Cystic FibrosisPhase 4RECOVERNCT04602468
Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER)
A Phase 4 study testing Elexacaftor/Tezacaftor/Ivacaftor in people with Cystic Fibrosis and Cystic Fibrosis Liver Disease, run by Royal College of Surgeons, Ireland at 7 sites in 2 countries.
Trial summary
RECOVER is a prospective, multicenter observational study designed to measure the real world clinical effectiveness of elexacaftor/tezacaftor/ivacaftor (ETI) triple combination therapy in people with cystic fibrosis initially over a two year period, followed by a five year extension period. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis, Cystic Fibrosis Liver Disease, Cystic Fibrosis in Children
- What is being tested?
- Elexacaftor/Tezacaftor/Ivacaftor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 3 Sep 2020to 1 Jul 2029
- 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 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants may only be selected for inclusion in RECOVER if they have been independently determined by their treating physician to be suitable for treatment with ETI in compliance with the official marketing authorization and summary of product characteristics (SPC).
- The decision to include participants in the study is independent of decision to prescribe ETI.
- Participants will receive treatment only through prescription by their physician through usual clinical treatment pathways.
- Subjects on ETI In exceptional circumstances where baseline clinical data has been collected prior to the start of treatment either through clinical care or ethically approved research projects (including a cohort of subjects initially recruited to this study on the understanding that it was a non-regulated observational study) subjects already receiving ETI may be recruited to this study and undergo on-treatment visits. Any additional patient data can only be added with written informed consent from the patients/parents concerned.
- All subjects must have a signed informed consent form and/or signed assent form when appropriate, as determined by the subjects age and individual site and country standards.
- Male and female participants of childbearing potential must agree to adhere to contraception requirements as detailed in the local ETI SmPC and in line with the standard of care.
Who cannot join
- Patients not willing to comply with study procedures or assessments.
- Individuals on clinical trials of investigational CFTR modulators.
- Clinical instability at baseline assessments. Subjects undergoing an active exacerbation and at the beginning of their treatment should be excluded from the study as this is likely to skew the data.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Ireland5 sites
Children's Health Ireland at Crumlin
Dublin, Leinster
Children's Health Ireland at Temple Street
Dublin
St. Vincent's University Hospital
Dublin
University Hospital Limerick
Limerick, Limerick, V94 F858
Children's Health Ireland at Tallaght
Tallaght
United Kingdom2 sites
Royal Belfast Hospital for Sick Children
Belfast
Royal Brompton Hospital
London
About this study
RECOVER is a prospective, multicenter observational study designed to measure the real world clinical effectiveness of elexacaftor/tezacaftor/ivacaftor (ETI) triple combination therapy in people with cystic fibrosis initially over a two year period, followed by a five year extension period. Measured outcomes include measures of lung function, lung inflammation, lung imaging, abdominal symptoms, gut inflammation, liver function, pancreatic exocrine function, nasal inflammation, quality of life and adherence to therapy. The study will examine outcomes in two cohorts, children aged six to eleven years and children and adults aged twelve and above.
Read the detailed description
Our aim with RECOVER is to examine the clinical impact of ETI on key clinical outcomes in people with CF in a real-world setting. For this study, in addition to some of the more traditional ways of monitoring clinical outcomes in people with CF such a standard lung function, nutrition, exacerbations and liver disease, the investigators are proposing to include some novel outcome measures not typically used in clinical trials such as lung clearance index (LCI) and spirometry controlled chest CT.
By implementing an extensive study protocol that will include important outcomes in a number of areas of health in people with CF, and matching this to a comprehensive biosample collection plan, the investigators will have the power to gain important insight into how ETI works, and what impact it has on rescue of CFTR function in this group of people.
Data on the following outcomes will be collected during the study:
Lung Clearance Index Ultra-low dose, spirometry-controlled CT scanning Sweat Chloride Nasal Lavage (inflammatory markers and microbiome) Fraction of Exhaled Nitric Oxide (FeNO) Liver Ultrasound Liver examination (signs of liver disease) Sputum Collection (inflammatory markers and microbiome) Stool Collection (inflammation, microbiome, fecal elastase) Abdominal symptom questionnaire CFQ-R (quality of life) Adherence to treatment Height, weight, BMI Forced Expiratory volume in 1 second (FEV1) Microbiological culture of airway specimens (clinical laboratories at sites) Mental Health outcomes
The Lead Investigator is Paul McNally, with Prof. Jane Davies as Co-Lead Investigator. The study will operate in collaboration with our academic and clinical partners and the CF registries in Ireland and the UK. The study is supported by the European CF Society Clinical Trials Network (ECFS-CTN). The study is being run as a CTIMP in the UK clinical sites, as determined by the MHRA. In the Irish sites, the HPRA has determined this study to be an observational research study.
- Conditions
- Cystic Fibrosis, Cystic Fibrosis Liver Disease, Cystic Fibrosis in Children, Adherence, Medication, Cystic Fibrosis Gastrointestinal Disease
- Being tested
- Elexacaftor/Tezacaftor/Ivacaftor
- Medical subject headings
- Cystic Fibrosis, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elexacaftor/Tezacaftor/IvacaftorDrug
The intervention is the same for both study groups. In addition to all the assessments in the standard arm, the advanced arm subjects will undergo spirometry controlled CT, nasal lavage and sputum sample collection.
| Study group | Role | What they receive |
|---|---|---|
| Standard group | Other | The standard testing group will be available for both age cohorts with sites having a predefined recruitment cap for each testing group. The standard testing will involve the following assessments; sweat chloride, LCI, height/weight/BMI, FEV1, airway sampling (micro), FeNO, liver function testing, liver ultrasound, liver examination, stool collection, blood collection, abdominal symptom score, CFQ-R, pharmacy records medication pick up rate, adherence questionnaires, MEMs caps and antibiotic use. Receives: Drug: Elexacaftor/Tezacaftor/Ivacaftor |
| Advanced group | Other | In addition to all elements of the standard testing group, the advanced testing group will undergo: Ultra-low dose spirometry-controlled CT scanning, sputum collection and nasal lavage collection. This will be available for both age cohorts with sites having a predefined recruitment cap for each testing group. Receives: Drug: Elexacaftor/Tezacaftor/Ivacaftor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in LCI on treatment with ETI in children and adults with CF.
Measured using multiple breath washout (MBW)
Measured: 84 month period
Secondary outcomes (24)
The change in spirometry-controlled CT scores on treatment with ETI in children and adults with CF.
Spirometry controlled CT
Measured: 84 month period
Change in airway inflammation markers in children and adults with CF
Change in NE, SLPI and IL-8 (pg/ml) concentration sputum and nasal lavage
Measured: 84 month period
The change on gastrointestinal symptoms on treatment with ETI in children and adults with CF
Abdominal symptom questionnaire scores
Measured: 84 month period
To determine the effect of treatment with ETI on antibiotic treatment of pulmonary disease in children and adults with CF over a two-year period
Medication possession ratio (MPR)
Measured: 24 month period
To assess the impact of the introduction of ETI on adherence with overall medical treatments for CF
Medication Event Monitoring (MEM) caps
Measured: 24 month period
To determine the effect of treatment with TCM on CF liver disease in children and adults with CF
Ultrasound and liver function test
Measured: 84 month period
To assess the understanding of disease and experiences with ETI among children and adolescents with CF.
Qualitative Interviews and Drawings
Measured: Up to year 1
To determine the longitudinal changes in mental health outcomes associated with the use of TCM in children and adults with CF.
Patient Health Questionnaire - 9 (PHQ-9)
Measured: 60 month period
Rate of Forced Expiratory Volume in 1 second (FEV1) (L) change on ETI treatment
Measured: 86 months
Change in microbiology on treatment with ETI in children and adults
Microbiology from clinical swabs and samples
Measured: 86 months
Change in iron oxide (FeNO) in children and adults with CF
Measured with the Niox VERO device
Measured: 84 month period
The change in gut inflammation on treatment with ETI in children and adults with CF
Fecal sample - M2PK
Measured: 84 month period
The change of pancreatic function on treatment with ETI in children and adults with CF
Measured by use of pancreatic enzymes
Measured: 84 month period
To assess the understanding of disease and experiences with ETI among children and adolescents with CF.
Patient Health Questionnaire 9 (PHQ-9)-Modified for Adolescents
Measured: Up to year 1
To assess the understanding of disease and experiences with ETI among children and adolescents with CF.
Generalised Anxiety Disorder 7 (GAD-7)
Measured: Up to year 1
To determine the longitudinal changes in mental health outcomes associated with the use of TCM in children and adults with CF.
Generalized Anxiety Disorder -7 (GAD-7)
Measured: 60 month period
To determine the longitudinal changes in mental health outcomes associated with the use of TCM in children and adults with CF.
PROMIS Pediatric Anxiety Scale (Short Form - 8a)
Measured: 60 month period
To determine the longitudinal changes in mental health outcomes associated with the use of TCM in children and adults with CF.
Depressed Mood Scale (Short Form - 8a)
Measured: 60 month period
To determine the longitudinal changes in mental health outcomes associated with the use of TCM in children and adults with CF.
PROMIS Pediatric Cognitive Function Scale (Short Form 7a)
Measured: 60 month period
To determine the longitudinal changes in mental health outcomes associated with the use of TCM in children and adults with CF.
RECOVER Body image questionnaire
Measured: 60 month period
To assess the impact of the introduction of ETI on adherence with overall medical treatments for CF
Adherence questionnaires
Measured: 24 month period
To assess the impact of the introduction of ETI on adherence with overall medical treatments for CF
Medication possession ratio (MPR)
Measured: 24 month period
The change in gut inflammation on treatment with ETI in children and adults with CF
Fecal sample - fecal elastase
Measured: 84 month period
The change in gut inflammation on treatment with ETI in children and adults with CF
Fecal sample - calprotectin
Measured: 84 month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start3 Sep 2020
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- The decision to implement ETI treatment is made completely independently of the decision to enter the study. The investigators will follow the requirements of the local approved ETI SmPC for the patient management as detailed in the 'special warnings and precautions for use' (e.g. management of hepatic impairment, rash, ophthalmological monitoring, between others), and for the management of interaction with other medicinal products and other forms of interactions. The 12+ cohort will be enrolled first on the basis the drug will be approved for children aged 12 and over first. The 6-11 year cohort will only be enrolled when the license is extended to this age group, and treatment with ETI will only occur in the context of prescription by a physician in compliance with marketing authorization and the SPC.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London, University College Dublin, University of Limerick, Cystic Fibrosis Registry of Ireland, Erasmus Medical Center, Medizinische Hochschule Brandenburg Theodor Fontane, Teagasc, The Hospital for Sick Children, St. James's Hospital, Ireland, Amsterdam UMC, Children's Health Ireland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602468
- Sponsor's protocol ID
- RECOVER
- Acronym
- RECOVER
- Status last verified
- Aug 2026
- First submitted
- 20 Oct 2020
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
McNally P, Lester K, Stone G, Elnazir B, Williamson M, Cox D, Linnane B, Kirwan L, Rea D, O'Regan P, Semple T, Saunders C, Tiddens HAWM, McKone E, Davies JC; RECOVER Study Group. Improvement in Lung Clearance Index and Chest Computed Tomography Scores with Elexacaftor/Tezacaftor/Ivacaftor Treatment in People with Cystic Fibrosis Aged 12 Years and Older - The RECOVER Trial. Am J Respir Crit Care Med. 2023 Nov 1;208(9):917-929. doi: 10.1164/rccm.202308-1317OC.
PubMed 37703083
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER)
- ClinicalTrials.gov ID
- NCT04602468
- Acronym / sponsor ID
- RECOVER / RECOVER
- Conditions
- Cystic Fibrosis, Cystic Fibrosis Liver Disease, Cystic Fibrosis in Children, Adherence, Medication, Cystic Fibrosis Gastrointestinal Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- Imperial College London, University College Dublin, University of Limerick, Cystic Fibrosis Registry of Ireland, Erasmus Medical Center, Medizinische Hochschule Brandenburg Theodor Fontane, Teagasc, The Hospital for Sick Children, St. James's Hospital, Ireland, Amsterdam UMC, Children's Health Ireland
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 26 Oct 2020 (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.
RECOVER is a prospective, multicenter observational study designed to measure the real world clinical effectiveness of elexacaftor/tezacaftor/ivacaftor (ETI) triple combination therapy in people with cystic fibrosis initially over a two year period, followed by a five year extension period. Measured outcomes include measures of lung function, lung inflammation, lung imaging, abdominal symptoms, gut inflammation, liver function, pancreatic exocrine function, nasal inflammation, quality of life and adherence to therapy. The study will examine outcomes in two cohorts, children aged six to eleven years and children and adults aged twelve and above.
Detailed description
Our aim with RECOVER is to examine the clinical impact of ETI on key clinical outcomes in people with CF in a real-world setting. For this study, in addition to some of the more traditional ways of monitoring clinical outcomes in people with CF such a standard lung function, nutrition, exacerbations and liver disease, the investigators are proposing to include some novel outcome measures not typically used in clinical trials such as lung clearance index (LCI) and spirometry controlled chest CT.
By implementing an extensive study protocol that will include important outcomes in a number of areas of health in people with CF, and matching this to a comprehensive biosample collection plan, the investigators will have the power to gain important insight into how ETI works, and what impact it has on rescue of CFTR function in this group of people.
Data on the following outcomes will be collected during the study:
Lung Clearance Index Ultra-low dose, spirometry-controlled CT scanning Sweat Chloride Nasal Lavage (inflammatory markers and microbiome) Fraction of Exhaled Nitric Oxide (FeNO) Liver Ultrasound Liver examination (signs of liver disease) Sputum Collection (inflammatory markers and microbiome) Stool Collection (inflammation, microbiome, fecal elastase) Abdominal symptom questionnaire CFQ-R (quality of life) Adherence to treatment Height, weight, BMI Forced Expiratory volume in 1 second (FEV1) Microbiological culture of airway specimens (clinical laboratories at sites) Mental Health outcomes
The Lead Investigator is Paul McNally, with Prof. Jane Davies as Co-Lead Investigator. The study will operate in collaboration with our academic and clinical partners and the CF registries in Ireland and the UK. The study is supported by the European CF Society Clinical Trials Network (ECFS-CTN). The study is being run as a CTIMP in the UK clinical sites, as determined by the MHRA. In the Irish sites, the HPRA has determined this study to be an observational research study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The decision to implement ETI treatment is made completely independently of the decision to enter the study. The investigators will follow the requirements of the local approved ETI SmPC for the patient management as detailed in the 'special warnings and precautions for use' (e.g. management of hepatic impairment, rash, ophthalmological monitoring, between others), and for the management of interaction with other medicinal products and other forms of interactions. The 12+ cohort will be enrolled first on the basis the drug will be approved for children aged 12 and over first. The 6-11 year cohort will only be enrolled when the license is extended to this age group, and treatment with ETI will only occur in the context of prescription by a physician in compliance with marketing authorization and the SPC.
| Arm | Type | Receives |
|---|---|---|
| Standard group | Other | Drug: Elexacaftor/Tezacaftor/IvacaftorThe standard testing group will be available for both age cohorts with sites having a predefined recruitment cap for each testing group. The standard testing will involve the following assessments; sweat chloride, LCI, height/weight/BMI, FEV1, airway sampling (micro), FeNO, liver function testing, liver ultrasound, liver examination, stool collection, blood collection, abdominal symptom score, CFQ-R, pharmacy records medication pick up rate, adherence questionnaires, MEMs caps and antibiotic use. |
| Advanced group | Other | Drug: Elexacaftor/Tezacaftor/IvacaftorIn addition to all elements of the standard testing group, the advanced testing group will undergo: Ultra-low dose spirometry-controlled CT scanning, sputum collection and nasal lavage collection. This will be available for both age cohorts with sites having a predefined recruitment cap for each testing group. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Participants may only be selected for inclusion in RECOVER if they have been independently determined by their treating physician to be suitable for treatment with ETI in compliance with the official marketing authorization and summary of product characteristics (SPC).
- The decision to include participants in the study is independent of decision to prescribe ETI.
- Participants will receive treatment only through prescription by their physician through usual clinical treatment pathways.
- Subjects on ETI In exceptional circumstances where baseline clinical data has been collected prior to the start of treatment either through clinical care or ethically approved research projects (including a cohort of subjects initially recruited to this study on the understanding that it was a non-regulated observational study) subjects already receiving ETI may be recruited to this study and undergo on-treatment visits. Any additional patient data can only be added with written informed consent from the patients/parents concerned.
- All subjects must have a signed informed consent form and/or signed assent form when appropriate, as determined by the subjects age and individual site and country standards.
Key exclusion criteria (3 listed)
- Patients not willing to comply with study procedures or assessments.
- Individuals on clinical trials of investigational CFTR modulators.
- Clinical instability at baseline assessments. Subjects undergoing an active exacerbation and at the beginning of their treatment should be excluded from the study as this is likely to skew the data.
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 |
|---|---|---|
| Elexacaftor/Tezacaftor/IvacaftorThe intervention is the same for both study groups. In addition to all the assessments in the standard arm, the advanced arm subjects will undergo spirometry controlled CT, nasal lavage and sputum sample collection. | Drug | Advanced group, Standard group |
Primary outcome
Change in LCI on treatment with ETI in children and adults with CF.
Time frame: 84 month period
Measured using multiple breath washout (MBW)
24 secondary outcomes
The change in spirometry-controlled CT scores on treatment with ETI in children and adults with CF.
Time frame: 84 month period
Change in airway inflammation markers in children and adults with CF
Time frame: 84 month period
The change on gastrointestinal symptoms on treatment with ETI in children and adults with CF
Time frame: 84 month period
To determine the effect of treatment with ETI on antibiotic treatment of pulmonary disease in children and adults with CF over a two-year period
Time frame: 24 month period
To assess the impact of the introduction of ETI on adherence with overall medical treatments for CF
Time frame: 24 month period
To determine the effect of treatment with TCM on CF liver disease in children and adults with CF
Time frame: 84 month period
To assess the understanding of disease and experiences with ETI among children and adolescents with CF.
Time frame: Up to year 1
To determine the longitudinal changes in mental health outcomes associated with the use of TCM in children and adults with CF.
Time frame: 60 month period
Rate of Forced Expiratory Volume in 1 second (FEV1) (L) change on ETI treatment
Time frame: 86 months
Change in microbiology on treatment with ETI in children and adults
Time frame: 86 months
Change in iron oxide (FeNO) in children and adults with CF
Time frame: 84 month period
The change in gut inflammation on treatment with ETI in children and adults with CF
Time frame: 84 month period
The change of pancreatic function on treatment with ETI in children and adults with CF
Time frame: 84 month period
To assess the understanding of disease and experiences with ETI among children and adolescents with CF.
Time frame: Up to year 1
To assess the understanding of disease and experiences with ETI among children and adolescents with CF.
Time frame: Up to year 1
To determine the longitudinal changes in mental health outcomes associated with the use of TCM in children and adults with CF.
Time frame: 60 month period
To determine the longitudinal changes in mental health outcomes associated with the use of TCM in children and adults with CF.
Time frame: 60 month period
To determine the longitudinal changes in mental health outcomes associated with the use of TCM in children and adults with CF.
Time frame: 60 month period
To determine the longitudinal changes in mental health outcomes associated with the use of TCM in children and adults with CF.
Time frame: 60 month period
To determine the longitudinal changes in mental health outcomes associated with the use of TCM in children and adults with CF.
Time frame: 60 month period
To assess the impact of the introduction of ETI on adherence with overall medical treatments for CF
Time frame: 24 month period
To assess the impact of the introduction of ETI on adherence with overall medical treatments for CF
Time frame: 24 month period
The change in gut inflammation on treatment with ETI in children and adults with CF
Time frame: 84 month period
The change in gut inflammation on treatment with ETI in children and adults with CF
Time frame: 84 month period
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 9 Sep 2026.
- Derived from this study: PubMed 37703083McNally P, Lester K, Stone G, Elnazir B, Williamson M, Cox D, Linnane B, Kirwan L, Rea D, O'Regan P, Semple T, Saunders C, Tiddens HAWM, McKone E, Davies JC; RECOVER Study Group. Improvement in Lung Clearance Index and Chest Computed Tomography Scores with Elexacaftor/Tezacaftor/Ivacaftor Treatment in People with Cystic Fibrosis Aged 12 Years and Older - The RECOVER Trial. Am J Respir Crit Care Med. 2023 Nov 1;208(9):917-929. doi: 10.1164/rccm.202308-1317OC.
- RCOVER Study websiteLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Elexacaftor/Tezacaftor/Ivacaftor in people with Cystic Fibrosis and Cystic Fibrosis Liver Disease, run by Royal College of Surgeons, Ireland at 7 sites in 2 countries.
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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Ireland, 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. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in LCI on treatment with ETI in children and adults with CF. (time frame: 84 month period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04602468, which also lists 1 linked publication.
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 9 Sep 2026.