Cystic FibrosisNCT04923464
A Decentralized Study to Evaluate Physical Activity and Cough Frequency Using Wearable Technology in Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Vertex Pharmaceuticals Incorporated at 17 sites in 2 countries.
Trial summary
This study will evaluate the performance of wearable technology in cystic fibrosis (CF) participants taking commercial Elexacaftor (ELX)/Tezacaftor (TEZ)/Ivacaftor (IVA) utilizing a fully decentralized trial design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 51 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 30 Jun 2021to 20 Dec 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with CF taking commercial ELX/TEZ/IVA will be enrolled in the study.
Who may be able to join
- Forced expiratory volume in 1 second (FEV1) value greater than or equal to (≥) 30 percent predicted
- Participants with an approved CF transmembrane conductance regulator gene (CFTR) genotype according to respective regional labels
Who cannot join
- History of solid organ or hematological transplantation
- Non-ambulatory status
- Other protocol defined Inclusion/Exclusion criteria may apply
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
United States11 sites
Massachusetts General Hospital Cystic Fibrosis Center Clinical Rsearch Center
Boston, Massachusetts, 02114
National Jewish Health
Denver, Colorado, 80206
UW School of Medicine & Public Health
Madison, Wisconsin, 53792
Morristown Medical Center
Morristown, New Jersey, 07960
Yale New Haven Hospital
New Haven, Connecticut, 06510
Mount Sinai Beth Israel
New York, New York, 10003
Santiago Reyes, M.D.
Oklahoma City, Oklahoma, 73112
Central Florida Pulmonary Group, P.A.
Orlando, Florida, 32803
Children's Hospital of Illinois at OSF Saint Francis Medical Center, Cystic Fibrosis Center
Peoria, Illinois, 61637
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Washington University School of Medicine
St Louis, Missouri, 63110
United Kingdom6 sites
Birmingham Heartlands Hospital
Birmingham
Royal Devon and Exeter Hospital
Exeter
St. James University Hospital
Leeds
Royal Brompton & Harefield NHS Foundation Trust, Royal Brompton Hospital
London
Wythenshawe Hospital
Manchester
Southampton General Hospital
Southampton
About this study
Official title: A Phase 4 Decentralized Pilot Study With Wearable Technology in Cystic Fibrosis Subjects 18 Years of Age and Older Taking Commercial Elexacaftor/Tezacaftor/Ivacaftor
This study will evaluate the performance of wearable technology in cystic fibrosis (CF) participants taking commercial Elexacaftor (ELX)/Tezacaftor (TEZ)/Ivacaftor (IVA) utilizing a fully decentralized trial design.
- Conditions
- Cystic Fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ELX/TEZ/IVA | CF participants who are currently on a stable regimen of commercially available ELX/TEZ/IVA will be evaluated for the performance of wearable technology devices. Wearable devices include a wrist-worn actigraphy sensor and an ambulatory cough monitoring system. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance With Actigraphy Wearable Device Measured as Percentage of Time a Participant is Wearing the Actigraphy Wearable Device
Measured: From Day 1 up to Week 12
Secondary outcomes (9)
Compliance With Cough Measurement Device Measured as Percentage of Time a Participant is Wearing the Cough Measurement Device
Measured: From Day 1 up to Week 12
Number of Steps per day and Variability in Number of Steps per day Over Time
Number of steps will be reported as mean and variability will be reported as standard deviation (SD).
Measured: From Day 1 up to Week 12
Number of Coughs per day and Variability in Number of Coughs per day Over Time
Number of coughs will be reported as mean and variability will be reported as SD.
Measured: From Day 1 up to Week 12
Time Spent Above Sedentary Physical Activity per day and Variability in Time Spent Above Sedentary Physical Activity per day Over Time
Time spent above sedentary physical activity will be reported as mean and variability will be reported as SD.
Measured: From Day 1 up to Week 12
Time Spent in Moderate-to-Vigorous Physical Activity per day and Variability in Time Spent in Moderate-to-Vigorous Physical Activity per day Over Time
Time spent in moderate-to-vigorous physical activity will be reported as mean and variability will be reported as SD.
Measured: From Day 1 up to Week 12
Time Spent in Continuous Walking Bouts per day and Variability in Time Spent in Continuous Walking Bouts per day Over Time
Time spent in continuous walking bouts will be reported as mean and variability will be reported as SD.
Measured: From Day 1 up to Week 12
Total Activity Count per day and Variability in Total Activity Count per day Over Time
Total activity count will be reported as mean and variability will be reported as SD.
Measured: From Day 1 up to Week 12
Best 6-Minute Effort (B6ME) and Variability in B6ME Over Time
B6ME will be reported as mean and variability will be reported as SD.
Measured: From Day 1 up to Week 12
Sleep Efficiency and Variability in Sleep Efficiency Over Time
Sleep efficiency measurements will be performed using wearable technology which include a wrist-worn actigraphy sensor. Sleep efficiency will be reported as mean and variability will be reported as SD.
Measured: From Day 1 up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start30 Jun 2021
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe 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
- Prospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923464
- Sponsor's protocol ID
- VX20-445-118
- Status last verified
- Jan 2022
- First submitted
- 20 May 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Individual data sharing
- No: Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 4 Decentralized Pilot Study With Wearable Technology in Cystic Fibrosis Subjects 18 Years of Age and Older Taking Commercial Elexacaftor/Tezacaftor/Ivacaftor
- ClinicalTrials.gov ID
- NCT04923464
- Acronym / sponsor ID
- VX20-445-118
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 11 Jun 2021 (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.
This study will evaluate the performance of wearable technology in cystic fibrosis (CF) participants taking commercial Elexacaftor (ELX)/Tezacaftor (TEZ)/Ivacaftor (IVA) utilizing a fully decentralized trial design.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ELX/TEZ/IVA | – | –CF participants who are currently on a stable regimen of commercially available ELX/TEZ/IVA will be evaluated for the performance of wearable technology devices. Wearable devices include a wrist-worn actigraphy sensor and an ambulatory cough monitoring system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with CF taking commercial ELX/TEZ/IVA will be enrolled in the study.
Key inclusion criteria (2 listed)
- Forced expiratory volume in 1 second (FEV1) value greater than or equal to (≥) 30 percent predicted
- Participants with an approved CF transmembrane conductance regulator gene (CFTR) genotype according to respective regional labels
Key exclusion criteria (3 listed)
- History of solid organ or hematological transplantation
- Non-ambulatory status
- Other protocol defined Inclusion/Exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compliance With Actigraphy Wearable Device Measured as Percentage of Time a Participant is Wearing the Actigraphy Wearable Device
Time frame: From Day 1 up to Week 12
9 secondary outcomes
Compliance With Cough Measurement Device Measured as Percentage of Time a Participant is Wearing the Cough Measurement Device
Time frame: From Day 1 up to Week 12
Number of Steps per day and Variability in Number of Steps per day Over Time
Time frame: From Day 1 up to Week 12
Number of Coughs per day and Variability in Number of Coughs per day Over Time
Time frame: From Day 1 up to Week 12
Time Spent Above Sedentary Physical Activity per day and Variability in Time Spent Above Sedentary Physical Activity per day Over Time
Time frame: From Day 1 up to Week 12
Time Spent in Moderate-to-Vigorous Physical Activity per day and Variability in Time Spent in Moderate-to-Vigorous Physical Activity per day Over Time
Time frame: From Day 1 up to Week 12
Time Spent in Continuous Walking Bouts per day and Variability in Time Spent in Continuous Walking Bouts per day Over Time
Time frame: From Day 1 up to Week 12
Total Activity Count per day and Variability in Total Activity Count per day Over Time
Time frame: From Day 1 up to Week 12
Best 6-Minute Effort (B6ME) and Variability in B6ME Over Time
Time frame: From Day 1 up to Week 12
Sleep Efficiency and Variability in Sleep Efficiency Over Time
Time frame: From Day 1 up to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Individual participant dataSharing planned: No. Details on Vertex data sharing criteria and process for requesting access can be found at: https://www.vrtx.com/independent-research/clinical-trial-data-sharing
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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.
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Vertex Pharmaceuticals Incorporated at 17 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 2 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: finished, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compliance With Actigraphy Wearable Device Measured as Percentage of Time a Participant is Wearing the Actigraphy Wearable Device (time frame: From Day 1 up to Week 12). 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 19 Jan 2022.