NCT01337661

Brief Summary

The purpose of this study is to observe how the inflammatory pathways differ in subjects with chronic obstructive pulmonary disease (COPD) during an acute exacerbation of COPD (AECOPD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2011

Shorter than P25 for all trials

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

April 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 19, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

August 28, 2012

Status Verified

August 1, 2012

Enrollment Period

9 months

First QC Date

April 13, 2011

Last Update Submit

August 27, 2012

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary DiseaseCOPDAcute Exacerbation of COPDAECOPD

Outcome Measures

Primary Outcomes (1)

  • Identification of how inflammatory pathways differ in COPD subjects

    Identify how inflammatory pathways differ in subjects with COPD during an acute exacerbation relative to when the disease is stable.

    6 weeks

Secondary Outcomes (1)

  • Biomarker Sample Repository

    6 weeks

Study Arms (1)

COPD subjects

Adult male and female subjects with COPD

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects referred to the hospital clinic with AECOPD

You may qualify if:

  • Physician-diagnosed acute exacerbations of chronic obstructive pulmonary disease
  • Current or ex-smoker with a tobacco history of 15 or more pack years
  • Females of childbearing potential must use birth control for the duration of the study.

You may not qualify if:

  • Evidence or history of clinically significant disease
  • Subjects with asthma
  • Subjects taking anti-leukotriene medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Dublin, 15, Ireland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, Endobronchial tissues and Bronchoalveolar (BAL) samples

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

  • Rene van der Merwe, MBChB, MFPM

    MedImmune Ltd

    STUDY DIRECTOR

  • Prof. Connor Burke

    BCF Diagnostics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2011

First Posted

April 19, 2011

Study Start

April 1, 2011

Primary Completion

January 1, 2012

Study Completion

February 1, 2012

Last Updated

August 28, 2012

Record last verified: 2012-08

Locations

IE(1)