NCT02755974

Brief Summary

The London COPD exacerbation (EXCEL) cohort builds on an established cohort started in 1995 and designed to study COPD exacerbations and their impact on health-status and disease progression.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress97%
Jan 2009Dec 2026

Study Start

First participant enrolled

January 1, 2009

Completed
7.3 years until next milestone

First Submitted

Initial submission to the registry

April 13, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 21, 2022

Status Verified

June 1, 2022

Enrollment Period

18 years

First QC Date

April 13, 2016

Last Update Submit

June 16, 2022

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • Annual exacerbation rate (number of exacerbations over a 12 month period)

    Definition of an exacerbation * The presence of 2 new symptoms (one of which must be major) for 2 consecutive days * Major symptoms: increased breathlessness (A), increased sputum colour (B1) or increased sputum amount (B2) * Minor symptoms: a cold (C), increased wheeze or chest tightness (D), Sore throat (E1), Increased cough (E2), Fever (F)

    12 months

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with COPD who are generally seen in outpatient clinic.

You may qualify if:

  • Forced Expiratory Volume in 1 sec (FEV1)/Forced Vital Capacity (FVC) ratio of \<0.70
  • Able and willing to give informed and written consent

You may not qualify if:

  • Patients with a history of asthma, bronchiectasis, carcinoma of the bronchus, or other significant respiratory disease were excluded.
  • Patients on Immunosuppressive medications or with active cancer
  • Long term steroid therapy
  • Age \<40 years at recruitment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart and Lung Institute, Imperial College

London, SW3 6LR, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Sputum, Urine, Bronchoscopy brushing and Lavage fluid, DNA

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

  • Jadwiga Wedzicha

    Imperial College London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jadwiga A Wedzicha, MD

CONTACT

2075947947j.wedzicha@imperial.ac.uk

Gavin C Donaldson, PhD

CONTACT

207 4947859gavin.donaldson@imperial.ac.uk

Study Design

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

Study Record Dates

First Submitted

April 13, 2016

First Posted

April 29, 2016

Study Start

January 1, 2009

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 21, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)