NCT00325897

Brief Summary

The purpose of this study is to determine if long-term administration of a macrolide antibiotic will reduce worsening of symptoms among individuals with chronic obstructive pulmonary disease (COPD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,142

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

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

March 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 15, 2006

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

June 7, 2012

Completed
Last Updated

November 18, 2019

Status Verified

October 1, 2019

Enrollment Period

4.3 years

First QC Date

May 12, 2006

Results QC Date

August 18, 2011

Last Update Submit

October 30, 2019

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • Time Until First Occurrence of Acute Chronic Obstructive Pulmonary Disease (COPD) Exacerbation

    Time until first occurrence of acute Chronic Obstructive Pulmonary Disease (COPD) exacerbation. Acute exacerbations are defined as a "complex of respiratory symptoms (increase or new onset) of more than one of the following: cough, sputum, wheezing, dyspnea, or chest tightness with a duration of at least three days requiring treatment with antibiotics and/or systemic steroids "

    Measured monthly through 13 months

Secondary Outcomes (6)

  • Exacerbations/Patient Year

    Measured monthly until 13 months

  • Number of Emergency Department Visits as a Result of Acute Exacerbations

    Measured monthly for 12 months

  • Number of Hospital Admissions as a Result of Acute Exacerbations

    Measured monthly for 12 months

  • Change in Age-adjusted Hearing Threshold

    Baseline and 12 months

  • Incidence of Macrolide-resistant Bacterial Colonization of the Nasopharynx or Sputum

    Baseline

  • +1 more secondary outcomes

Study Arms (2)

Azithromycin, 250 mg

ACTIVE COMPARATOR

Macrolide Antibiotic (Azithromycin)

Drug: Macrolide Antibiotic (Azithromycin)

Placebo

PLACEBO COMPARATOR

Inactive

Drug: Placebo

Interventions

Macrolide Antibiotic (Azithromycin)DRUG

Azithromycin (daily capsule, 250 mg for 12 months)

Also known as: Zithromax, Zmax
Azithromycin, 250 mg
PlaceboDRUG

Placebo taken on a daily basis

Also known as: sugar pill
Placebo

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of at least moderate Chronic Obstructive Pulmonary Disease (COPD), as defined by the following Global Initiative for COPD (GOLD) criteria:
  • Post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio of less than 70%
  • Post-bronchodilator FEV1 less than 80% predicted, with or without chronic symptoms
  • Cigarette consumption of 10 pack-years or more (may or may not be active smokers)
  • Meets one or more of the following four conditions:
  • Current, or history of, supplemental O2 use
  • Received a course of systemic corticosteroids for respiratory problems within 1 year prior to study entry
  • Visited an emergency department for a COPD exacerbation within 1 year prior to study entry
  • Hospitalized for a COPD exacerbation within 1 year prior to study entry
  • Willing to make return visits
  • Available by telephone for duration of study
  • Minimum of 4 weeks from the most recent acute exacerbation (have not received a course of systemic corticosteroids, an increased dose of chronically administered systemic corticosteroids, and/or antibiotics for an acute exacerbation for a minimum of 4 weeks from the time of study entry)

You may not qualify if:

  • Diagnosis of asthma
  • Diagnosis other than COPD that results in the patient being either medically unstable, or having a predicted life expectancy less than 3 years
  • Special patient groups (i.e., prisoners, pregnant women, or institutionalized patients)
  • Women who are at risk of becoming pregnant during the study (pre-menopausal) and who refuse to use acceptable birth control (i.e., hormone-based oral or barrier contraceptive) for the duration of the study
  • History of hypersensitivity to any macrolide antibiotic
  • Taking any of the following medications:
  • Cisapride
  • Ergot derivatives
  • Pimozide
  • Disopyramide
  • Cyclosporin
  • Tacrolimus
  • Nelfinavir
  • Bromocriptine
  • Hexobarbital
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

University of California at San Francisco

San Francisco, California, 94143, United States

Location

Harbor-UCLA Research & Education Inst.

Torrance, California, 90502, United States

Location

Denver City-County Health/Hospitals Dept.

Denver, Colorado, 80262, United States

Location

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Minnesota Veterans Research Inst.

Minneapolis, Minnesota, 55440, United States

Location

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (9)

  • Camac ER, Voelker H, Criner GJ; COPD Clinical Research Network and the Canadian Institutes of Health Research. Impact of COPD exacerbations leading to hospitalization on general and disease-specific quality of life. Respir Med. 2021 Sep;186:106526. doi: 10.1016/j.rmed.2021.106526. Epub 2021 Jun 29.

    PMID: 34229290DERIVED

  • Leitao Filho FS, Ra SW, Mattman A, Schellenberg RS, Criner GJ, Woodruff PG, Lazarus SC, Albert R, Connett JE, Han MK, Martinez FJ, Leung JM, Paul Man SF, Aaron SD, Reed RM, Sin DD; Canadian Respiratory Research Network (CRRN). Serum IgG subclass levels and risk of exacerbations and hospitalizations in patients with COPD. Respir Res. 2018 Feb 14;19(1):30. doi: 10.1186/s12931-018-0733-z.

    PMID: 29444682DERIVED

  • Brown KE, Sin DD, Voelker H, Connett JE, Niewoehner DE, Kunisaki KM; COPD Clinical Research Network. Serum bilirubin and the risk of chronic obstructive pulmonary disease exacerbations. Respir Res. 2017 Oct 24;18(1):179. doi: 10.1186/s12931-017-0664-0.

    PMID: 29065885DERIVED

  • Wetherbee EE, Niewoehner DE, Sisson JH, Lindberg SM, Connett JE, Kunisaki KM. Self-reported alcohol intake and risk of acute exacerbations of chronic obstructive pulmonary disease: a prospective cohort study. Int J Chron Obstruct Pulmon Dis. 2015 Jul 20;10:1363-70. doi: 10.2147/COPD.S86572. eCollection 2015.

    PMID: 26229455DERIVED

  • Geiger-Brown J, Lindberg S, Krachman S, McEvoy CE, Criner GJ, Connett JE, Albert RK, Scharf SM. Self-reported sleep quality and acute exacerbations of chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2015 Feb 20;10:389-97. doi: 10.2147/COPD.S75840. eCollection 2015.

    PMID: 25759571DERIVED

  • Han MK, Tayob N, Murray S, Dransfield MT, Washko G, Scanlon PD, Criner GJ, Casaburi R, Connett J, Lazarus SC, Albert R, Woodruff P, Martinez FJ. Predictors of chronic obstructive pulmonary disease exacerbation reduction in response to daily azithromycin therapy. Am J Respir Crit Care Med. 2014 Jun 15;189(12):1503-8. doi: 10.1164/rccm.201402-0207OC.

    PMID: 24779680DERIVED

  • Albert RK, Connett J, Curtis JL, Martinez FJ, Han MK, Lazarus SC, Woodruff PG. Mannose-binding lectin deficiency and acute exacerbations of chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2012;7:767-77. doi: 10.2147/COPD.S33714. Epub 2012 Nov 23.

    PMID: 23226013DERIVED

  • Albert RK, Connett J, Bailey WC, Casaburi R, Cooper JA Jr, Criner GJ, Curtis JL, Dransfield MT, Han MK, Lazarus SC, Make B, Marchetti N, Martinez FJ, Madinger NE, McEvoy C, Niewoehner DE, Porsasz J, Price CS, Reilly J, Scanlon PD, Sciurba FC, Scharf SM, Washko GR, Woodruff PG, Anthonisen NR; COPD Clinical Research Network. Azithromycin for prevention of exacerbations of COPD. N Engl J Med. 2011 Aug 25;365(8):689-98. doi: 10.1056/NEJMoa1104623.

    PMID: 21864166DERIVED

  • Kunisaki KM, Niewoehner DE. Antibiotic prophylaxis for chronic obstructive pulmonary disease: resurrecting an old idea. Am J Respir Crit Care Med. 2008 Dec 1;178(11):1098-9. doi: 10.1164/rccm.200808-1315ED. No abstract available.

    PMID: 19023036DERIVED

Related Links

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

MacrolidesAzithromycinSugars

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

LactonesOrganic ChemicalsPolyketidesMacrocyclic CompoundsPolycyclic CompoundsErythromycinCarbohydrates

Results Point of Contact

Title
Dr. Richard Albert
Organization
Denver Health Medical Center
ralbert@dhha.org
303-436-6900

Study Officials

  • Richard K. Albert, MD

    Denver City-County Health/Hospitals Department

    PRINCIPAL INVESTIGATOR

  • William C. Bailey, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

  • Richard Casaburi, MD, PhD

    Harbor-UCLA Research & Education Institute

    PRINCIPAL INVESTIGATOR

  • John E. Connett, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

  • Gerard J. Criner, MD

    Temple University

    PRINCIPAL INVESTIGATOR

  • Stephen C. Lazarus, MD

    University of California at San Francisco

    PRINCIPAL INVESTIGATOR

  • Fernando J. Martinez, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Dennis E. Niewoehner, MD

    Minnesota Veterans Medical Research and Education Foundation

    PRINCIPAL INVESTIGATOR

  • John J. Reilly, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

  • Steven M. Scharf, MD, PhD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

  • Frank Sciurba, MD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2006

First Posted

May 15, 2006

Study Start

March 1, 2006

Primary Completion

June 1, 2010

Study Completion

July 1, 2010

Last Updated

November 18, 2019

Results First Posted

June 7, 2012

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

US(10)