search
Back to results

Prophylactic Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease (COLD)

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Unknown status
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
azithromycin
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • Odense University Hospital

Outcomes

Primary Outcome Measures

change in postbronchodilator FEV1

Secondary Outcome Measures

number of hospital admissions and number of hospital days
mortality
quality of life
use of medication
prevalence of respiratory pathogens
prevalence of macrolide resistance
inflammatory parameters

Full Information

First Posted
August 19, 2005
Last Updated
October 18, 2005
Sponsor
Odense University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00132860
Brief Title
Prophylactic Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease (COLD)
Official Title
Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease: A Prospective, Randomized, Double-Blind Placebo-Controlled Study of Intermittent, Prophylactic Antibiotic Treatment With Azithromycin
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Unknown status
Study Start Date
May 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Odense University Hospital

4. Oversight

5. Study Description

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.
Detailed Description
Study Population: Patients with moderate to severe chronic obstructive lung disease. Trial Phase: IV Study Design: Prospective, randomised, double-blind, placebo- controlled clinical trial. Study Medicine: Azithromycin. Drug Administration: Oral. Drug Dose: 500 mg once daily for 3 days every month. Duration of Treatment: 3 years Number of Evaluable Patients: 200 per treatment arm Number of Included Patients: 400 per treatment arm, 800 patients in total.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
800 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
azithromycin
Primary Outcome Measure Information:
Title
change in postbronchodilator FEV1
Secondary Outcome Measure Information:
Title
number of hospital admissions and number of hospital days
Title
mortality
Title
quality of life
Title
use of medication
Title
prevalence of respiratory pathogens
Title
prevalence of macrolide resistance
Title
inflammatory parameters

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Svend S Pedersen
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense
ZIP/Postal Code
5000 C
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
25908927
Citation
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.
Results Reference
derived
PubMed Identifier
24373580
Citation
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.
Results Reference
derived

Learn more about this trial

Prophylactic Antibiotic Treatment of Patients With Chronic Obstructive Lung Disease (COLD)

We'll reach out to this number within 24 hrs