Cystic FibrosisTEMETINCT06184763
Evolution of the 6-minute Walk Test in Patients Treated With ELEXACAFTOR / TEZACAFTOR / IVACAFTOR
An observational study of Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The aim of the study is to identify a link between the new CFTR modulators and physical activity in cystic fibrosis patients. The triple combination of CFTR modulators (ELEXACAFTOR / TEZACAFTOR/ IVACAFTOR) has recently changed the management of cystic fibrosis. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- 6-minute walk test
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2023to 1 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cohort: cystic fibrosis patients followed in the respiratory diseases department of the Renee Sabran Hospital (approximately 100 patients)
Who may be able to join
- Patients aged ≥ 12 years with cystic fibrosis, heterozygous for the F508del mutation of the CFTR gene, treated with ELEXACAFTOR/ TEZACAFTOR/ IVACAFTOR.
- Patients followed in the respiratory diseases department of the Renee Sabran Hospital
- 6-minute walked test performed in the year preceding initiation of ELEXACAFTOR / TEZACAFTOR/ IVACAFTOR
- 6-minute walked test performed after treatment initiation (between the 3rd month and the 14th month)
- No opposition to participation
Who cannot join
- - Age < 12 years
- Pregnancy
- Discontinuation or reduction in dosage of ELEXACAFTOR/ TEZACAFTOR/ IVACAFTOR
- Patients objecting to the use of their data for research purposes
Trial locations and contacts
1 site in 1 country.
France1 site
Respiratory diseases department, Renee Sabran Hospital (Hospices civils de Lyon)
Giens, 83406
About this study
The aim of the study is to identify a link between the new CFTR modulators and physical activity in cystic fibrosis patients.
The triple combination of CFTR modulators (ELEXACAFTOR / TEZACAFTOR/ IVACAFTOR) has recently changed the management of cystic fibrosis.
Read more
This treatment has been shown to rapidly improve patients' respiratory function, with a gain in FEV1 at 1 month ranging from 10.4% to 13.6%. It also reduces the number of respiratory exacerbations and improves the nutritional status and quality of life of treated patients.
To date, there is limited data on the impact of these new therapies on physical activity. Few studies have investigated changes in exercise or physical activity parameters under ELEXACAFTOR / TEZACAFTOR/ IVACAFTOR.
The 6-minute walk test is a validated field test used routinely to assess the exercise capacity of patients with chronic respiratory diseases, including cystic fibrosis.
- Conditions
- Cystic Fibrosis
- Being tested
- 6-minute walk test
- Keywords
- cystic fibrosis, CFTR modulators, 6-minutes walk test, physical activity
- Medical subject headings
- Cystic Fibrosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-minute walk testOther
6-minute walk test in a 40-metre corridor. Included patients are used to performing this test, which is part of the standard care performed during patient follow-up, at least once a year.
Parameters collected during the test: distance walked, minimum SpO2, average SpO2, maximum heart rate, average heart rate, average heart rate over the last 2 minutes, dyspnea scale.
| Study group | Role | What they receive |
|---|---|---|
| ELEXACAFTOR/TEZACAFTOR/ IVACAFTOR treated patients | Patients ≥ 12 years old with cystic fibrosis followed at the Renee Sabran Hospital, heterozygous for the F508del mutation of the CFTR gene, treated with ELEXACAFTOR/ TEZACAFTOR/ IVACAFTOR.
Intervention: 6-minute walk test before and after starting treatment. Receives: Other: 6-minute walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
distance walked in the 6-minute walk test (metres)
Distance walked in the 6-minute walk test, compared before and after the introduction of ELEXACAFTOR/ TEZACAFTOR/ IVACAFTOR.
Measured: between the 3rd month and the 14th month post treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start1 Aug 2023
- Primary completion1 Nov 2023
- Study completion1 Nov 2024 (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.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184763
- Sponsor's protocol ID
- 23-5232
- Other IDs
- Easydore
- Acronym
- TEMETI
- Status last verified
- Dec 2023
- First submitted
- 15 Dec 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perrone J, Rabilloud M, Mely L. Change in the 6-min walk test among 71 patients with cystic fibrosis treated with elexacaftor/tezacaftor/ivacaftor. Respir Med. 2025 Aug;244:108178. doi: 10.1016/j.rmed.2025.108178. Epub 2025 May 23.
PubMed 40414317
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of the 6-minute Walk Test in Patients Treated With ELEXACAFTOR / TEZACAFTOR / IVACAFTOR
- ClinicalTrials.gov ID
- NCT06184763
- Acronym / sponsor ID
- TEMETI / 23-5232
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, CFTR modulators, 6-minutes walk test, physical activity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 28 Dec 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.
The aim of the study is to identify a link between the new CFTR modulators and physical activity in cystic fibrosis patients.
The triple combination of CFTR modulators (ELEXACAFTOR / TEZACAFTOR/ IVACAFTOR) has recently changed the management of cystic fibrosis.
This treatment has been shown to rapidly improve patients' respiratory function, with a gain in FEV1 at 1 month ranging from 10.4% to 13.6%. It also reduces the number of respiratory exacerbations and improves the nutritional status and quality of life of treated patients.
To date, there is limited data on the impact of these new therapies on physical activity. Few studies have investigated changes in exercise or physical activity parameters under ELEXACAFTOR / TEZACAFTOR/ IVACAFTOR.
The 6-minute walk test is a validated field test used routinely to assess the exercise capacity of patients with chronic respiratory diseases, including cystic fibrosis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ELEXACAFTOR/TEZACAFTOR/ IVACAFTOR treated patients | – | Other: 6-minute walk testPatients ≥ 12 years old with cystic fibrosis followed at the Renee Sabran Hospital, heterozygous for the F508del mutation of the CFTR gene, treated with ELEXACAFTOR/ TEZACAFTOR/ IVACAFTOR. Intervention: 6-minute walk test before and after starting treatment. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cohort: cystic fibrosis patients followed in the respiratory diseases department of the Renee Sabran Hospital (approximately 100 patients)
Key inclusion criteria (5 listed)
- Patients aged ≥ 12 years with cystic fibrosis, heterozygous for the F508del mutation of the CFTR gene, treated with ELEXACAFTOR/ TEZACAFTOR/ IVACAFTOR.
- Patients followed in the respiratory diseases department of the Renee Sabran Hospital
- 6-minute walked test performed in the year preceding initiation of ELEXACAFTOR / TEZACAFTOR/ IVACAFTOR
- 6-minute walked test performed after treatment initiation (between the 3rd month and the 14th month)
- No opposition to participation
Key exclusion criteria (4 listed)
- - Age < 12 years
- Pregnancy
- Discontinuation or reduction in dosage of ELEXACAFTOR/ TEZACAFTOR/ IVACAFTOR
- Patients objecting to the use of their data for research purposes
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 |
|---|---|---|
| 6-minute walk test6-minute walk test in a 40-metre corridor. Included patients are used to performing this test, which is part of the standard care performed during patient follow-up, at least once a year. Parameters collected during the test: distance walked, minimum SpO2, average SpO2, maximum heart rate, average heart rate, average heart rate over the last 2 minutes, dyspnea scale. | Other | ELEXACAFTOR/TEZACAFTOR/ IVACAFTOR treated patients |
Primary outcome
distance walked in the 6-minute walk test (metres)
Time frame: between the 3rd month and the 14th month post treatment initiation
Distance walked in the 6-minute walk test, compared before and after the introduction of ELEXACAFTOR/ TEZACAFTOR/ IVACAFTOR.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Derived from this study: PubMed 40414317Perrone J, Rabilloud M, Mely L. Change in the 6-min walk test among 71 patients with cystic fibrosis treated with elexacaftor/tezacaftor/ivacaftor. Respir Med. 2025 Aug;244:108178. doi: 10.1016/j.rmed.2025.108178. Epub 2025 May 23.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Hospices Civils de Lyon at 1 site in France.
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 4 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: status not confirmed, as of the sponsor's last update on 28 Dec 2023. 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 France. 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.
Are results available for this study?
Results are not available in the source record.
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?
distance walked in the 6-minute walk test (metres) (time frame: between the 3rd month and the 14th month post treatment initiation). 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 NCT06184763, 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 28 Dec 2023.