Chronic Obstructive Pulmonary DiseasePhase 4OPACENCT05772013
Optimising Azithromycin Prevention Treatment in COPD to Reduce Exacerbations
A Phase 4 study testing Azithromycin Pill in people with Chronic Obstructive Pulmonary Disease, run by Dr Ian B Wilkinson at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Azithromycin Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,311 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Mar 2024to Nov 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Known hypersensitivity to any of the trial drugs or excipients.
- 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.
- Known immunodeficiency requiring immunoglobulin/specific antibody therapy.
- Azithromycin prophylaxis prescribed for non-COPD condition.
- Active participation in COPD Clinical Trial of an Investigational Medicinal Product (CTIMP).
- Electrocardiograms (ECGs) will not be a trial assessment nor entry requirement.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Cambridge University Hospital NHS Trust, Addenbrookes Hospital
Cambridge, CB2 0QQ
Zehra Yilmaz, PhD, 01223256599 ext. 256599, zehra.yilmaz@nhs.net
Samuel Resendez, MSc, 01223 349 762 ext. 349762, Samuel.resendez@nhs.net
About this study
Official title: Optimising Azithromycin Prevention Treatment in COPD to Reduce Exacerbations (OPACE): A Double Blind Adaptive Design Pragmatic Phase IV Randomised Controlled Trial
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.
Read the detailed description
Background: Prophylactic azithromycin is recommended as a treatment to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in people with COPD at high risk of exacerbations. In clinical practice, there is much uncertainty in how to optimally use this valuable treatment in managing COPD. It is unknown whether azithromycin is effective beyond one-year of treatment; what happens when azithromycin is discontinued following a period of use; or temporarily discontinued over the summer when there are fewer exacerbations. Whether there are differences in treatment responsiveness between subgroups of people with COPD is also uncertain.
Aim: To evaluate the benefits and risks of complete or seasonal discontinuation of azithromycin chemoprophylaxis vs continued treatment in people with stable COPD at high risk of exacerbations and assess effects in participant subgroups.
Methods: Design: A randomised double-blinded, non-inferiority, adaptive-design pragmatic trial of 3 parallel arms (complete discontinuation, vs seasonal discontinuation vs continued azithromycin as standard of care), to test the strategy of discontinuation of prophylactic azithromycin in participants with stable COPD at high risk of exacerbations. Internal pilot to evaluate recruitment will run for 9 months from first participant first visit (FPFV).
Randomisation allocation will be 1:1:1. Adaptive design means a treatment arm can be dropped if futile at interim analysis, but remaining arms continue.
Setting: General Practitioner (GP) practices, specialist community clinics, hospitals.
Target population: Stable COPD participants prescribed azithromycin ≥3 months to reduce risk of COPD exacerbations.
Interventions assessed: Complete discontinuation of azithromycin (matched placebo), seasonal discontinuation (azithromycin October-March, matched placebo April-September), continued azithromycin (standard of care).
Trial duration and procedures: Median follow up will be 24 months. Participants will have up to 3 visits - baseline, 12 months, 24 months/end of trial, which may coincide with standard of care visits and be in-person or remote depending on participant's individual preference. Telephone follow-up will be conducted at 1 week, 3 months, 6 months, and 18 months. All participants will have active follow up until study end, even if primary endpoint met. If participants have 3 or more exacerbations/year they will be advised to stop their trial medication. Participants may restart regular azithromycin prescription after stopping trial medication if advised by their GP/specialist. Secondary outcomes will be collected over the entire trial period and therefore may include evaluation both on and off trial medication.
Outcome measures:
Primary endpoint: Time to first exacerbation (TTFE) necessitating additional treatment with antibiotics and/or corticosteroids.
Key secondary endpoints (collected over entire trial)
- Number/rate and severity of exacerbations, length of exacerbation-free status
- Health related quality of life measured by change in the EuroQol-5 dimension
- Symptoms (COPD assessment tool (CAT) score and cough)
- Side effects
- Mortality
- Cost effectiveness from National Health Service (NHS) perspective.
Sample size: 1311 participants (437 per arm). Assuming a median TTFE of 150 days and non-inferiority threshold of 30 days shorter, equates to the threshold on the hazard ratio scale of 1.25. Sample size is based on 90 percent power for two non-inferiority comparisons (seasonal and placebo compared with continuous as standard treatment), at 2.7 percent significance using a Cox proportional hazards model. Pre-specified factors for subgroup analysis include exacerbation history, forced expiratory volume at one second (FEV1 percentage) predicted, current/ex-smoking status, COPD Assessment Tool (CAT) score, age, blood eosinophils.
Conclusion:
This pragmatic, real world trial aims to answer the uncertainties regarding prophylactic azithromycin use in COPD.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Azithromycin Pill, Placebo
- Keywords
- COPD, Azithromycin, Chemoprophylaxis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin PillDrug
Participants will take azithromycin according to their standard of care prescription.
If the participant is on the seasonal azithromycin treatment arm, they will only take azithromycin during the winter months (October-March) followed by matched placebo (April-September).
PlaceboDrug
The placebo tablets will be matched in appearance, taste and smell to the azithromycin tablets.
| Study group | Role | What they receive |
|---|---|---|
| Continuous azithromycin | Active comparator | Participants in this arm will continue with their standard of care (i.e. continuous dose of azithromycin according to their standard prescription) throughout the trial. Receives: Drug: Azithromycin Pill |
| Seasonal azithromycin | Other | Azithromycin will be taken by participants during the autumn-winter (October - March).
Matched placebo will be taken by the participants in the spring-summer (April - September). Receives: Drug: Azithromycin Pill; Drug: Placebo |
| Complete Discontinuation of azithromycin | Placebo comparator | Participants will take continuous matched placebo throughout the trial. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
COPD exacerbation
Time to first COPD exacerbation.
Measured: Throughout the entire trial follow-up of 24 months
Secondary outcomes (11)
Number and rate of exacerbations
Number/rate of exacerbations (and differentiation by severity of exacerbations, i.e. requirement of hospitalisation)
Measured: Throughout the entire trial follow-up of 24 months
Exacerbation-free period
Duration of exacerbation-free status
Measured: Throughout the entire trial follow-up of 24 months
Treatment for respiratory indication
Antibiotics and/or corticosteroids use for respiratory indication
Measured: Throughout the entire trial follow-up of 24 months
CAT Score
Symptoms/impact: COPD Assessment Tool (CAT) score
Measured: Throughout the entire trial follow-up of 24 months
Cough visual analogue scale (VAS) score
The severity of the cough will be rated on a scale of 0 to 10, whereby 0 = no cough, 10 = worst cough
Measured: Throughout the entire trial follow-up of 24 months
Health status
Measured by change in quality of life questionnaire: A scale of 0-100 will be used, whereby 0 = Worst health imaginable, 100 = Best health imaginable
Measured: Throughout the entire trial follow-up of 24 months
Mortality
Mortality (all cause and specific)
Measured: Throughout the entire trial follow-up of 24 months
Healthcare utilisation
Details about the number of hospitalizations and primary care consultations will be recorded. There will be linkage with NHS England and equivalent services.
Measured: Throughout the entire trial follow-up of 24 months
Adverse events of special interest (AESI) and Serious Adverse Reactions (SARs)
AESI's include cardiovascular and hearing-defined as new prescription of hearing aids, liver function test (LFT) dysfunction). Serious adverse reactions (SARs) to be recorded as well.
Measured: Throughout the entire trial follow-up of 24 months
Sputum culture results
Sputum culture results will only be obtained if clinically indicated and sample via routine clinical care to local lab. Record if positive result (i.e. name of organism cultured only, not cfu/ml). If multiple sent, most recent one to trial visit should be used.
Measured: Throughout the entire trial follow-up of 24 months
Adherence to trial medication
Participants will be asked whether they have missed any doses of the trial medication, and if so, if they stopped taking it for longer than 2 weeks in duration and why. Participants will also be asked to return trial bottles and unused trial medication to the trial research team at their appointments.
Measured: Throughout the entire trial follow-up of 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start5 Mar 2024
- Primary completionJun 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,311 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr Ian B Wilkinson
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aberdeen, NHS Greater Glasgow and Clyde, University of East Anglia, Nottingham City Hospital, Swansea University, Newcastle University, University of Cambridge, NHS Sunderland Clinical Commissioning Group, Liverpool School of Tropical Medicine, Royal Brompton & Harefield NHS Foundation Trust, University College London Hospitals, Liverpool Heart and Chest Hospital NHS Foundation Trust, Imperial College London, Red Graphic, Eramol (UK) Ltd., WGK Clinical Services Ltd., Sealed Envelope Ltd., National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor-investigator, Dr Ian B Wilkinson, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Ian B Wilkinson, Study director, University of Cambridge & University of Cambridge NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772013
- Sponsor's protocol ID
- CCTU0333
- Acronym
- OPACE
- Status last verified
- Apr 2024
- First submitted
- 27 Feb 2023
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Azithromycin Prevention Treatment in COPD to Reduce Exacerbations (OPACE): A Double Blind Adaptive Design Pragmatic Phase IV Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05772013
- Acronym / sponsor ID
- OPACE / CCTU0333
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Azithromycin, Chemoprophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,311 participants (estimated)
- Lead sponsor
- Dr Ian B WilkinsonUniversity, hospital or other
- Collaborators
- University of Aberdeen, NHS Greater Glasgow and Clyde, University of East Anglia, Nottingham City Hospital, Swansea University, Newcastle University, University of Cambridge, NHS Sunderland Clinical Commissioning Group, Liverpool School of Tropical Medicine, Royal Brompton & Harefield NHS Foundation Trust, University College London Hospitals, Liverpool Heart and Chest Hospital NHS Foundation Trust, Imperial College London, Red Graphic, Eramol (UK) Ltd., WGK Clinical Services Ltd., Sealed Envelope Ltd., National Institute for Health Research, United Kingdom
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Prophylactic azithromycin is recommended as a treatment to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in people with COPD at high risk of exacerbations. In clinical practice, there is much uncertainty in how to optimally use this valuable treatment in managing COPD. It is unknown whether azithromycin is effective beyond one-year of treatment; what happens when azithromycin is discontinued following a period of use; or temporarily discontinued over the summer when there are fewer exacerbations. Whether there are differences in treatment responsiveness between subgroups of people with COPD is also uncertain.
Aim: To evaluate the benefits and risks of complete or seasonal discontinuation of azithromycin chemoprophylaxis vs continued treatment in people with stable COPD at high risk of exacerbations and assess effects in participant subgroups.
Methods: Design: A randomised double-blinded, non-inferiority, adaptive-design pragmatic trial of 3 parallel arms (complete discontinuation, vs seasonal discontinuation vs continued azithromycin as standard of care), to test the strategy of discontinuation of prophylactic azithromycin in participants with stable COPD at high risk of exacerbations. Internal pilot to evaluate recruitment will run for 9 months from first participant first visit (FPFV).
Randomisation allocation will be 1:1:1. Adaptive design means a treatment arm can be dropped if futile at interim analysis, but remaining arms continue.
Setting: General Practitioner (GP) practices, specialist community clinics, hospitals.
Target population: Stable COPD participants prescribed azithromycin ≥3 months to reduce risk of COPD exacerbations.
Interventions assessed: Complete discontinuation of azithromycin (matched placebo), seasonal discontinuation (azithromycin October-March, matched placebo April-September), continued azithromycin (standard of care).
Trial duration and procedures: Median follow up will be 24 months. Participants will have up to 3 visits - baseline, 12 months, 24 months/end of trial, which may coincide with standard of care visits and be in-person or remote depending on participant's individual preference. Telephone follow-up will be conducted at 1 week, 3 months, 6 months, and 18 months. All participants will have active follow up until study end, even if primary endpoint met. If participants have 3 or more exacerbations/year they will be advised to stop their trial medication. Participants may restart regular azithromycin prescription after stopping trial medication if advised by their GP/specialist. Secondary outcomes will be collected over the entire trial period and therefore may include evaluation both on and off trial medication.
Outcome measures:
Primary endpoint: Time to first exacerbation (TTFE) necessitating additional treatment with antibiotics and/or corticosteroids.
Key secondary endpoints (collected over entire trial)
- Number/rate and severity of exacerbations, length of exacerbation-free status
- Health related quality of life measured by change in the EuroQol-5 dimension
- Symptoms (COPD assessment tool (CAT) score and cough)
- Side effects
- Mortality
- Cost effectiveness from National Health Service (NHS) perspective.
Sample size: 1311 participants (437 per arm). Assuming a median TTFE of 150 days and non-inferiority threshold of 30 days shorter, equates to the threshold on the hazard ratio scale of 1.25. Sample size is based on 90 percent power for two non-inferiority comparisons (seasonal and placebo compared with continuous as standard treatment), at 2.7 percent significance using a Cox proportional hazards model. Pre-specified factors for subgroup analysis include exacerbation history, forced expiratory volume at one second (FEV1 percentage) predicted, current/ex-smoking status, COPD Assessment Tool (CAT) score, age, blood eosinophils.
Conclusion:
This pragmatic, real world trial aims to answer the uncertainties regarding prophylactic azithromycin use in COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous azithromycin | Active comparator | Drug: Azithromycin PillParticipants in this arm will continue with their standard of care (i.e. continuous dose of azithromycin according to their standard prescription) throughout the trial. |
| Seasonal azithromycin | Other | Drug: Azithromycin Pill, Drug: PlaceboAzithromycin will be taken by participants during the autumn-winter (October - March). Matched placebo will be taken by the participants in the spring-summer (April - September). |
| Complete Discontinuation of azithromycin | Placebo comparator | Drug: PlaceboParticipants will take continuous matched placebo throughout the trial. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Known hypersensitivity to any of the trial drugs or excipients.
- 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.
- Known immunodeficiency requiring immunoglobulin/specific antibody therapy.
- Azithromycin prophylaxis prescribed for non-COPD condition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin PillParticipants will take azithromycin according to their standard of care prescription. If the participant is on the seasonal azithromycin treatment arm, they will only take azithromycin during the winter months (October-March) followed by matched placebo (April-September). | Drug | Continuous azithromycin, Seasonal azithromycin |
| PlaceboThe placebo tablets will be matched in appearance, taste and smell to the azithromycin tablets. | Drug | Complete Discontinuation of azithromycin, Seasonal azithromycin |
Primary outcome
COPD exacerbation
Time frame: Throughout the entire trial follow-up of 24 months
Time to first COPD exacerbation.
11 secondary outcomes
Number and rate of exacerbations
Time frame: Throughout the entire trial follow-up of 24 months
Exacerbation-free period
Time frame: Throughout the entire trial follow-up of 24 months
Treatment for respiratory indication
Time frame: Throughout the entire trial follow-up of 24 months
CAT Score
Time frame: Throughout the entire trial follow-up of 24 months
Cough visual analogue scale (VAS) score
Time frame: Throughout the entire trial follow-up of 24 months
Health status
Time frame: Throughout the entire trial follow-up of 24 months
Mortality
Time frame: Throughout the entire trial follow-up of 24 months
Healthcare utilisation
Time frame: Throughout the entire trial follow-up of 24 months
Adverse events of special interest (AESI) and Serious Adverse Reactions (SARs)
Time frame: Throughout the entire trial follow-up of 24 months
Sputum culture results
Time frame: Throughout the entire trial follow-up of 24 months
Adherence to trial medication
Time frame: Throughout the entire trial follow-up of 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ian B Wilkinson study director
University of Cambridge & University of Cambridge NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Azithromycin Pill in people with Chronic Obstructive Pulmonary Disease, run by Dr Ian B Wilkinson at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zehra T Yilmaz (+44 (0)1223 256599 ext. 6599, zehra.yilmaz@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COPD exacerbation (time frame: Throughout the entire trial follow-up of 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.