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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-002198-72 | EudraCT Number |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofloxacin | Active Comparator | 500 mg, twice daily for 1 week (oral). |
|
| Placebo | Placebo Comparator | one capsule, twice daily for 1 week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofloxacin | Drug | 500 mg, twice daily for 1 week (oral) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of Participants With Serious Non Fatal Adverse Events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wisia Wedzicha, Professor | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aintree University Hospital NHS Foundation Trust | Liverpool | L9 7AL | United Kingdom | |||
| St Georges University Hospitals NHS Foundation Trust |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32267724 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ciproflaxacin | Retreatment with Ciproflaxacin |
| FG001 | Placebo | Retreatment with Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ciprofloxacin | 500 mg, twice daily for 1 week (oral). Ciprofloxacin: 500 mg, twice daily for 1 week (oral) |
| BG001 | Placebo | one capsule, twice daily for 1 week. Placebo: One capsule, twice daily for 1 week |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | days | Up to 90 days |
|
90 days + 1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ciprofloxacin | 500 mg, twice daily for 1 week (oral). Ciprofloxacin: 500 mg, twice daily for 1 week (oral) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oncology | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Jadwiga Wedzicha | Imperial College London | 02075947947 | j.wedzicha@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 20, 2015 | Nov 7, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 15, 2019 | Nov 7, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Placebo |
| Drug |
One capsule, twice daily for 1 week |
|
Secondary endpoints will include adverse events following targeted retreatment with the IMP or placebo.
| 7 days of treatment |
| Changes in Lung Function | Secondary endpoints will include changes from randomization to 90 days in FEV1. | 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. | Up to 90 days |
| Hospital Readmission | Secondary endpoints will include hospital readmission following targeted retreatment with the IMP or placebo. | 90 days of treatment |
| London |
| SW17 0RE |
| United Kingdom |
| Royal Brompton and Harefield Hospital NHS Foundation Trust | London | SW36NP | United Kingdom |
| St Mary's Hospital | London | W2 1NY | United Kingdom |
| Adverse Event |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Did not tolerate IMP |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Duration of the Initial Exacerbation | Secondary endpoints will include duration of the initial exacerbation following targeted retreatment with the IMP or placebo. | Missing participants data 16 for ciprofloxacin and 15 for placebo | Posted | Median | Inter-Quartile Range | days | 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. | Posted | Count of Participants | Participants | 7 days of treatment |
|
|
|
| Secondary | Changes in Lung Function | Secondary endpoints will include changes from randomization to 90 days in FEV1. | Only the participants who completed the study | Posted | Mean | Standard Deviation | litres | 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. | Lower participants number due to the number of patients with a pathogenic organism with newly acquired ciprofloxacin resistance, present in a sputum sample collected at 90 days | Posted | Count of Participants | Participants | Up to 90 days |
|
|
|
| Secondary | Hospital Readmission | Secondary endpoints will include hospital readmission following targeted retreatment with the IMP or placebo. | Data not collected | Posted | 90 days of treatment |
|
|
| 1 |
| 72 |
| 1 |
| 72 |
| 12 |
| 72 |
| EG001 | Placebo | one capsule, twice daily for 1 week. Placebo: One capsule, twice daily for 1 week | 1 | 72 | 9 | 72 | 8 | 72 |
| Cardiovascular | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Gastrointestinal | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Psychological | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Respiratory | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Abdominal Colic/Pain | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Pruritis/Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dry Mouth | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ankle Pain/Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |