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Targeted Retreatment of COPD Exacerbations

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ClinicalTrials.gov Identifier: NCT02300220
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Ciprofloxacin Drug: Placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Targeted Retreatment of Incompletely Recovered COPD Exacerbations With Ciprofloxacin: a Double-blind, Randomised, Placebo-controlled, Multicentre Phase III Trial
Actual Study Start Date : June 2014
Actual Primary Completion Date : January 22, 2019
Actual Study Completion Date : January 22, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ciprofloxacin
500 mg, twice daily for 1 week (oral).
Drug: Ciprofloxacin
500 mg, twice daily for 1 week (oral)

Placebo Comparator: Placebo
one capsule, twice daily for 1 week.
Drug: Placebo
One capsule, twice daily for 1 week




Primary Outcome Measures :
  1. Time to the next COPD exacerbation [ Time Frame: 7 days of treatment ]
    The primary outcome will be the time to the next COPD exacerbation following targeted retreatment with the IMP or placebo.


Secondary Outcome Measures :
  1. Duration of the initial exacerbation [ Time Frame: 7 days of treatment ]
    Secondary endpoints will include duration of the initial exacerbation following targeted retreatment with the IMP or placebo.

  2. Adverse events [ Time Frame: 7 days of treatment ]
    Secondary endpoints will include adverse events following targeted retreatment with the IMP or placebo.

  3. changes in lung function and health status [ Time Frame: 7 days of treatment ]
    Secondary endpoints will include changes in lung function and health status following targeted retreatment with the IMP or placebo.

  4. Bacterial load and resistance [ Time Frame: 7 days of treatment ]
    Secondary endpoints will include bacterial load and resistance following targeted retreatment with the IMP or placebo.

  5. Hospital readmission [ Time Frame: 7 days of treatment ]
    Secondary endpoints will include hospital readmission following targeted retreatment with the IMP or placebo.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300220


Locations
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United Kingdom
Aintree University Hospital NHS Foundation Trust
Liverpool, United Kingdom, L9 7AL
St Georges University Hospitals NHS Foundation Trust
London, United Kingdom, SW17 0RE
Royal Brompton and Harefield Hospital NHS Foundation Trust
London, United Kingdom, SW36NP
St Mary's Hospital
London, United Kingdom, W2 1NY
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Wisia Wedzicha, Professor Imperial College London

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT02300220     History of Changes
Other Study ID Numbers: 14IC2031
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Imperial College London:
Chronic Obstructive Pulmonary Disease (COPD)

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors