Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT02300220
Targeted Retreatment of COPD Exacerbations
A Phase 3 study testing Ciprofloxacin in people with Chronic Obstructive Pulmonary Disease (COPD), run by Imperial College London at 4 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Ciprofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 5 May 2014to 22 Jan 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Aintree University Hospital NHS Foundation Trust
Liverpool, L9 7AL
St Georges University Hospitals NHS Foundation Trust
London, SW17 0RE
Royal Brompton and Harefield Hospital NHS Foundation Trust
London, SW36NP
St Mary's Hospital
London, W2 1NY
About this study
Official title: Targeted Retreatment of Incompletely Recovered COPD Exacerbations With Ciprofloxacin: a Double-blind, Randomised, Placebo-controlled, Multicentre Phase III Trial
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.
Read the 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.
- Being tested
- Ciprofloxacin, Placebo
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofloxacinDrug
500 mg, twice daily for 1 week (oral)
PlaceboDrug
One capsule, twice daily for 1 week
| Study group | Role | What they receive |
|---|---|---|
| Ciprofloxacin | Active comparator | 500 mg, twice daily for 1 week (oral). Receives: Drug: Ciprofloxacin |
| Placebo | Placebo comparator | one capsule, twice daily for 1 week. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 90 days
Secondary outcomes (5)
Duration of the Initial Exacerbation
Secondary endpoints will include duration of the initial exacerbation following targeted retreatment with the IMP or placebo.
Measured: Up to 90 days
Number of Participants With Serious Non Fatal Adverse Events
Secondary endpoints will include adverse events following targeted retreatment with the IMP or placebo.
Measured: 7 days of treatment
Changes in Lung Function
Secondary endpoints will include changes from randomization to 90 days in FEV1.
Measured: Baseline and 90 days
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.
Measured: Up to 90 days
Hospital Readmission
Secondary endpoints will include hospital readmission following targeted retreatment with the IMP or placebo.
Measured: 90 days of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study start5 May 2014
- Primary completion22 Jan 2019
- Study completion22 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wisia Wedzicha, Professor, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300220
- Sponsor's protocol ID
- 14IC2031
- Other IDs
- 2012-002198-72
- Status last verified
- Feb 2021
- First submitted
- 20 Nov 2014
- Last updated
- 8 Mar 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32267724
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Retreatment of Incompletely Recovered COPD Exacerbations With Ciprofloxacin: a Double-blind, Randomised, Placebo-controlled, Multicentre Phase III Trial
- ClinicalTrials.gov ID
- NCT02300220
- Acronym / sponsor ID
- 14IC2031
- Keywords
- Chronic Obstructive Pulmonary Disease (COPD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 5 May 2014 (actual)
- Primary completion
- 22 Jan 2019 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Posted 8 Mar 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciprofloxacin | Active comparator | Drug: Ciprofloxacin500 mg, twice daily for 1 week (oral). |
| Placebo | Placebo comparator | Drug: Placeboone capsule, twice daily for 1 week. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ciprofloxacin500 mg, twice daily for 1 week (oral) | Drug | Ciprofloxacin |
| PlaceboOne capsule, twice daily for 1 week | Drug | Placebo |
Primary outcome
Time to the Next COPD Exacerbation
Time frame: Up to 90 days
The primary outcome will be the time to the next COPD exacerbation following targeted retreatment with the IMP or placebo, censored at 90 days.
5 secondary outcomes
Duration of the Initial Exacerbation
Time frame: Up to 90 days
Number of Participants With Serious Non Fatal Adverse Events
Time frame: 7 days of treatment
Changes in Lung Function
Time frame: Baseline and 90 days
Number of Participants Who Have Resistance Bacteria in the Sputum
Time frame: Up to 90 days
Hospital Readmission
Time frame: 90 days of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32267724Ritchie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wisia Wedzicha, Professor principal investigator
Imperial College London
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ciprofloxacin in people with Chronic Obstructive Pulmonary Disease (COPD), run by Imperial College London at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to the Next COPD Exacerbation (time frame: Up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02300220, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2021.