Chronic obstructive pulmonary disease (COPD) - exacerbations MedDRA version: 16.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855 MedDRA version: 16.1 Level: LLT Classification code 10010953 Term: COPD exacerbation System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Ciprofloxacin
Product Name: Ciprofloxacin
Pharmaceutical Form: Capsule
INN or Proposed INN: Ciprofloxacin
CAS Number: 85721-
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Pre-existing diagnosis of COPD, which will be confirmed by post-bronchodilator FEV1/FVC ratio of =65 years) yes F.1.3.1 Number of subjects for this age range 130
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will not be enrolled in this study: - Patients with other clinically predominant chronic respiratory disease. Patients with other respiratory diagnoses may be enrolled if COPD is the predominant condition (in the judgment of the study doctor) and if the additional diagnosis will not affect the safety of the patient or validity of their results. - Intubated patients receiving invasive positive-pressure ventilation. Patients receiving non-invasive ventilation and/or oxygen therapy may be included if they otherwise fulfil the inclusion and exclusion criteria. - Patients with known hypersensitivity to ciprofloxacin or any of the excipients used in its manufacture or that of the matched placebo. - Patients on long term antibiotics for other conditions - Patients already retreated with antibiotics for the current exacerbation (i.e. between day -14 and the screening visit) - Patients who at the screening visit are too unwell for randomisation and/or fulfil one or more of the following criteria: 1) SaO2 200mmHg 3) Resting tachypnoea >28 breaths/minute 4) Resting tachycardia >120 beats/minute 5) Drowsy or confused 6) Clinical examination suggesting pneumonia or complications (e.g. parapneumonic effusion/empyema) 7) Further antibiotic treatment required in the judgment of the study doctor and therefore would be at risk if randomised to the placebo arm - Female patients who are pregnant or planning on becoming pregnant during the study, or are breastfeeding. - Clinically relevant previously measured abnormal laboratory values at the screening assessment that could interfere with the objectives of the trial or safety of the volunteer. - Patient taking clinically significant contraindicated medication, as per the SmPCs - Patients who are actively enrolled in another interventional clinical trial (i.e. taking another IMP). Patients enrolled in observational COPD research (e.g. the London COPD Cohort Study [a recruitment source for this study] or COPDMAP) may continue as long as a) this study does not adversely impact on the scientific validity of the other study, and b) simultaneous participation is not unduly onerous for the patient. See section 8.8. - Elderly patients (=80 years) on long-term (>6 weeks) systemic corticosteroids at a dose of =5mg/day prednisolone or equivalent [these patients have an increased risk of tendon rupture with ciprofloxacin]. - Patients with any other condition precluding enrolment in the trial, according to the assessment of the study doctor. This will be documented at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 90 days after study enrolment.; Main Objective: The principal research question is whether an extra course of antibiotics, given two weeks after an exacerbation (flare up) of chronic obstructive pulmonary disease, can prevent repeat exacerbations in those patients who have not fully recovered from the first exacerbation. ; Secondary Objective: Secondary objectives for this study will include: 1) Whether patients’ recovery from the first exacerbation is faster with the antibiotic treatment than with placebo 2) The effects of the antibiotic treatment, compared to placebo, on: - The number of side effects and adverse (untoward) events experienced by patients - The frequency (rate) of exacerbations during the 3-month study follow-up period - The total number of further antibiotic courses received during 90 day follow-up in patients - Whether patients are readmitted to hospital during the study period - Respiratory healthcare status, assessed using symptom questionnaires (St George's Respiratory Questionnaire [SGRQ] and COPD Assessment Test [CAT]) - Change in patients' lung function from study entry to 90 days - Change in inflammation (measured by blood tests for CRP, a blood marker of inflammation) from study entry to 90 days - Changes in bacterial resistance to ciprofloxacin - Change in the number of bacteria i ; Primary end point(s): The primary outcome will be to assess the effect of retreatment with ciprofloxacin, compared to placebo, on the time to onset of the next exacerbation (from the start of retreatment with the IMP and up to a maximum follow-up period of 90 days). Exacerbation will here be defined using either HCU or diary card definitions. The onset o | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Duration of (first) exacerbation recovery (from point of retreatment V1) based on diary card symptoms •Treatment-related adverse events •Exacerbation frequency (rate) during follow-up. •Total number of antibiotic courses received during 90 day follow-up •(Re)admission/re-attendance to hospital during 90 day follow-up •Changes in respiratory healthcare status, assessed using SGRQ and CATChange in lung function from study entry to 90 days •Change in CRP from study entry to 90 days •Changes in bacterial resistance to ciprofloxacin as assessed by standard culture and sensitivity methods at trial beginning and end (in those patients in whom sputum is spontaneously expectorated) •Change in bacterial load from trial beginning to end (in those patients in whom sputum is spontaneously expectorated) ;Timepoint(s) of evaluation of this end point: 90 days after study entry | — |
Countries
United Kingdom
Contacts
Public ContactNabila Youssouf
Imperial College London
Outcome results
None listed