NCT00147667

Brief Summary

The purpose of this study is to determine whether long term treatment with oral erythromycin is effective in the treatment of subjects with Chronic Obstructive Pulmonary Disease (COPD) by reducing the number of exacerbations and the degree of airway inflammation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2004

Geographic Reach
1 country

1 active site

Status
unknown

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, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

September 7, 2005

Status Verified

March 1, 2004

First QC Date

September 2, 2005

Last Update Submit

September 2, 2005

Conditions

COPD

Keywords

COPDEXACERBATIONSAIRWAY INFLAMMATION

Outcome Measures

Primary Outcomes (2)

  • Exacerbation Frequency

  • Airway Inflammation

Secondary Outcomes (4)

  • Lung Function

  • Health Status

  • Exacerbation Recovery Time

  • Symptoms

Interventions

ErythromycinDRUG

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical Diagnosis of COPD
  • Clinically stable for 6 weeks
  • Able to Swallow Tablets

You may not qualify if:

  • Clinically significant respiratory disease other than COPD
  • Women of child bearing age
  • Patients receiving existing Medication which may interact adversely with trial drug
  • History of clinically significant liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Free Hospital

London, England, NW3 1PF, United Kingdom

Location

Related Publications (1)

  • Seemungal TA, Wilkinson TM, Hurst JR, Perera WR, Sapsford RJ, Wedzicha JA. Long-term erythromycin therapy is associated with decreased chronic obstructive pulmonary disease exacerbations. Am J Respir Crit Care Med. 2008 Dec 1;178(11):1139-47. doi: 10.1164/rccm.200801-145OC. Epub 2008 Aug 21.

    PMID: 18723437DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Erythromycin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Jadwiga A Wedzicha, MD

    Royal Free and University College Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

April 1, 2004

Study Completion

March 1, 2006

Last Updated

September 7, 2005

Record last verified: 2004-03

Locations

GB(1)