Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT02300220
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of COPD confirmed spirometrically at screening
2. COPD exacerbation with treatment commenced 14 days prior to study enrolment and treated with 5-14 days of a non-quinolone antibiotic.
3. Exacerbation here will be defined as an episode of symptomatic worsening of COPD that was treated by the patient's attending clinician. Confirmation of the initial exacerbation diagnosis will be provided from the case notes, referral letter, or directly from the treating clinician, and will be documented in the CRF.
4. Age: ≥ 45 years of age at screening.
5. Persistent symptoms and/or a CRP≥8mg/L when assessed 2 weeks after exacerbation onset
6. Able to complete questionnaires for health status and symptoms and keep written diary cards
7. Severity of disease: Patients with a measured FEV1\<80% of predicted normal values at 2 weeks post exacerbation
8. Able and willing to give signed and dated written informed consent to participate.
Exclusion Criteria:
1. Other clinically predominant chronic respiratory disease.
2. Intubated and receiving mechanical ventilation
3. Patients with known hypersensitivity to the antibiotic under evaluation, to other quinolones or any excipients of the IMP/placebo.
4. Patients with a prior history of tendonopathy or tendon rupture
5. Elderly patients taking long term systemic corticosteroids
6. Patients on long term antibiotics for other conditions
7. Patient too unwell for randomisation, i.e. requiring retreatment in the judgment of the study doctor
8. Female patients who are pregnant or planning on becoming pregnant during the study, or are breastfeeding.
9. Patient taking clinically significant contraindicated medication as per the SmPC s, such as use of concomitant tizanidine or methotrexate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT02300220
Study Brief:
Protocol Section:
NCT02300220