NCT05772013RecruitingPhase 4
Optimising Azithromycin Prevention Treatment in COPD to Reduce Exacerbations
Optimising Azithromycin Prevention Treatment in COPD to Reduce Exacerbations (OPACE): A Double Blind Adaptive Design Pragmatic Phase IV Randomised Controlled Trial
Source: ClinicalTrials.gov · Last updated 3 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
People living with chronic obstructive pulmonary disease (COPD) may experience worsening of symptoms such as shortness of breath, cough and wheezing in addition to changes that may be expected for having COPD. The worsening of symptoms is called exacerbations or flare-ups and can be debilitating and frightening, requiring additional treatment, often with azithromycin. This is an antibiotic medicine that also has anti-inflammatory properties. It is prescribed as long-term prevention to reduce the risk of flare-ups. Some people may be affected by side effects from azithromycin. Antibiotic resistance is another concern, especially when using azithromycin for prevention rather than to treat active infection. It is currently unclear as to whether people should be advised to stop taking azithromycin once COPD has stabilised, or to stop it over the summer when fewer flare-ups happen. It is also not known if azithromycin is more effective in some people or more likely to cause side effects in others. Given these uncertainties, it is challenging to know how best to use azithromycin in managing COPD. Azithromycin is a valuable antibiotic, and should be prescribed where it has benefit but avoid unnecessary side effects and reduce the chances of bacteria becoming resistant to it. The purpose of this trial is to be able to gain results to answer these questions, and to establish the effects of stopping azithromycin in people whose COPD has stabilised, who have been taking it for at least 3 months. This trial will compare continuing azithromycin with stopping it completely, or stopping over the summer only, continuing over the winter. The investigators will compare the effects of these three treatments in the trial on flare-ups, symptoms and quality of life, and find out what factors may affect how individual participants respond to them.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1311 (estimated)
- First submitted
- 27 Feb 2023
- Start date
- 5 Mar 2024
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Dr Ian B Wilkinson
- Diseases
- COPD
- NCT number
- NCT05772013
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 1311
- From 5 Mar 2024 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known immunodeficiency requiring immunoglobulin/specific antibody therapy.
Other illness
- Known hypersensitivity to any of the trial drugs or excipients.
- Azithromycin prophylaxis prescribed for non-COPD condition.
Other
- Current breast feeding, pregnancy or planned pregnancy during the trial.
- Any medical history or clinically relevant abnormality that makes participant ineligible for inclusion because of a safety concern relating to continuing or discontinuing azithromycin or other considerations.
- Active participation in COPD Clinical Trial of an Investigational Medicinal Product (CTIMP).
- Electrocardiograms (ECGs) will not be a trial assessment nor entry requirement.
Who the study is looking for
- Be able and willing to provide informed consent.
- Have an established clinical diagnosis of COPD and be receiving prophylactic azithromycin for ≥ (at least) 3 months to reduce COPD exacerbations.
- Have a self-reported smoking history of ≥ (at least) 10 pack years.
- Be aged \>= 40 years.
- Have clinically stable COPD, i.e. no COPD exacerbation for at least 6 weeks.
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cambridge University Hospital NHS Trust, Addenbrookes Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.