Targeted Retreatment of COPD Exacerbations

NCT02300220 | Completed Phase 3 Results

• 2 other identifiers: 14IC20312012-002198-72
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 4

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Duration of the Initial Exacerbation

  Up to 90 days

• Number of Participants With Serious Non Fatal Adverse Events

  7 days of treatment

• Changes in Lung Function

  Baseline and 90 days

• Number of Participants Who Have Resistance Bacteria in the Sputum

  Up to 90 days

• Hospital Readmission

  90 days of treatment

Study Arms (2)

Ciprofloxacin

ACTIVE COMPARATOR

500 mg, twice daily for 1 week (oral).

Drug: Ciprofloxacin

Placebo

PLACEBO COMPARATOR

one capsule, twice daily for 1 week.

Drug: Placebo

Interventions

Ciprofloxacin DRUG

500 mg, twice daily for 1 week (oral)

Ciprofloxacin

Placebo DRUG

One capsule, twice daily for 1 week

Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (4)

Aintree University Hospital NHS Foundation Trust

Liverpool, L9 7AL, United Kingdom

Location

St Georges University Hospitals NHS Foundation Trust

London, SW17 0RE, United Kingdom

Location

Royal Brompton and Harefield Hospital NHS Foundation Trust

London, SW36NP, United Kingdom

Location

St Mary's Hospital

London, W2 1NY, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32267724 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Professor Jadwiga Wedzicha
• Organization: Imperial College London

j.wedzicha@imperial.ac.uk

02075947947

Study Officials

• Wisia Wedzicha, Professor

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 24, 2014
• Study Start: May 5, 2014
• Primary Completion: January 22, 2019
• Study Completion: January 22, 2019
• Last Updated: March 8, 2021
• Results First Posted: March 8, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (4)