Targeted Retreatment of COPD Exacerbations

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

Targeted Retreatment of Incompletely Recovered COPD Exacerbations With Ciprofloxacin: a Double-blind, Randomised, Placebo-controlled, Multicentre Phase III Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02300220
• Other study ID #: 14IC2031
• Secondary ID: 2012-002198-72
• Status: Completed
• Phase: Phase 3
• Start date: May 5, 2014
• Est. completion date: January 22, 2019

Study information

• Verified date: February 2021
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: January 22, 2019
• Est. primary completion date: January 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Ciprofloxacin
500 mg, twice daily for 1 week (oral)
• Placebo
One capsule, twice daily for 1 week

Locations

Country	Name	City	State
United Kingdom	Aintree University Hospital NHS Foundation Trust	Liverpool
United Kingdom	Royal Brompton and Harefield Hospital NHS Foundation Trust	London
United Kingdom	St Georges University Hospitals NHS Foundation Trust	London
United Kingdom	St Mary's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 90 days
Secondary	Duration of the Initial Exacerbation	Secondary endpoints will include duration of the initial exacerbation following targeted retreatment with the IMP or placebo.	Up to 90 days
Secondary	Number of Participants With Serious Non Fatal Adverse Events	Secondary endpoints will include adverse events following targeted retreatment with the IMP or placebo.	7 days of treatment
Secondary	Changes in Lung Function	Secondary endpoints will include changes from randomization to 90 days in FEV1.	Baseline and 90 days
Secondary	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.	Up to 90 days
Secondary	Hospital Readmission	Secondary endpoints will include hospital readmission following targeted retreatment with the IMP or placebo.	90 days of treatment