A strategy of bacterial eradication to prevent exacerbations of COPD in the frequent exacerbator phenotype population (GOAL study), a prospective randomized controlled pilot study

Phase 4

Withdrawn

• Conditions: chronic bronchitis; COPD; 10004018; 10006436

• Registration Number: NL-OMON50113
• Lead Sponsor: Amphia Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

- COPD patients, who were 18 years or older, hospitalized with an exacerbation
for
which they need to receive corticosteroids and antibiotic treatment.
- COPD patients with 1 or more exacerbations in the previous year before
admission
for which they received steroids and/or antibiotic treatment.
- FEV1 less than 80% of predicted, FEV1 to FVC ratio < 0.7 and a history of
smoking
- Procalcitonin value >0.25 µg/L or CRP value > 50 mg/L

Exclusion Criteria

- History of fluoroquinolon hypersensitivity or adverse reaction to inhaled
fluoroquinolones
- A history of other significant respiratory diseases (e.g. asthma, cystic
fibrosis), the
presence of bronchiectasis assessed by computed tomography (CT), pregnant or
lactating women, malignancy of any kind for which the subject received
treatment or was being monitored as part of follow up after treatment,

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>time to next exacerbation, mean number of exacerbations in 6 month follow-up</p><br>

Secondary Outcome Measures

Name	Time	Method
<p> Number of exacerbations<br /><br>- Number of hospital admissions in 6 months<br /><br>- Bacterial eradication measured by 3 different negative sputum cultures during<br /><br>6 months<br /><br>- Lung function: FEV1; FVC<br /><br>- Quality of life</p><br>