A controlled clinical trial to evaluate a personalised treatment approach for the management of acute exacerbations (flare-ups) of chronic obstructive pulmonary disease (COPD)

Not Applicable

Suspended

• Conditions: Chronic obstructive pulmonary disease; Respiratory

• Registration Number: ISRCTN85620156
• Lead Sponsor: Manchester University NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-01
• Last Update Posted: 27 April 2020
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

1. Males or females aged > 40 years
2. With a smoking history of at least 10 pack-years
3. A previous clinical diagnosis of COPD
4. Presenting with a moderate or severe AECOPD
5. Not having received antibiotics or systemic steroids during the preceding two weeks.
6. Capable of giving an informed consent
7. Subjects who are willing to allow his/her general practitioner, to be notified of their participation in the study.
8. The study will define severe exacerbations as those requiring hospitalisation, based on NICE criteria and moderate as those requiring antibiotics and/or systemic steroids, but not hospitalisation, according to the judgement of the responsible clinician who will be unaware of procalcitonin and EOS levels (following NICE guidelines)

Exclusion Criteria

1. Patients who have already received antibiotics or systemic steroids during the 2 weeks preceding recruitment/randomisation to the TRACE-COPD study
2. Those presenting with decompensated type 2 respiratory failure, requiring non-invasive ventilation and those admitted to the intensive care unit upon presentation
3. Patients with a primary diagnosis of pneumonia
4. Patients with a current diagnosis of asthma
5. Patients with known immunodeficiencies, cystic fibrosis, active tuberculosis, clinically significant bronchiectasis, those receiving long-term antibiotics and those with life expectancy of less than a year
6. People not able or keen to provide an informed consent for the study
7. Female participants who are pregnant or lactating
8. Patients diagnosed with medullary thyroid carcinoma (as this secretes procalcitonin)
9. Participants in active clinical trials of investigational medicinal products (IMP) or people who participated in clinical trials of IMP during the preceding 6 months. We will not recruit patients participating in any trial on COPD exacerbations
10. Patients with known allergy or sensitivity to doxycycline or prednisolone or an absolute contra-indication to their use
11. Patients in active clinical trials of investigational medicinal products (IMP) or people who participated in clinical trials of IMP during the preceding 6 months
12. Patients participating in any trial on COPD exacerbtaions

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. The proportion of patients receiving antibiotics for the index exacerbation, evaluated between day 14-21<br> 2. The proportion of patients receiving systemic steroids for the index exacerbation, evaluated between day 14-21<br> 3. Acceptability of the intervention (qualitative data collected throughout the study and during focus group meetings with participants), recruitment and consent rate (evaluated at baseline)<br>