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Can a Triple-Drug combo help CF patients cough less and move more?

NCT ID NCT04969224

Disease control Sponsor: Vertex Pharmaceuticals Incorporated 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a combination drug (elexacaftor/tezacaftor/ivacaftor) in 82 people with cystic fibrosis aged 12 and older. Researchers used wearable devices to measure how much the drug reduced coughing and increased physical activity over 12 weeks. The goal was to see if the treatment improves everyday life beyond standard lung function tests.

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 (a combination pill)
What this could lead to
If successful, this could show that the drug helps people with cystic fibrosis cough less and be more active in daily life.
What could go wrong
This is a small, open-label study (no placebo), so results may not be definitive. The drug is already approved, but benefits on cough and activity are still being explored.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

82 people

The number who actually took part.

Started

Oct 2021

Finished

Jul 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

12 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.

Key Inclusion Criteria: * Forced expiratory volume in 1 second (FEV1) value ≥30% and ≤90% predicted * Heterozygous for CF transmembrane conductance regulator gene (CFTR) F508del mutation and a minimal function mutation (F/MF genotypes) Key Exclusion Criteria: * Clinically significant liver cirrhosis * Solid organ or hematological transplantation * Non-ambulatory status * Lung infection with organisms associated with a more rapid decline in pulmonary status Other protocol defined Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

cystic fibrosis

As listed by the trial registrant

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

Cystic fibrosis

Contacts and locations

Locations

  • Alfred Hospital

    Melbourne, VIC, Australia

  • Cliniques Universitaires de Bruxelles Hopital Erasme

    Brussels, Belgium

  • Corporacio Sanitaria Parc Tauli - Sabadell Hospital Universitari

    Sabadell, Spain

  • Hospital Universitari Vall d Hebron

    Barcelona, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, Spain

  • Institute for Respiratory Health

    Nedlands, Australia

  • Mater Adult Hospital

    South Brisbane, Australia

  • Queen Elizabeth II Health Sciences Center

    Halifax, Canada

  • Queensland Children's Hospital

    South Brisbane, Australia

  • Royal Adelaide Hospital

    Adelaide, Australia

  • Telethon Kids Institute

    Nedlands, Australia

  • The Prince Charles Hospital

    Chermside, Australia

  • The Royal Children's Hospital

    Parkville, VIC, Australia

  • Universitair Ziekenhuis Brussel - Campus Jette

    Brussels, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, Belgium

  • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

    Leuven, Belgium

  • University of Alberta Hospital, Edmonton Clinic

    Edmonton, Canada

  • University of Calgary Medical Clinic of the Foothills Medical Centre

    Calgary, Canada

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