Back to resultsTargeted Retreatment of COPD Exacerbations
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Ciprofloxacin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic Obstructive Pulmonary Disease (COPD)
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of COPD confirmed spirometrically at screening
- COPD exacerbation with treatment commenced 14 days prior to study enrolment and treated with 5-14 days of a non-quinolone antibiotic.
- 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.
- Age: ≥ 45 years of age at screening.
- Persistent symptoms and/or a CRP≥8mg/L when assessed 2 weeks after exacerbation onset
- Able to complete questionnaires for health status and symptoms and keep written diary cards
- Severity of disease: Patients with a measured FEV1<80% of predicted normal values at 2 weeks post exacerbation
- Able and willing to give signed and dated written informed consent to participate.
Exclusion Criteria:
- Other clinically predominant chronic respiratory disease.
- Intubated and receiving mechanical ventilation
- Patients with known hypersensitivity to the antibiotic under evaluation, to other quinolones or any excipients of the IMP/placebo.
- Patients with a prior history of tendonopathy or tendon rupture
- Elderly patients taking long term systemic corticosteroids
- Patients on long term antibiotics for other conditions
- Patient too unwell for randomisation, i.e. requiring retreatment in the judgment of the study doctor
- Female patients who are pregnant or planning on becoming pregnant during the study, or are breastfeeding.
- Patient taking clinically significant contraindicated medication as per the SmPC s, such as use of concomitant tizanidine or methotrexate.
Sites / Locations
- Aintree University Hospital NHS Foundation Trust
- St Georges University Hospitals NHS Foundation Trust
- Royal Brompton and Harefield Hospital NHS Foundation Trust
- St Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ciprofloxacin
Placebo
Arm Description
500 mg, twice daily for 1 week (oral).
one capsule, twice daily for 1 week.
Outcomes
Primary Outcome Measures
Time to the Next COPD Exacerbation
The primary outcome will be the time to the next COPD exacerbation following targeted retreatment with the IMP or placebo, censored at 90 days.
Secondary Outcome Measures
Duration of the Initial Exacerbation
Secondary endpoints will include duration of the initial exacerbation following targeted retreatment with the IMP or placebo.
Number of Participants With Serious Non Fatal Adverse Events
Secondary endpoints will include adverse events following targeted retreatment with the IMP or placebo.
Changes in Lung Function
Secondary endpoints will include changes from randomization to 90 days in FEV1.
Number of Participants Who Have Resistance Bacteria in the Sputum
Bacterial load and resistance Secondary endpoints will include resistance following targeted retreatment with the IMP or placebo.
Hospital Readmission
Secondary endpoints will include hospital readmission following targeted retreatment with the IMP or placebo.
Full Information
NCT ID
NCT02300220
First Posted
November 20, 2014
Last Updated
February 16, 2021
Sponsor
Imperial College London
1. Study Identification
Unique Protocol Identification Number
NCT02300220
Brief Title
Targeted Retreatment of COPD Exacerbations
Official Title
Targeted Retreatment of Incompletely Recovered COPD Exacerbations With Ciprofloxacin: a Double-blind, Randomised, Placebo-controlled, Multicentre Phase III Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 5, 2014 (Actual)
Primary Completion Date
January 22, 2019 (Actual)
Study Completion Date
January 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Chronic Obstructive Pulmonary Disease (COPD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
144 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ciprofloxacin
Arm Type
Active Comparator
Arm Description
500 mg, twice daily for 1 week (oral).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
one capsule, twice daily for 1 week.
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin
Intervention Description
500 mg, twice daily for 1 week (oral)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
One capsule, twice daily for 1 week
Primary Outcome Measure Information:
Title
Time to the Next COPD Exacerbation
Description
The primary outcome will be the time to the next COPD exacerbation following targeted retreatment with the IMP or placebo, censored at 90 days.
Time Frame
Up to 90 days
Secondary Outcome Measure Information:
Title
Duration of the Initial Exacerbation
Description
Secondary endpoints will include duration of the initial exacerbation following targeted retreatment with the IMP or placebo.
Time Frame
Up to 90 days
Title
Number of Participants With Serious Non Fatal Adverse Events
Description
Secondary endpoints will include adverse events following targeted retreatment with the IMP or placebo.
Time Frame
7 days of treatment
Title
Changes in Lung Function
Description
Secondary endpoints will include changes from randomization to 90 days in FEV1.
Time Frame
Baseline and 90 days
Title
Number of Participants Who Have Resistance Bacteria in the Sputum
Description
Bacterial load and resistance Secondary endpoints will include resistance following targeted retreatment with the IMP or placebo.
Time Frame
Up to 90 days
Title
Hospital Readmission
Description
Secondary endpoints will include hospital readmission following targeted retreatment with the IMP or placebo.
Time Frame
90 days of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of COPD confirmed spirometrically at screening
COPD exacerbation with treatment commenced 14 days prior to study enrolment and treated with 5-14 days of a non-quinolone antibiotic.
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.
Age: ≥ 45 years of age at screening.
Persistent symptoms and/or a CRP≥8mg/L when assessed 2 weeks after exacerbation onset
Able to complete questionnaires for health status and symptoms and keep written diary cards
Severity of disease: Patients with a measured FEV1<80% of predicted normal values at 2 weeks post exacerbation
Able and willing to give signed and dated written informed consent to participate.
Exclusion Criteria:
Other clinically predominant chronic respiratory disease.
Intubated and receiving mechanical ventilation
Patients with known hypersensitivity to the antibiotic under evaluation, to other quinolones or any excipients of the IMP/placebo.
Patients with a prior history of tendonopathy or tendon rupture
Elderly patients taking long term systemic corticosteroids
Patients on long term antibiotics for other conditions
Patient too unwell for randomisation, i.e. requiring retreatment in the judgment of the study doctor
Female patients who are pregnant or planning on becoming pregnant during the study, or are breastfeeding.
Patient taking clinically significant contraindicated medication as per the SmPC s, such as use of concomitant tizanidine or methotrexate.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wisia Wedzicha, Professor
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aintree University Hospital NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
St Georges University Hospitals NHS Foundation Trust
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
Facility Name
Royal Brompton and Harefield Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SW36NP
Country
United Kingdom
Facility Name
St Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32267724
Citation
Ritchie AI, Brill SE, Vlies BH, Finney LJ, Allinson JP, Alves-Moreira L, Wiseman DJ, Walker PP, Baker E, Elkin SL, Mallia P, Law M, Donaldson GC, Calverley PMA, Wedzicha JA. Targeted Retreatment of Incompletely Recovered Chronic Obstructive Pulmonary Disease Exacerbations with Ciprofloxacin. A Double-Blind, Randomized, Placebo-controlled, Multicenter, Phase III Clinical Trial. Am J Respir Crit Care Med. 2020 Aug 15;202(4):549-557. doi: 10.1164/rccm.201910-2058OC.
Results Reference
derived
Learn more about this trial
Targeted Retreatment of COPD Exacerbations
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