NCT00132860

Brief Summary

The purpose of the study is to investigate, in patients with moderate to severe chronic obstructive lung disease, whether intermittent antibiotic treatment leads to:

  • A slower rate of decline in forced expiratory volume in one second (FEV1);
  • A reduction in the frequency and severity of exacerbations;
  • Fewer hospital admissions for chronic obstructive pulmonary disease (COPD);
  • Lower mortality;
  • An improved quality of life as compared to a group of placebo treated patients.

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
800

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2001

Longer than P75 for phase_4

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

May 1, 2001

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2005

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

October 19, 2005

Status Verified

August 1, 2005

First QC Date

August 19, 2005

Last Update Submit

October 18, 2005

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • change in postbronchodilator FEV1

Secondary Outcomes (7)

  • number of hospital admissions and number of hospital days

  • mortality

  • quality of life

  • use of medication

  • prevalence of respiratory pathogens

  • +2 more secondary outcomes

Interventions

azithromycinDRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients above 50 years of age, with a current admission for exacerbation of COLD or at least one admission within the previous two years.
  • Current or ex-smoker
  • Postbronchodilator FEV1 \< 60% in stable condition (\> 4 weeks after hospitalisation)
  • \< 300 ml bronchodilator reversibility in FEV1

You may not qualify if:

  • Patients with end-stage COLD, who are not expected to survive for 3 years (typically bedridden patients being dyspnoeic in rest).
  • Patients with known other respiratory tract infection, e.g. tuberculosis or aspergillosis, in whom the intervention is known to be inefficient.
  • Patients with pulmonary malignancy
  • Patients with other pulmonary diseases than COLD.
  • Patients with immunodeficiency. However, COLD patients treated with steroids can be included.
  • Patients with known hereditary disposition to lung infections such as alfa-1-antitrypsin deficiency, cystic fibrosis or primary ciliary dyskinesia.
  • Patients receiving longterm antibiotic treatment ( e.g. recurrent cystitis).
  • Patients with known allergy or intolerance to azithromycin
  • Pregnant or breastfeeding women
  • Manifest heart, liver or renal insufficiency
  • Patients that, for reasons not stated above, are unlikely to be able to participate in a study period of 3 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000 C, Denmark

Location

Related Publications (2)

  • Sorensen AK, Holmgaard DB, Mygind LH, Johansen J, Pedersen C. Neutrophil-to-lymphocyte ratio, calprotectin and YKL-40 in patients with chronic obstructive pulmonary disease: correlations and 5-year mortality - a cohort study. J Inflamm (Lond). 2015 Mar 18;12:20. doi: 10.1186/s12950-015-0064-5. eCollection 2015.

    PMID: 25908927DERIVED

  • Holmgaard DB, Mygind LH, Titlestad IL, Madsen H, Pedersen SS, Johansen JS, Pedersen C. Plasma YKL-40 and all-cause mortality in patients with chronic obstructive pulmonary disease. BMC Pulm Med. 2013 Dec 30;13:77. doi: 10.1186/1471-2466-13-77.

    PMID: 24373580DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Svend S Pedersen

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 19, 2005

First Posted

August 22, 2005

Study Start

May 1, 2001

Study Completion

December 1, 2007

Last Updated

October 19, 2005

Record last verified: 2005-08

Locations

DK(1)