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Triple therapy under the microscope: does it transform cystic fibrosis care?

NCT ID NCT04602468

Disease control Sponsor: Royal College of Surgeons, Ireland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time

Summary

Researchers are observing how elexacaftor/tezacaftor/ivacaftor triple combination therapy affects people with cystic fibrosis in routine care. The study follows two groups: children aged 6 to 11 and people aged 12 and older. Over seven years, they measure lung function, inflammation, imaging, gut and liver health, quality of life, and adherence to treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
elexacaftor/tezacaftor/ivacaftor triple combination therapy
What this could lead to
If the therapy holds up in everyday settings, doctors could better tailor cystic fibrosis care and predict who benefits most across lung, gut, and liver health.
What could go wrong
This observational study cannot prove the drug causes any changes seen. Results may not apply to people who do not match the study groups, and real-world adherence and other treatments can muddy the picture.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

206 people

The number who actually took part.

Started

Sep 2020

Expected to finish

Jul 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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. Exclusion Criteria: 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.

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Conditions

The condition(s) this trial relates to.

cystic fibrosis cystic fibrosis-related liver disease Medication Adherence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adherence, medication Cystic fibrosis Cystic fibrosis gastrointestinal disease Cystic fibrosis in children Cystic fibrosis liver disease

Contacts and locations

Locations

  • Children's Health Ireland at Crumlin

    Dublin, Leinster, Ireland

  • Children's Health Ireland at Tallaght

    Tallaght, Ireland

  • Children's Health Ireland at Temple Street

    Dublin, Ireland

  • Royal Belfast Hospital for Sick Children

    Belfast, United Kingdom

  • Royal Brompton Hospital

    London, United Kingdom

  • St. Vincent's University Hospital

    Dublin, Ireland

  • University Hospital Limerick

    Limerick, Limerick, V94 F858, Ireland

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