Clinical trial NCT00132860: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2005-08-22
Enrollment: 800
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: change in postbronchodilator FEV1
Secondary outcomes:
measure: number of hospital admissions and number of hospital days
measure: mortality
measure: quality of life
measure: use of medication
measure: prevalence of respiratory pathogens
measure: prevalence of macrolide resistance
measure: inflammatory parameters
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Svend S Pedersen
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.