Air PollutionGEOHealth-IINCT05570552
1/2- Bangladesh Center for Global Environmental and Occupational Health- Bangladesh
A study testing mHealth based behavioral change communication intervention in people with Air Pollution and mHealth Intervention, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
Almost 3 billion people worldwide, including 89% people in Bangladesh, are exposed to harmful household air pollutants (HAP) emitted from combustion of biomass (wood, agricultural residue, cow dung, etc.) fuel use for cooking. Read more about this study
- Who is it for?
- Ages 25 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Air Pollution, mHealth Intervention, Cardiopulmonary Function
- What is being tested?
- mHealth based behavioral change communication intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteBangladesh
- Study dates
- 20 Jun 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 25 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants in the previous GEOHEALTH round-I study
- Aged between 25 and 70 years
- Live in biomass-using home with traditional stoves
- Non-smoker and live with non-smokers
- Exposed to <10 µg/L of water arsenic
Who cannot join
- Known to have immune related illness or taking any prescription medication (particularly those that suppress or enhance immune function)
- Known to have any clinical events of CVD or lung disease, including stroke or coronary heart disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
International Centre for Diarrhoeal Diseases Research, Bangladesh
Dhaka, 1212
Rubhana Raqib, PhD, +8802222277001-10 ext. 2404, rubhana@icddrb.org
Rubhana Raqib, PhD
About this study
Official title: Long Term Effects of Household Air Pollution (HAP) Reduction on Cardio-pulmonary and Immune Function Outcomes - a Household Level Randomized mHealth Intervention Trial
Almost 3 billion people worldwide, including 89% people in Bangladesh, are exposed to harmful household air pollutants (HAP) emitted from combustion of biomass (wood, agricultural residue, cow dung, etc.) fuel use for cooking. While health risks associated with air-pollution have been reasonably well-studied in developed countries, there is little evidence on health benefits achievable by HAP reduction through clean fuel use, especially in low- and middle-income countries (LMICs). Earlier the investigators showed that Liquid Petroleum Gas (LPG) for 24 months, reduced personal PM2.5 exposure by 58.17 percent which induced novel changes in immune and inflammatory responses in the participants; however cardiopulmonary markers remained relatively stable in post-intervention assessment.
In this study, the investigators aim to evaluate the effects of mobile phone based (mHealth) Behavioural Change Communication (BCC) intervention on adoption and exclusive use of LPG. The investigators also aimed to observe whether long-term effects of HAP reduction can impact the subclinical measures of cardio-vascular and pulmonary dysfunction and regulate innate and inflammatory immune function among women and children in semi-rural settings in Bangladesh. The investigators will also investigate the influence of exposure to HAP on antibody response to vaccines (adaptive immunity). The BCC intervention will be provided by conducting a large household level randomized controlled trial by educational intervention using mHealth based technology. In addition, the investigators will continue following the cohort and will conduct rigorous and repeated personalized (24 hours) and area (over 5 days) assessments of PM2.5 and black carbon (BC) exposure to examine the long-term effects of HAP reduction on subclinical measures of cardio-pulmonary and immune dysfunction including effect of HAP exposure on antibody response to vaccine.
Read the detailed description
Background:
Almost 3 billion people worldwide, including 89% people in Bangladesh, are exposed to harmful household air pollutants (HAP) emitted from combustion of biomass fuel (wood, agricultural residue, cow dung, etc.) used for cooking. While health risks associated with air-pollution have been reasonably well-studied in developed countries, there is little evidence on health benefits achievable by HAP reduction through clean fuel use such as Liquid Petroleum Gas, especially in low- and middle-income countries (LMICs).
Rationale: In the earlier GEOHealth (Round-I) study, the investigators have shown that LPG for 24 months, reduced personal PM2.5 exposure by 58.2 percent which induced novel changes in innate immune and inflammatory responses in women but the changes in chronic cardio-pulmonary markers were not prominent, most likely due to short duration of follow up and probably impact of ambient pollution. Moreover, sustained use of LPG could be challenging as earlier GEOHealth (Round-I) study provided the cook stove and supply of LPG free of cost. A post-completion screening showed >70% households continued using LPG albeit not exclusively. It is plausible that an intervention using mobile phone-based application can improve the exclusive use of LPG in the communities.
Hypothesis:
- The mobile phone based (mHealth) Behavioural Change Communication (BCC) intervention can be easily incorporated in Government policy that can promote adoption, and increase exclusive use of LPG in the communities. The long-term effect of HAP reduction can be associated with-
- subclinical measures of cardio-vascular and pulmonary dysfunction.
- balanced changes in innate/ inflammatory and adaptive immune function (vaccine response).
Objectives: To evaluate
- The effects of a scalable educational intervention (using mHealth application) on adoption and exclusive use of LPG.
- The long-term effects of HAP reduction on subclinical measures of cardio-vascular and pulmonary dysfunction.
- The long-term effects of HAP reduction on innate/ inflammatory immune function among women and children and to investigate the influence of HAP exposure on antibody response to vaccines (adaptive immunity).
Methods: The investigators will conduct a large household level randomized controlled trial by educational intervention using mobile phone (mHealth) based technology. In addition, the investigators will continue following the cohort and will conduct rigorous and repeated personalized (24 hours) and area-wise (over 5 days) assessments of PM2.5 and black carbon (BC) exposure to examine the long-term effects of HAP reduction on subclinical measures of cardio-pulmonary and immune dysfunction including effect of HAP exposure on antibody response to vaccine.
Outcome measures/variables: Personal and surrounding area PM2.5 and BC level will be measured at pre- and post-intervention. Lung function and lung pathology will be assessed through spirometry, Chest X-ray, and High-resolution Computed tomography of the chest (HRCT). Preclinical makers of cardiovascular diseases (CVD) will include blood pressure and EKG. Markers of metabolic dysfunction will be assesses by measuring HbA1c and fasting lipid profile. Immune function will be assessed by phenotyping of Immune cells, functional cytotoxic killer cells, oxidative stress of lymphocytes.
- Being tested
- mHealth based behavioral change communication intervention
- Keywords
- Mobile based Behavioral Change Communication intervention, Household air pollution reduction, Cardiopulmonary function, Immune function, Clean fuel LPG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth based behavioral change communication interventionBehavioural
Also called value sensitive design (VSD), Fogg Behavior Model (FBM), System Usability Scale (SUS)
We will implement a mHealth based communication system. The number of text messages and push notifications that a participant receives, will be variable and will occur at least weekly (based upon their responses) or the participant opts out of receiving messages. Participant change of behavior and use of improved stoves will be monitored by tracking clicks/views of educational materials and video vignettes.
| Study group | Role | What they receive |
|---|---|---|
| mHealth arm | Experimental | mHealth arm will receive mobile phone based behavior change communication intervention to exclusively use clean fuel LPG for domestic cooking. Receives: Behavioral: mHealth based behavioral change communication intervention |
| Control arm | No intervention | Control arm will receive no mHealth based intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal air pollution
Measurement of personal air pollution (PM2.5 and BC level) by personal air pollution monitoring device
Measured: Pre-intervention
Personal air pollution
Measurement of personal air pollution (PM2.5 and BC level) by personal air pollution monitoring device
Measured: Two-year post intervention
Ambient air pollution
Measurement of ambient air pollution (PM2.5) by ambient air monitoring device
Measured: Pre-intervention
Ambient air pollution
Measurement of ambient air pollution (PM2.5) by ambient air monitoring device
Measured: Two-year post intervention
Lung function assessment by spirometry
Lung function assessment by spirometry
Measured: Pre-intervention
Lung function assessment by spirometry
Lung function assessment by spirometry
Measured: Two-year post intervention
Assessment lung pathology by chest X-ray and High-resolution Computed tomography
Lung pathology will be assessed by chest X-ray for all participants and high-resolution Computed tomography of the chest (HRCT) will be performed in selected participants.
Measured: Pre-intervention
Assessment lung pathology by chest X-ray and High-resolution Computed tomography
Lung pathology will be assessed by chest X-ray for all participants and high-resolution Computed tomography of the chest (HRCT) will be performed in selected participants.
Measured: Two-year post intervention
Measurement of cardiovascular disease (CVD) markers by measuring blood pressure
Preclinical markers of CVD assessment by blood pressure
Measured: Pre-intervention
Measurement of cardiovascular disease (CVD) markers by measuring blood pressure
Preclinical markers of CVD assessment by blood pressure
Measured: Two-year post intervention
Measurement of cardiovascular disease (CVD) markers by performing EKG
Preclinical markers of CVD assessment by EKG
Measured: Pre-intervention
Measurement of cardiovascular disease (CVD) markers by performing EKG
Preclinical markers of CVD assessment by EKG
Measured: Two-year post intervention
Evaluation of metabolic markers (diabetes) in blood at baseline.
Assessment of metabolic dysfunction by measuring HbA1c
Measured: Pre-intervention
Evaluation of metabolic markers (diabetes) in blood after intervention.
Assessment of metabolic dysfunction by measuring HbA1c
Measured: Two-year post intervention
Evaluation of metabolic markers (CVD) in blood.
Assessment of metabolic dysfunction by measuring fasting lipid profile.
Measured: Pre-intervention
Evaluation of metabolic markers (CVD) in blood.
Assessment of metabolic dysfunction by measuring fasting lipid profile.
Measured: Two-year post intervention
Assessment of immune function in blood cells
Immune function will be assessed by phenotyping using flowcytometry
Measured: Pre-intervention
Assessment of immune function in blood cells
Immune function will be assessed by phenotyping using flowcytometry
Measured: Two-year post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start20 Jun 2023
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Air PollutionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago, Mailman School of Public Health, Marquette University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570552
- Sponsor's protocol ID
- PR-22057 (2U01TW010120-06)
- Acronym
- GEOHealth-II
- Status last verified
- Mar 2024
- First submitted
- 29 Aug 2022
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data collected of the proposed study will be made fully available to any bonafide researcher. In general, the investigators will follow the data sharing plan developed and practiced by the NIH-funded grantees. Any data request by external researchers will be reviewed by the PIs and the AOC and the requested specific data will be made available to the through a secured web-based interface developed specifically for this project. In general, data will be made available six months after the manuscript reporting results from those specific sets of data are accepted for publication and all data requests will be processed within six months from the receipt of the request in writing. Any data requests with potential conflicts will be reviewed and decided by the AOC.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Effects of Household Air Pollution (HAP) Reduction on Cardio-pulmonary and Immune Function Outcomes - a Household Level Randomized mHealth Intervention Trial
- ClinicalTrials.gov ID
- NCT05570552
- Acronym / sponsor ID
- GEOHealth-II / PR-22057 (2U01TW010120-06)
- Keywords
- Mobile based Behavioral Change Communication intervention, Household air pollution reduction, Cardiopulmonary function, Immune function, Clean fuel LPG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- University of Chicago, Mailman School of Public Health, Marquette University
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 6 Oct 2022 (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.
Almost 3 billion people worldwide, including 89% people in Bangladesh, are exposed to harmful household air pollutants (HAP) emitted from combustion of biomass (wood, agricultural residue, cow dung, etc.) fuel use for cooking. While health risks associated with air-pollution have been reasonably well-studied in developed countries, there is little evidence on health benefits achievable by HAP reduction through clean fuel use, especially in low- and middle-income countries (LMICs). Earlier the investigators showed that Liquid Petroleum Gas (LPG) for 24 months, reduced personal PM2.5 exposure by 58.17 percent which induced novel changes in immune and inflammatory responses in the participants; however cardiopulmonary markers remained relatively stable in post-intervention assessment.
In this study, the investigators aim to evaluate the effects of mobile phone based (mHealth) Behavioural Change Communication (BCC) intervention on adoption and exclusive use of LPG. The investigators also aimed to observe whether long-term effects of HAP reduction can impact the subclinical measures of cardio-vascular and pulmonary dysfunction and regulate innate and inflammatory immune function among women and children in semi-rural settings in Bangladesh. The investigators will also investigate the influence of exposure to HAP on antibody response to vaccines (adaptive immunity). The BCC intervention will be provided by conducting a large household level randomized controlled trial by educational intervention using mHealth based technology. In addition, the investigators will continue following the cohort and will conduct rigorous and repeated personalized (24 hours) and area (over 5 days) assessments of PM2.5 and black carbon (BC) exposure to examine the long-term effects of HAP reduction on subclinical measures of cardio-pulmonary and immune dysfunction including effect of HAP exposure on antibody response to vaccine.
Detailed description
Background:
Almost 3 billion people worldwide, including 89% people in Bangladesh, are exposed to harmful household air pollutants (HAP) emitted from combustion of biomass fuel (wood, agricultural residue, cow dung, etc.) used for cooking. While health risks associated with air-pollution have been reasonably well-studied in developed countries, there is little evidence on health benefits achievable by HAP reduction through clean fuel use such as Liquid Petroleum Gas, especially in low- and middle-income countries (LMICs).
Rationale: In the earlier GEOHealth (Round-I) study, the investigators have shown that LPG for 24 months, reduced personal PM2.5 exposure by 58.2 percent which induced novel changes in innate immune and inflammatory responses in women but the changes in chronic cardio-pulmonary markers were not prominent, most likely due to short duration of follow up and probably impact of ambient pollution. Moreover, sustained use of LPG could be challenging as earlier GEOHealth (Round-I) study provided the cook stove and supply of LPG free of cost. A post-completion screening showed >70% households continued using LPG albeit not exclusively. It is plausible that an intervention using mobile phone-based application can improve the exclusive use of LPG in the communities.
Hypothesis:
- The mobile phone based (mHealth) Behavioural Change Communication (BCC) intervention can be easily incorporated in Government policy that can promote adoption, and increase exclusive use of LPG in the communities. The long-term effect of HAP reduction can be associated with-
- subclinical measures of cardio-vascular and pulmonary dysfunction.
- balanced changes in innate/ inflammatory and adaptive immune function (vaccine response).
Objectives: To evaluate
- The effects of a scalable educational intervention (using mHealth application) on adoption and exclusive use of LPG.
- The long-term effects of HAP reduction on subclinical measures of cardio-vascular and pulmonary dysfunction.
- The long-term effects of HAP reduction on innate/ inflammatory immune function among women and children and to investigate the influence of HAP exposure on antibody response to vaccines (adaptive immunity).
Methods: The investigators will conduct a large household level randomized controlled trial by educational intervention using mobile phone (mHealth) based technology. In addition, the investigators will continue following the cohort and will conduct rigorous and repeated personalized (24 hours) and area-wise (over 5 days) assessments of PM2.5 and black carbon (BC) exposure to examine the long-term effects of HAP reduction on subclinical measures of cardio-pulmonary and immune dysfunction including effect of HAP exposure on antibody response to vaccine.
Outcome measures/variables: Personal and surrounding area PM2.5 and BC level will be measured at pre- and post-intervention. Lung function and lung pathology will be assessed through spirometry, Chest X-ray, and High-resolution Computed tomography of the chest (HRCT). Preclinical makers of cardiovascular diseases (CVD) will include blood pressure and EKG. Markers of metabolic dysfunction will be assesses by measuring HbA1c and fasting lipid profile. Immune function will be assessed by phenotyping of Immune cells, functional cytotoxic killer cells, oxidative stress of lymphocytes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth arm | Experimental | Behavioral: mHealth based behavioral change communication interventionmHealth arm will receive mobile phone based behavior change communication intervention to exclusively use clean fuel LPG for domestic cooking. |
| Control arm | No intervention | –Control arm will receive no mHealth based intervention. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants in the previous GEOHEALTH round-I study
- Aged between 25 and 70 years
- Live in biomass-using home with traditional stoves
- Non-smoker and live with non-smokers
- Exposed to <10 µg/L of water arsenic
Key exclusion criteria (2 listed)
- Known to have immune related illness or taking any prescription medication (particularly those that suppress or enhance immune function)
- Known to have any clinical events of CVD or lung disease, including stroke or coronary heart disease.
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 |
|---|---|---|
| mHealth based behavioral change communication interventionAlso: value sensitive design (VSD), Fogg Behavior Model (FBM), System Usability Scale (SUS)We will implement a mHealth based communication system. The number of text messages and push notifications that a participant receives, will be variable and will occur at least weekly (based upon their responses) or the participant opts out of receiving messages. Participant change of behavior and use of improved stoves will be monitored by tracking clicks/views of educational materials and video vignettes. | Behavioural | mHealth arm |
Primary outcome
Personal air pollution
Time frame: Pre-intervention
Measurement of personal air pollution (PM2.5 and BC level) by personal air pollution monitoring device
Personal air pollution
Time frame: Two-year post intervention
Measurement of personal air pollution (PM2.5 and BC level) by personal air pollution monitoring device
Ambient air pollution
Time frame: Pre-intervention
Measurement of ambient air pollution (PM2.5) by ambient air monitoring device
Ambient air pollution
Time frame: Two-year post intervention
Measurement of ambient air pollution (PM2.5) by ambient air monitoring device
Lung function assessment by spirometry
Time frame: Pre-intervention
Lung function assessment by spirometry
Lung function assessment by spirometry
Time frame: Two-year post intervention
Lung function assessment by spirometry
Assessment lung pathology by chest X-ray and High-resolution Computed tomography
Time frame: Pre-intervention
Lung pathology will be assessed by chest X-ray for all participants and high-resolution Computed tomography of the chest (HRCT) will be performed in selected participants.
Assessment lung pathology by chest X-ray and High-resolution Computed tomography
Time frame: Two-year post intervention
Lung pathology will be assessed by chest X-ray for all participants and high-resolution Computed tomography of the chest (HRCT) will be performed in selected participants.
Measurement of cardiovascular disease (CVD) markers by measuring blood pressure
Time frame: Pre-intervention
Preclinical markers of CVD assessment by blood pressure
Measurement of cardiovascular disease (CVD) markers by measuring blood pressure
Time frame: Two-year post intervention
Preclinical markers of CVD assessment by blood pressure
Measurement of cardiovascular disease (CVD) markers by performing EKG
Time frame: Pre-intervention
Preclinical markers of CVD assessment by EKG
Measurement of cardiovascular disease (CVD) markers by performing EKG
Time frame: Two-year post intervention
Preclinical markers of CVD assessment by EKG
Evaluation of metabolic markers (diabetes) in blood at baseline.
Time frame: Pre-intervention
Assessment of metabolic dysfunction by measuring HbA1c
Evaluation of metabolic markers (diabetes) in blood after intervention.
Time frame: Two-year post intervention
Assessment of metabolic dysfunction by measuring HbA1c
Evaluation of metabolic markers (CVD) in blood.
Time frame: Pre-intervention
Assessment of metabolic dysfunction by measuring fasting lipid profile.
Evaluation of metabolic markers (CVD) in blood.
Time frame: Two-year post intervention
Assessment of metabolic dysfunction by measuring fasting lipid profile.
Assessment of immune function in blood cells
Time frame: Pre-intervention
Immune function will be assessed by phenotyping using flowcytometry
Assessment of immune function in blood cells
Time frame: Two-year post intervention
Immune function will be assessed by phenotyping using flowcytometry
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: Yes. All data collected of the proposed study will be made fully available to any bonafide researcher. In general, the investigators will follow the data sharing plan developed and practiced by the NIH-funded grantees. Any data request by external researchers will be reviewed by the PIs and the AOC and the requested specific data will be made available to the through a secured web-based interface developed specifically for this project. In general, data will be made available six months after the manuscript reporting results from those specific sets of data are accepted for publication and all data requests will be processed within six months from the receipt of the request in writing. Any data requests with potential conflicts will be reviewed and decided by the AOC.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth based behavioral change communication intervention in people with Air Pollution and mHealth Intervention, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
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 2 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: looking for participants now, as of the sponsor's last update on 22 Mar 2024. 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 Bangladesh. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rubhana Raqib, PhD (+8802222277001-10 ext. 2404, rubhana@icddrb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal air pollution (time frame: Pre-intervention). The study lists 18 primary outcomes in all. 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 22 Mar 2024.