
  • Moderate COPD
  • FEV1 40-59% predicted
  • FEV1 reversibility of \<10% after inhaled (beta2-agonists
  • Smoking history of \> 10 pack-years\*\*
  • Severe COPD
  • FEV1 \<40% predicted
  • FEV1 reversibility of \<10% after inhaled (beta2-agonists
  • Smoking history of \> 10 pack-years

You may not qualify if:

  • FEV1 increases by 200 ml and 15% of the baseline value after inhaled (beta2-agonists
  • Asthma
  • unstable disease (FEV1 \<35% predicted) and/or current, or within the last 4 weeks, respiratory tract infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Section of Airway Disease, Asthma Lab, Imperial College London, Royal Brompton Hospital

London, SW3 6LY, United Kingdom

Location

MeSH Terms

Interventions

Carbon MonoxideHematologic Tests

Intervention Hierarchy (Ancestors)

Carbon Compounds, InorganicInorganic ChemicalsGasesOxidesOxygen CompoundsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Sergei A Kharitonov, MD PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR

  • Peter J Barnes, MA DM DSc FRCP

    Imperial College London

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

July 1, 2001

Primary Completion

July 1, 2002

Study Completion

July 1, 2002

Last Updated

July 5, 2019

Record last verified: 2019-07

Locations

GB(1)