Cystic FibrosisNCT07088614
Effectiveness of Respiratory Physiotherapy on Frequency of Exacerbations, Lung Function and Quality of Life After 6 Months in Children With Cystic Fibrosis
A study testing Remote respiratory physiotherapy in people with Cystic Fibrosis, run by University of Americas - Chili at 1 site in Chile.
Trial summary
Daily respiratory physiotherapy is a fundamental part of cystic fibrosis treatment, however, patients adherence is low. Thus, there is a need for studies that evaluate the impact of physiotherapy supervision in patients with cystic fibrosis (CF), with particular emphasis on the effectiveness of telemonitoring. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Remote respiratory physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChile
- Study dates
- 28 Oct 2022to 4 Jul 2023
- Phase
- Interventional
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with a diagnosis of cystic fibrosis aged 6 to 18 years.
- Patients admitted to the National Cystic Fibrosis Programme.
- Patients followed at the pulmonology outpatient clinic of Dr. Luis Calvo Mackenna Hospital.
Who cannot join
- Patients currently undergoing pulmonary rehabilitation.
- Patients undergoing lung transplantation.
- Patients with severe comorbidity affecting survival.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Dr. Luis Calvo Mackenna Children's Hospital
Santiago, Santiago Metropolitan, 8370000
About this study
Official title: Effectiveness of Remote Respiratory Physiotherapy Using a Digital Platform on the Frequency of Exacerbations, Lung Function and Quality of Life, Assessed Before and After 6 Months of Intervention, in Children Aged 6-18 Years With Cystic Fibrosis at Dr. Luis Calvo Mackenna Hospital: a Pre-experimental Study.
Daily respiratory physiotherapy is a fundamental part of cystic fibrosis treatment, however, patients adherence is low. Thus, there is a need for studies that evaluate the impact of physiotherapy supervision in patients with cystic fibrosis (CF), with particular emphasis on the effectiveness of telemonitoring. A quantitative, pre-experimental, single-centre study was designed involving the universe of patients with CF from Dr. Luis Calvo Mackenna Hospital to measure frequency of exacerbations, pulmonary function and quality of life, before and after remote respiratory physiotherapy intervention via videoconference platform for 6 months.
Read the detailed description
This study evaluated the effectiveness of remote respiratory physiotherapy delivered via a videoconferencing platform for children aged 6 to 18 years with cystic fibrosis, who were followed at Dr. Luis Calvo Mackenna Hospital. Cystic fibrosis is a chronic respiratory disease that requires interdisciplinary management from the time of diagnosis, with respiratory physiotherapy being a cornerstone of treatment. Despite its importance, adherence is often low, especially for home-based care. Therefore, the study aimed to determine whether remote supervision could improve key clinical outcomes such as exacerbation frequency, pulmonary function, and quality of life.
The study followed a quantitative, pre-experimental, single-center design, with a non-probabilistic convenience sample. Although the initial target sample size was 16, the final study population included 9 patients, all diagnosed through a sweat test and enrolled in the National Cystic Fibrosis Program. The intervention consisted of remote respiratory physiotherapy sessions, held three times per week for six months, led by a physiotherapist via videoconference. Each session included clinical assessment, airway clearance techniques, supervised use of inhaled medications, physical exercise, and general health education.
Outcomes were measured before and after the intervention. Primary outcomes included the frequency of respiratory exacerbations. Secondary outcomes were lung function (measured by FEV1 and FVC), health-related quality of life (assessed using the PedsQL™ questionnaire), exercise capacity (via the six-minute walk test), days of hospitalization and antibiotic use, treatment adherence, and adverse events. All measurements were performed by trained, blinded professionals according to established clinical standards.
Statistical analysis was conducted using STATA version 14.2. Data distribution was assessed to select appropriate tests: paired t-tests or Wilcoxon tests were used for continuous variables, and McNemar's test was applied to categorical variables. A significance level of 0.05 was used, and results were presented with 95% confidence intervals. All adverse events were documented, including their characteristics, resolution, severity, and potential relation to the intervention.
- Conditions
- Cystic Fibrosis
- Being tested
- Remote respiratory physiotherapy
- Keywords
- Cystic fibrosis, Physiotherapy, Telehealth, Telemedicine, Children
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote respiratory physiotherapyOther
Remote respiratory physiotherapy protocol supervised 3 times a week via digital video conferencing, based on Chilean national guidelines for cystic fibrosis.
Each 1-hour session (3×/week for 6 months) includes:
Evaluation: respiratory assessment, teaching and reinforcement of airway clearance techniques, inhaled medication use, physical activity, and adherence to non-physiotherapy care. Six checklists are used to guide and monitor weekly patient activities.
Respiratory physiotherapy: conducted on-screen by the patient or caregiver, guided remotely. Includes: short-acting bronchodilator (if indicated), 7% hypertonic saline nebulization (10 min), 5-min Flutter/Acapella, ELTGOL or ELPr (2×5 min), and assisted coughing.
Re-evaluation: reassessment with the initial checklist, Q\&A, and scheduling the next session.
Participants continue their usual hospital-based care and receive baseline and post-intervention measurements.
| Study group | Role | What they receive |
|---|---|---|
| Remote physiotherapy group | Experimental | Remote respiratory physiotherapy protocol supervised 3 times a week via digital video conference, based on Chilean national guidelines for cystic fibrosis.
Each 1-hour session (3×/week for 6 months) includes:
Evaluation: respiratory assessment, teaching and reinforcement of airway clearance techniques, inhaled medication use, physical activity, and adherence to non-physiotherapy care. Six checklists are used to guide and monitor weekly patient activities.
Respiratory physiotherapy: conducted on-screen by the patient or caregiver, guided remotely. Includes: short-acting bronchodilator (if indicated), 7% hypertonic saline nebulization (10 min), 5-min Flutter/Acapella, ELTGOL or ELPr (2×5 min), and assisted coughing.
Re-evaluation: reassessment with the initial checklist, Q\&A, and scheduling the next session.
Participants continue their usual hospital-based care and receive baseline and post-intervention measurements. Receives: Other: Remote respiratory physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exacerbations frequency
Frequency of respiratory exacerbations over six months expressed as proportion of subjects with <1 exacerbation, 1-2 exacerbations, or >2 exacerbations), using the medical record.
Measured: Frequency of respiratory exacerbations will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.
Secondary outcomes (9)
Health-related quality of life
Quality of life will be assessed using the PedsQL™ Generic Core Scales, a 23-item generic health-related quality of life questionnaire designed for healthy children and adolescents aged 2-18 years, as well as those with chronic health conditions. The PedsQL™ Young Child Report (ages 5-7), Child Report (8-12), Teen Report (13-18), and corresponding parent proxy reports will be used. The PedsQL™ evaluates four domains: physical, emotional, social, and school functioning, using a 5-point Likert scale, with scores ranging from 0 to 92, where lower scores indicate better health-related quality of life. The PedsQL™ is a valid and reliable instrument, with an internal consistency coefficient of 0.88, and has been used in studies of patients with cystic fibrosis.
Measured: Health-related quality of life will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.
FEV1
FEV1 as a percentage of predicted assessed by spirometry using a laboratory spirometer at Dr. Luis Calvo Mackenna Hospital, previously calibrated, following the American Thoracic Society/European Respiratory Society (ATS/ERS) clinical guidelines.
Measured: FEV1 will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.
Days of hospitalization
Days of hospitalization will be assessed using the medical record as number of days
Measured: Days of hospitalization will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.
Days on intravenous/oral antibiotic treatment for respiratory causes
Days on intravenous/oral antibiotic treatment for respiratory causes will be assessed in the last 6 months, using the medical record.
Measured: Days on intravenous/oral antibiotic treatment will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.
Exercise capacity
Exercise capacity will be assessed using the 6-Minute Walk Test (6MWT), a reliable and valid test to measure exercise tolerance in children with cystic fibrosis. During the test, oxygen saturation (SpO₂) and heart rate (HR) will be continuously monitored and recorded at the beginning and end of the test, using the patient's own pulse oximeter or one provided by the study. Dyspnea will be assessed using the modified Borg scale at the beginning and end of the test. The exercise capacity will be expressed as distance walked, in meters,
Measured: Exercise capacity will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.
Treatment adherence
Treatment adherence will be determined as the percentage of compliance with the intervention guidelines.
Measured: Treatment adherence will be assessed at the end of the study, i.e. six months after the beginning of the intervention.
Adverse events
The occurrence of adverse events will be assessed using the medical record.
Measured: The occurrence of adverse events will be assessed from the beginning of the intervention up to six months after the beginning of the intervention.
FVC
FVC as a percentage of predicted by spirometry using a laboratory spirometer at Dr. Luis Calvo Mackenna Hospital, previously calibrated, following the American Thoracic Society/European Respiratory Society (ATS/ERS) clinical guidelines.
Measured: FVC will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.
FEV1/FVC
FEV1/FVC as a percentage assessed by spirometry using a laboratory spirometer at Dr. Luis Calvo Mackenna Hospital, previously calibrated, following the American Thoracic Society/European Respiratory Society (ATS/ERS) clinical guidelines.
Measured: FEV1/FVC will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start28 Oct 2022
- Primary completion1 Jun 2023
- Study completion4 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pre-experimental design, single-center
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Americas - Chili
- Sponsor type
- University, hospital or other
- Collaborators
- Luis Calvo Mackenna Children´s Hospital
- Responsible party
- Principal investigator, Andrea Mendez, University of Americas - Chili
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088614
- Sponsor's protocol ID
- DI20/22
- Status last verified
- Jul 2025
- First submitted
- 11 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Because it has not been required by other researchers.
Publications
Lavie M, Vilozni D, Sokol G, Somech R, Szeinberg A, Efrati O. Hospital versus home treatment of respiratory exacerbations in cystic fibrosis. Med Sci Monit. 2011 Dec;17(12):CR698-703. doi: 10.12659/msm.882129.
PubMed 22129901Goodfellow NA, Hawwa AF, Reid AJ, Horne R, Shields MD, McElnay JC. Adherence to treatment in children and adolescents with cystic fibrosis: a cross-sectional, multi-method study investigating the influence of beliefs about treatment and parental depressive symptoms. BMC Pulm Med. 2015 Apr 26;15:43. doi: 10.1186/s12890-015-0038-7.
PubMed 25927329Thornton J, Elliott R, Tully MP, Dodd M, Webb AK. Long term clinical outcome of home and hospital intravenous antibiotic treatment in adults with cystic fibrosis. Thorax. 2004 Mar;59(3):242-6. doi: 10.1136/thx.2003.005876.
PubMed 14985563
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Remote Respiratory Physiotherapy Using a Digital Platform on the Frequency of Exacerbations, Lung Function and Quality of Life, Assessed Before and After 6 Months of Intervention, in Children Aged 6-18 Years With Cystic Fibrosis at Dr. Luis Calvo Mackenna Hospital: a Pre-experimental Study.
- ClinicalTrials.gov ID
- NCT07088614
- Acronym / sponsor ID
- DI20/22
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, Physiotherapy, Telehealth, Telemedicine, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of Americas - ChiliUniversity, hospital or other
- Collaborators
- Luis Calvo Mackenna Children´s Hospital
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 4 Jul 2023 (actual)
- First posted
- 28 Jul 2025 (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.
Daily respiratory physiotherapy is a fundamental part of cystic fibrosis treatment, however, patients adherence is low. Thus, there is a need for studies that evaluate the impact of physiotherapy supervision in patients with cystic fibrosis (CF), with particular emphasis on the effectiveness of telemonitoring. A quantitative, pre-experimental, single-centre study was designed involving the universe of patients with CF from Dr. Luis Calvo Mackenna Hospital to measure frequency of exacerbations, pulmonary function and quality of life, before and after remote respiratory physiotherapy intervention via videoconference platform for 6 months.
Detailed description
This study evaluated the effectiveness of remote respiratory physiotherapy delivered via a videoconferencing platform for children aged 6 to 18 years with cystic fibrosis, who were followed at Dr. Luis Calvo Mackenna Hospital. Cystic fibrosis is a chronic respiratory disease that requires interdisciplinary management from the time of diagnosis, with respiratory physiotherapy being a cornerstone of treatment. Despite its importance, adherence is often low, especially for home-based care. Therefore, the study aimed to determine whether remote supervision could improve key clinical outcomes such as exacerbation frequency, pulmonary function, and quality of life.
The study followed a quantitative, pre-experimental, single-center design, with a non-probabilistic convenience sample. Although the initial target sample size was 16, the final study population included 9 patients, all diagnosed through a sweat test and enrolled in the National Cystic Fibrosis Program. The intervention consisted of remote respiratory physiotherapy sessions, held three times per week for six months, led by a physiotherapist via videoconference. Each session included clinical assessment, airway clearance techniques, supervised use of inhaled medications, physical exercise, and general health education.
Outcomes were measured before and after the intervention. Primary outcomes included the frequency of respiratory exacerbations. Secondary outcomes were lung function (measured by FEV1 and FVC), health-related quality of life (assessed using the PedsQL™ questionnaire), exercise capacity (via the six-minute walk test), days of hospitalization and antibiotic use, treatment adherence, and adverse events. All measurements were performed by trained, blinded professionals according to established clinical standards.
Statistical analysis was conducted using STATA version 14.2. Data distribution was assessed to select appropriate tests: paired t-tests or Wilcoxon tests were used for continuous variables, and McNemar's test was applied to categorical variables. A significance level of 0.05 was used, and results were presented with 95% confidence intervals. All adverse events were documented, including their characteristics, resolution, severity, and potential relation to the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pre-experimental design, single-center
| Arm | Type | Receives |
|---|---|---|
| Remote physiotherapy group | Experimental | Other: Remote respiratory physiotherapyRemote respiratory physiotherapy protocol supervised 3 times a week via digital video conference, based on Chilean national guidelines for cystic fibrosis. Each 1-hour session (3×/week for 6 months) includes: Evaluation: respiratory assessment, teaching and reinforcement of airway clearance techniques, inhaled medication use, physical activity, and adherence to non-physiotherapy care. Six checklists are used to guide and monitor weekly patient activities. Respiratory physiotherapy: conducted on-screen by the patient or caregiver, guided remotely. Includes: short-acting bronchodilator (if indicated), 7% hypertonic saline nebulization (10 min), 5-min Flutter/Acapella, ELTGOL or ELPr (2×5 min), and assisted coughing. Re-evaluation: reassessment with the initial checklist, Q\&A, and scheduling the next session. Participants continue their usual hospital-based care and receive baseline and post-intervention measurements. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients with a diagnosis of cystic fibrosis aged 6 to 18 years.
- Patients admitted to the National Cystic Fibrosis Programme.
- Patients followed at the pulmonology outpatient clinic of Dr. Luis Calvo Mackenna Hospital.
Key exclusion criteria (3 listed)
- Patients currently undergoing pulmonary rehabilitation.
- Patients undergoing lung transplantation.
- Patients with severe comorbidity affecting survival.
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 |
|---|---|---|
| Remote respiratory physiotherapyRemote respiratory physiotherapy protocol supervised 3 times a week via digital video conferencing, based on Chilean national guidelines for cystic fibrosis. Each 1-hour session (3×/week for 6 months) includes: Evaluation: respiratory assessment, teaching and reinforcement of airway clearance techniques, inhaled medication use, physical activity, and adherence to non-physiotherapy care. Six checklists are used to guide and monitor weekly patient activities. Respiratory physiotherapy: conducted on-screen by the patient or caregiver, guided remotely. Includes: short-acting bronchodilator (if indicated), 7% hypertonic saline nebulization (10 min), 5-min Flutter/Acapella, ELTGOL or ELPr (2×5 min), and assisted coughing. Re-evaluation: reassessment with the initial checklist, Q\&A, and scheduling the next session. Participants continue their usual hospital-based care and receive baseline and post-intervention measurements. | Other | Remote physiotherapy group |
Primary outcome
Exacerbations frequency
Time frame: Frequency of respiratory exacerbations will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.
Frequency of respiratory exacerbations over six months expressed as proportion of subjects with <1 exacerbation, 1-2 exacerbations, or >2 exacerbations), using the medical record.
9 secondary outcomes
Health-related quality of life
Time frame: Health-related quality of life will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.
FEV1
Time frame: FEV1 will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.
Days of hospitalization
Time frame: Days of hospitalization will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.
Days on intravenous/oral antibiotic treatment for respiratory causes
Time frame: Days on intravenous/oral antibiotic treatment will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.
Exercise capacity
Time frame: Exercise capacity will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.
Treatment adherence
Time frame: Treatment adherence will be assessed at the end of the study, i.e. six months after the beginning of the intervention.
Adverse events
Time frame: The occurrence of adverse events will be assessed from the beginning of the intervention up to six months after the beginning of the intervention.
FVC
Time frame: FVC will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.
FEV1/FVC
Time frame: FEV1/FVC will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.
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 28 Jul 2025.
- Background: PubMed 22129901Lavie M, Vilozni D, Sokol G, Somech R, Szeinberg A, Efrati O. Hospital versus home treatment of respiratory exacerbations in cystic fibrosis. Med Sci Monit. 2011 Dec;17(12):CR698-703. doi: 10.12659/msm.882129.
- Background: PubMed 25927329Goodfellow NA, Hawwa AF, Reid AJ, Horne R, Shields MD, McElnay JC. Adherence to treatment in children and adolescents with cystic fibrosis: a cross-sectional, multi-method study investigating the influence of beliefs about treatment and parental depressive symptoms. BMC Pulm Med. 2015 Apr 26;15:43. doi: 10.1186/s12890-015-0038-7.
- Background: PubMed 14985563Thornton J, Elliott R, Tully MP, Dodd M, Webb AK. Long term clinical outcome of home and hospital intravenous antibiotic treatment in adults with cystic fibrosis. Thorax. 2004 Mar;59(3):242-6. doi: 10.1136/thx.2003.005876.
- Individual participant dataSharing planned: No. Because it has not been required by other researchers.
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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?
A study testing Remote respiratory physiotherapy in people with Cystic Fibrosis, run by University of Americas - Chili at 1 site in Chile.
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 3 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 28 Jul 2025. 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 Chile. 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?
Exacerbations frequency (time frame: Frequency of respiratory exacerbations will be assessed at the baseline, 2 weeks maximum before the beginning of the intervention, and at the end of the study, i.e. six months after the beginning of the intervention.). 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 NCT07088614, which also lists 3 linked publications.
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 Jul 2025.