NCT00159276

Brief Summary

To investigate a possible mechanism of the GR defect in patients with severe COPD by studying the effect of dexamethasone (Dex) on GR-GRE binding, expression of inflammatory and anti-inflammatory factors such as IL-6, IL-8, MKP-1, GILZ, SLPI production in sputum cells

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 Dec 2005

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withdrawn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

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2005

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

April 4, 2024

Status Verified

April 1, 2024

Enrollment Period

Same day

First QC Date

September 8, 2005

Last Update Submit

April 3, 2024

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Induced SputumPROCEDURE

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with moderate (stage II, GOLD) COPD or subjects who are healthy smokers or subjects who are non-smokers.
  • Written informed consent

You may not qualify if:

  • Current upper respiratory tract infections
  • Any significant disease or disorder (e.g. cardiovascular, pulmonary (other than asthma), gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subjects ability to participate in the study
  • Subjects not considered capable, as judged by the investigator, of following instructions of the study, e.g. because of a history of alcohol or drug abuse or any other reason

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

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Sergei A Kharitonov, MD PhD

    Imperial College London

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

December 1, 2005

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

April 4, 2024

Record last verified: 2024-04

Locations

GB(1)