NCT00655694

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a chronic disease characterized by progressive airflow obstruction, chronic cough and dyspnoea in advanced stages. We hope to develop a better understanding of lung disease. Information from these studies will only be used for research purposes, to help develop safer and more effective treatments for asthma and COPD.

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 Jan 2005

Typical duration 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withdrawn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

January 1, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2008

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

2.7 years

First QC Date

April 4, 2008

Last Update Submit

July 8, 2019

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

COPDsmokershealthy volunteers

Interventions

sputum, blood, urine, exhaled breath, lung functionPROCEDURE

Eligibility Criteria

Age35 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-smoking volunteer aged 40 -75 years (age matched to COPD patients)
  • Normal spirometry (FEV1/FVC ratio \>70% and FEV1\>80% predicted)
  • Current and/or ex-smokers with no less than 10 pack-year smoking history aged 40-75 years
  • % FEV1 \< 80% of predicted (the upper value is a postbronchodilator value)
  • FEV1/FVC \< 70%
  • Stable COPD (no chest infection requiring antibiotics and/ or oral steroids in the past 2 months)
  • Long-acting beta2-agonists and long-acting antimuscarinic bronchodilators need to be stopped at least 8 hours before the study visit
  • The subjects are able to give informed consent
  • Current smokers aged 40 -75 years (age matched to COPD patients)
  • Normal spirometry (normal FEV1/FVC ratio \>70% and FEV1\>80% predicted)
  • Subjects are able to give informed consent
  • Non-smoking asthma patients aged 40 -75 years (age matched to COPD patients)
  • Normal spirometry (normal FEV1/FVC ratio \>70% and FEV1\>80% predicted)
  • Subjects are able to give informed consent

You may not qualify if:

  • Chest infection that required treatment with antibiotics within the last 4 weeks
  • Subjects who have received research medication within the previous one month
  • Subjects unable to give informed consent
  • Bronchodilator reversibility \> 12%
  • Chest infection that required treatment with antibiotics within the last 4 weeks
  • Subjects who have received research medication within the previous one month
  • Subjects unable to give informed consent
  • Patients with significant co-morbidities including any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study as judged by the investigator
  • Any other respiratory disease, which is considered by the investigator to be clinically significant
  • Chest infection that required treatment with antibiotics within the last 4 weeks
  • Subjects who have received research medication within the previous one month
  • Subjects unable to give informed consent
  • Chest infection that required treatment with antibiotics within the last 4 weeks
  • Patients with significant co-morbidities as judged by the investigator
  • Subjects who have received research medication within the previous one month
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart and Lung Institute

London, SW3 6LY, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Blood Specimen CollectionUrinationVentilation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesUrinary Tract Physiological PhenomenaReproductive and Urinary Physiological PhenomenaEnvironment, ControlledEnvironmentEnvironment and Public Health

Study Officials

  • Sergei A Kharitonov, MD PhD

    National Heart and Lung Institute

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

April 4, 2008

First Posted

April 10, 2008

Study Start

January 1, 2005

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

July 10, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)