Targeted Retreatment of COPD Exacerbations
Information source: Imperial College London
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease (COPD)
Intervention: Ciprofloxacin (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Imperial College London Official(s) and/or principal investigator(s): Wisia Wedzicha, Professor, Principal Investigator, Affiliation: Imperial College London
Overall contact: Wisia Wedzicha, Professor, Phone: 0044207 59 47947, Email: j.wedzicha@imperial.ac.uk
Summary
This study investigates the effects of targeted re-treatment of patients who do not recover
from an exacerbation of COPD. Half of the patients will receive ciprofloxacin while the
other half will receive a placebo.
Clinical Details
Official title: Targeted Retreatment of Incompletely Recovered COPD Exacerbations With Ciprofloxacin: a Double-blind, Randomised, Placebo-controlled, Multicentre Phase III Trial
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Time to the next COPD exacerbation
Secondary outcome: Duration of the initial exacerbationAdverse events changes in lung function and health status Bacterial load and resistance Hospital readmission
Detailed description:
COPD is a long term lung condition where patients suffer recurrent symptom flare-ups, called
'exacerbations'. Patients who have lots of exacerbations have a worse quality of life,
poorer ability to breath, and may die earlier than those who don't. Previous research by our
group has shown that patients who have an exacerbation and have not completely recovered two
weeks after the start of treatment are more likely to suffer another one early than those
who completely recover.
This study aims to test whether we can prevent this early re-exacerbation by giving an extra
course of antibiotics, compared to a placebo. Patients who experience an exacerbation of
COPD and are treated with antibiotics will, two weeks after the start of their treatment, be
invited to attend a screening visit. Patients will be eligible for the study if they have
not fully recovered at this visit (i. e. if they either still have symptoms or if blood tests
show there is still inflammation present) and fulfil other diagnostic measures for COPD.
Patients will be allocated to the treatment groups at random, and if eligible will be
treated with a further 1 week of ciprofloxacin 500mg twice daily or a placebo.
Patients will then be followed up in the study for a further 3 months, and the primary study
outcome will be the time to the next exacerbation.
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Wisia Wedzicha, Professor, Phone: 0044207 59 47947, Email: j.wedzicha@imperial.ac.uk
Aintree University Hospital NHS Foundation Trust, Liverpool L9 7AL, United Kingdom; Recruiting Paul Walker, Dr, Phone: 0151 529 5880, Email: ppwalker@liverpool.ac.uk Ben Vlies, Dr, Phone: 0044151 529 5882, Email: benvlies@doctors.org.uk
Royal Brompton and Harefield Hospital NHS Foundation Trust, London SW36NP, United Kingdom; Recruiting Wisia Wedzicha, Professor, Phone: 00442075947947, Email: j.wedzicha@imperial.ac.uk Simon Brill, Dr, Phone: 00442075947771, Email: s.brill@imperial.ac.uk
Additional Information
Starting date: June 2014
Last updated: June 2, 2015
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