AsthmaDAPF-CSLNCT05439915
Asthma Diagnosis Through Peak Flows
An observational study of Asthma, run by Consorci Sanitari de Terrassa.
Trial summary
The guidelines indicate the possibility of diagnosing asthma through peak flow. This recommendation being the result of expert consensus, but the evidence is limited and contradictory. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Asthma
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Jul 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients visiting in an urban health centre with clinical suspition of asthma, not yet confirmed.
Who may be able to join
- Suspition of asthma, not yet confirmed.
Who cannot join
- No acceptance.
About this study
Official title: Pilot Study of Asthma Diagnosis Through Peak Flows
The guidelines indicate the possibility of diagnosing asthma through peak flow. This recommendation being the result of expert consensus, but the evidence is limited and contradictory. The aim of the present study is to assess whether the diagnosis of asthma through peak flow is not inferior to that of spirometry with bronchodilator test, which is the gold standard test. This is a pilot study to validate a diagnostic test. Its location is an urban health centre (CAP Sant Llàtzer of the Consorci Sanitari de Terrassa). Participation will be offered to all adult patients (18 years of age or older) who are suspected of having an asthma diagnosis. On the one hand, the reversibility will be determined by performing the peak flow test in the center with the administration of 4 puffs of salbutamol. On the other hand, PBD spirometry will be performed to complete the study and diagnosis of the patient. Peak flow is faster, cheaper, simpler, more accessible and safer for professionals in the context of an airbone pandemic.
Read the detailed description
The pandemic has had a strong impact on healthcare quality standards in Catalonia. Prioritization at the primary level of immediate care over scheduled care has led to a decrease in continuity in patient care.
Asthma is a common treatable disease and exacerbations are preventable with proper staging and treatment if necessary. During the present pandemic, the ability to diagnose it through the test of choice (spirometry with bronchodilator test) has been compromised, taking into account the risks arising for health personnel to perform. This fact has conditioned that in the pandemic context it is recommended to limit its use as much as possible.
These reasons led to the suspension of spirometry at the beginning of the pandemic and later, although they have been restarted with the indicated filters to improve safety for patients and professionals, it has not been possible to restore normally for issues arising from the care pressure associated with the pandemic.
When the investigators reviewed the clinical guidelines, they specify that the diagnosis of asthma can also be made by measuring the maximum expiratory flow (PEF) with the peak flow. The measurement of PEF is simple, objective, non-invasive, and adds value to daily clinical practice, helping to define severity and contributing to patient self-management of the disease. The guidelines recommend that the diagnosis through peak flow is a degree of evidence C as the studies are very small samples and therefore the recommendation is based more on the consensus of experts than on the studies available.
However, these guidelines propose two alternative techniques: variability and reversibility.
The first is to measure with the peak flow of the daily variability of the maximum expiratory flow (PEF) in 2 weeks that would allow to diagnose asthma. But there is a difference in criteria in the variability of PEF per se between the two most frequently used guides in our environment.
On the one hand, according to the criteria in the Spanish Guide to Asthma Management (GEMA) the variability required for diagnosis must be greater than or equal to 20% in more than three days in a week for a two-week record. On the other hand, in the Global Initiative for Asthma (GINA) the diagnosis would be with a minimum variability of 10% in a single week, also monitored for a period of two weeks.
Both documents also explain the second technique: the possibility of using the reversibility of pre- and post-bronchodilation PEF with 4 Salbutamol poufs as a diagnostic tool. In this case, both guidelines agree that a reversibility greater than 20% would be a value to be taken into account in the diagnosis of asthma.
According to the available literature, the daily variability of PEF correlates better with bronchial hyperreactivity than with symptoms and airway obstruction, when used for monitoring asthmatic patients already known to have clinical stability. This variability provides information on the risk of exacerbations, and has long been recognized as a possible diagnostic tool (8).
Monitoring of PEF variability in children is insufficient to recommend this technique (9,10), although we must keep in mind that the diagnosis and monitoring of asthma in children is more difficult than in adults.
Other disadvantages of PEF should also be borne in mind: low reproducibility, lack of precise reference values in population groups and may underestimate airway obstruction. Some studies suggest that the usefulness of PEF for the diagnosis of asthma should be reconsidered despite what the guidelines recommend, while others recommend its use.
It is because of this need and the contradictions in the method and in the available evidence that the investigators propose to review patients who have pending spirometry with a suspected diagnosis of asthma and who have also not been able to perform them due to problems related to pandemic.
People with suspected asthma criteria will have a PEF test with a peak flow at the pre- and post-administration center of salbutamol to check the diagnosis for reversibility. In the pilot study, we do not plan to carry out peak flow controls at home for 14 days to assess variability in an attempt to keep it simpler, but we do consider a larger study with more centers depending on funding possibilities. The investigators will review these data if they can be correlated with the results of the same patients in a spirometry with bronchodilator test as this technique becomes available and it is possible to perform it safely for health personnel.
- Conditions
- Asthma
- Keywords
- asthma - diagnosis, maximal expiratory flow rate
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis of asthma
Diagnosis of asthma through reversivility in peak flow compared to spirometry with bronchodilator test.
Measured: 2 months
Secondary outcomes (5)
Acceptation
Degree of acceptance of the patients with respect to the technique of the reversibility of the peak flows.
Measured: 2 months
Ratios
To calculate the ratio of positive and negative likelihood for the reversibility of the peak flow
Measured: 2 months
Sensitivity and specifity
To calculate the sensitivity and specificity for the reversibility of the peak flow with respect to spirometry with bronchodilator test.
Measured: 2 months
Preference
To know the patients 'preference between spirometry with bronchodilator test and the reversibility of the peak flow.
Measured: 2 months
Predisposition
To know the predisposition of patients to perform a study of variability with peak flows for 14 days.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study startJul 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Torras Borrell, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439915
- Sponsor's protocol ID
- 02-22-161-062
- Acronym
- DAPF-CSL
- Status last verified
- Jul 2022
- First submitted
- 27 Jun 2022
- Last updated
- 8 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coma E, Mora N, Mendez L, Benitez M, Hermosilla E, Fabregas M, Fina F, Mercade A, Flayeh S, Guiriguet C, Ballo E, Martinez Leon N, Mas A, Cordomi S, Lejardi Y, Medina M. Primary care in the time of COVID-19: monitoring the effect of the pandemic and the lockdown measures on 34 quality of care indicators calculated for 288 primary care practices covering about 6 million people in Catalonia. BMC Fam Pract. 2020 Oct 10;21(1):208. doi: 10.1186/s12875-020-01278-8.
PubMed 33038926Coma E, Mora N, Peremiquel-Trillas P, Benitez M, Mendez L, Mercade A, Fina F, Fabregas M, Medina M. Influence of organization and demographic characteristics of primary care practices on continuity of care: analysis of a retrospective cohort from 287 primary care practices covering about 6 million people in Catalonia. BMC Fam Pract. 2021 Mar 25;22(1):56. doi: 10.1186/s12875-021-01414-y.
PubMed 33761874Crimi C, Impellizzeri P, Campisi R, Nolasco S, Spanevello A, Crimi N. Practical considerations for spirometry during the COVID-19 outbreak: Literature review and insights. Pulmonology. 2021 Sep-Oct;27(5):438-447. doi: 10.1016/j.pulmoe.2020.07.011. Epub 2020 Aug 5.
PubMed 32800783Reddel HK, Salome CM, Peat JK, Woolcock AJ. Which index of peak expiratory flow is most useful in the management of stable asthma? Am J Respir Crit Care Med. 1995 May;151(5):1320-5. doi: 10.1164/ajrccm.151.5.7735580.
PubMed 7735580Reddel HK, Taylor DR, Bateman ED, Boulet LP, Boushey HA, Busse WW, Casale TB, Chanez P, Enright PL, Gibson PG, de Jongste JC, Kerstjens HA, Lazarus SC, Levy ML, O'Byrne PM, Partridge MR, Pavord ID, Sears MR, Sterk PJ, Stoloff SW, Sullivan SD, Szefler SJ, Thomas MD, Wenzel SE; American Thoracic Society/European Respiratory Society Task Force on Asthma Control and Exacerbations. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009 Jul 1;180(1):59-99. doi: 10.1164/rccm.200801-060ST.
PubMed 19535666Hetzel MR, Clark TJ. Comparison of normal and asthmatic circadian rhythms in peak expiratory flow rate. Thorax. 1980 Oct;35(10):732-8. doi: 10.1136/thx.35.10.732.
PubMed 7466721Brouwer AF, Brand PL. Asthma education and monitoring: what has been shown to work. Paediatr Respir Rev. 2008 Sep;9(3):193-9; quiz 199-200. doi: 10.1016/j.prrv.2008.03.001. Epub 2008 Jul 30.
PubMed 18694711Sly PD, Landau LI, Weymouth R. Home recording of peak expiratory flow rates and perception of asthma. Am J Dis Child. 1985 May;139(5):479-82. doi: 10.1001/archpedi.1985.02140070053032.
PubMed 3984972Vaughan TR, Weber RW, Tipton WR, Nelson HS. Comparison of PEFR and FEV1 in patients with varying degrees of airway obstruction. Effect of modest altitude. Chest. 1989 Mar;95(3):558-62. doi: 10.1378/chest.95.3.558.
PubMed 2920583Goldstein MF, Veza BA, Dunsky EH, Dvorin DJ, Belecanech GA, Haralabatos IC. Comparisons of peak diurnal expiratory flow variation, postbronchodilator FEV(1) responses, and methacholine inhalation challenges in the evaluation of suspected asthma. Chest. 2001 Apr;119(4):1001-10. doi: 10.1378/chest.119.4.1001.
PubMed 11296161Jamison JP, McKinley RK. Validity of peak expiratory flow rate variability for the diagnosis of asthma. Clin Sci (Lond). 1993 Sep;85(3):367-71. doi: 10.1042/cs0850367.
PubMed 8403810Pignataro FS, Bonini M, Forgione A, Melandri S, Usmani OS. Asthma and gender: The female lung. Pharmacol Res. 2017 May;119:384-390. doi: 10.1016/j.phrs.2017.02.017. Epub 2017 Feb 24.
PubMed 28238829
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Asthma Diagnosis Through Peak Flows
- ClinicalTrials.gov ID
- NCT05439915
- Acronym / sponsor ID
- DAPF-CSL / 02-22-161-062
- Conditions
- Asthma
- Keywords
- asthma - diagnosis, maximal expiratory flow rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 30 Jun 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.
The guidelines indicate the possibility of diagnosing asthma through peak flow. This recommendation being the result of expert consensus, but the evidence is limited and contradictory. The aim of the present study is to assess whether the diagnosis of asthma through peak flow is not inferior to that of spirometry with bronchodilator test, which is the gold standard test. This is a pilot study to validate a diagnostic test. Its location is an urban health centre (CAP Sant Llàtzer of the Consorci Sanitari de Terrassa). Participation will be offered to all adult patients (18 years of age or older) who are suspected of having an asthma diagnosis. On the one hand, the reversibility will be determined by performing the peak flow test in the center with the administration of 4 puffs of salbutamol. On the other hand, PBD spirometry will be performed to complete the study and diagnosis of the patient. Peak flow is faster, cheaper, simpler, more accessible and safer for professionals in the context of an airbone pandemic.
Detailed description
The pandemic has had a strong impact on healthcare quality standards in Catalonia. Prioritization at the primary level of immediate care over scheduled care has led to a decrease in continuity in patient care.
Asthma is a common treatable disease and exacerbations are preventable with proper staging and treatment if necessary. During the present pandemic, the ability to diagnose it through the test of choice (spirometry with bronchodilator test) has been compromised, taking into account the risks arising for health personnel to perform. This fact has conditioned that in the pandemic context it is recommended to limit its use as much as possible.
These reasons led to the suspension of spirometry at the beginning of the pandemic and later, although they have been restarted with the indicated filters to improve safety for patients and professionals, it has not been possible to restore normally for issues arising from the care pressure associated with the pandemic.
When the investigators reviewed the clinical guidelines, they specify that the diagnosis of asthma can also be made by measuring the maximum expiratory flow (PEF) with the peak flow. The measurement of PEF is simple, objective, non-invasive, and adds value to daily clinical practice, helping to define severity and contributing to patient self-management of the disease. The guidelines recommend that the diagnosis through peak flow is a degree of evidence C as the studies are very small samples and therefore the recommendation is based more on the consensus of experts than on the studies available.
However, these guidelines propose two alternative techniques: variability and reversibility.
The first is to measure with the peak flow of the daily variability of the maximum expiratory flow (PEF) in 2 weeks that would allow to diagnose asthma. But there is a difference in criteria in the variability of PEF per se between the two most frequently used guides in our environment.
On the one hand, according to the criteria in the Spanish Guide to Asthma Management (GEMA) the variability required for diagnosis must be greater than or equal to 20% in more than three days in a week for a two-week record. On the other hand, in the Global Initiative for Asthma (GINA) the diagnosis would be with a minimum variability of 10% in a single week, also monitored for a period of two weeks.
Both documents also explain the second technique: the possibility of using the reversibility of pre- and post-bronchodilation PEF with 4 Salbutamol poufs as a diagnostic tool. In this case, both guidelines agree that a reversibility greater than 20% would be a value to be taken into account in the diagnosis of asthma.
According to the available literature, the daily variability of PEF correlates better with bronchial hyperreactivity than with symptoms and airway obstruction, when used for monitoring asthmatic patients already known to have clinical stability. This variability provides information on the risk of exacerbations, and has long been recognized as a possible diagnostic tool (8).
Monitoring of PEF variability in children is insufficient to recommend this technique (9,10), although we must keep in mind that the diagnosis and monitoring of asthma in children is more difficult than in adults.
Other disadvantages of PEF should also be borne in mind: low reproducibility, lack of precise reference values in population groups and may underestimate airway obstruction. Some studies suggest that the usefulness of PEF for the diagnosis of asthma should be reconsidered despite what the guidelines recommend, while others recommend its use.
It is because of this need and the contradictions in the method and in the available evidence that the investigators propose to review patients who have pending spirometry with a suspected diagnosis of asthma and who have also not been able to perform them due to problems related to pandemic.
People with suspected asthma criteria will have a PEF test with a peak flow at the pre- and post-administration center of salbutamol to check the diagnosis for reversibility. In the pilot study, we do not plan to carry out peak flow controls at home for 14 days to assess variability in an attempt to keep it simpler, but we do consider a larger study with more centers depending on funding possibilities. The investigators will review these data if they can be correlated with the results of the same patients in a spirometry with bronchodilator test as this technique becomes available and it is possible to perform it safely for health personnel.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients visiting in an urban health centre with clinical suspition of asthma, not yet confirmed.
Key inclusion criteria (1 listed)
- Suspition of asthma, not yet confirmed.
Key exclusion criteria (1 listed)
- No acceptance.
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
Diagnosis of asthma
Time frame: 2 months
Diagnosis of asthma through reversivility in peak flow compared to spirometry with bronchodilator test.
5 secondary outcomes
Acceptation
Time frame: 2 months
Ratios
Time frame: 2 months
Sensitivity and specifity
Time frame: 2 months
Preference
Time frame: 2 months
Predisposition
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2022.
- Background: PubMed 33038926Coma E, Mora N, Mendez L, Benitez M, Hermosilla E, Fabregas M, Fina F, Mercade A, Flayeh S, Guiriguet C, Ballo E, Martinez Leon N, Mas A, Cordomi S, Lejardi Y, Medina M. Primary care in the time of COVID-19: monitoring the effect of the pandemic and the lockdown measures on 34 quality of care indicators calculated for 288 primary care practices covering about 6 million people in Catalonia. BMC Fam Pract. 2020 Oct 10;21(1):208. doi: 10.1186/s12875-020-01278-8.
- Background: PubMed 33761874Coma E, Mora N, Peremiquel-Trillas P, Benitez M, Mendez L, Mercade A, Fina F, Fabregas M, Medina M. Influence of organization and demographic characteristics of primary care practices on continuity of care: analysis of a retrospective cohort from 287 primary care practices covering about 6 million people in Catalonia. BMC Fam Pract. 2021 Mar 25;22(1):56. doi: 10.1186/s12875-021-01414-y.
- Background: PubMed 32800783Crimi C, Impellizzeri P, Campisi R, Nolasco S, Spanevello A, Crimi N. Practical considerations for spirometry during the COVID-19 outbreak: Literature review and insights. Pulmonology. 2021 Sep-Oct;27(5):438-447. doi: 10.1016/j.pulmoe.2020.07.011. Epub 2020 Aug 5.
- Background: PubMed 7735580Reddel HK, Salome CM, Peat JK, Woolcock AJ. Which index of peak expiratory flow is most useful in the management of stable asthma? Am J Respir Crit Care Med. 1995 May;151(5):1320-5. doi: 10.1164/ajrccm.151.5.7735580.
- Background: PubMed 19535666Reddel HK, Taylor DR, Bateman ED, Boulet LP, Boushey HA, Busse WW, Casale TB, Chanez P, Enright PL, Gibson PG, de Jongste JC, Kerstjens HA, Lazarus SC, Levy ML, O'Byrne PM, Partridge MR, Pavord ID, Sears MR, Sterk PJ, Stoloff SW, Sullivan SD, Szefler SJ, Thomas MD, Wenzel SE; American Thoracic Society/European Respiratory Society Task Force on Asthma Control and Exacerbations. An official American Thoracic Society/European Respiratory Society statement: asthma control and exacerbations: standardizing endpoints for clinical asthma trials and clinical practice. Am J Respir Crit Care Med. 2009 Jul 1;180(1):59-99. doi: 10.1164/rccm.200801-060ST.
- Background: PubMed 7466721Hetzel MR, Clark TJ. Comparison of normal and asthmatic circadian rhythms in peak expiratory flow rate. Thorax. 1980 Oct;35(10):732-8. doi: 10.1136/thx.35.10.732.
- Background: PubMed 18694711Brouwer AF, Brand PL. Asthma education and monitoring: what has been shown to work. Paediatr Respir Rev. 2008 Sep;9(3):193-9; quiz 199-200. doi: 10.1016/j.prrv.2008.03.001. Epub 2008 Jul 30.
- Background: PubMed 3984972Sly PD, Landau LI, Weymouth R. Home recording of peak expiratory flow rates and perception of asthma. Am J Dis Child. 1985 May;139(5):479-82. doi: 10.1001/archpedi.1985.02140070053032.
- Background: PubMed 2920583Vaughan TR, Weber RW, Tipton WR, Nelson HS. Comparison of PEFR and FEV1 in patients with varying degrees of airway obstruction. Effect of modest altitude. Chest. 1989 Mar;95(3):558-62. doi: 10.1378/chest.95.3.558.
- Background: PubMed 11296161Goldstein MF, Veza BA, Dunsky EH, Dvorin DJ, Belecanech GA, Haralabatos IC. Comparisons of peak diurnal expiratory flow variation, postbronchodilator FEV(1) responses, and methacholine inhalation challenges in the evaluation of suspected asthma. Chest. 2001 Apr;119(4):1001-10. doi: 10.1378/chest.119.4.1001.
- Background: PubMed 8403810Jamison JP, McKinley RK. Validity of peak expiratory flow rate variability for the diagnosis of asthma. Clin Sci (Lond). 1993 Sep;85(3):367-71. doi: 10.1042/cs0850367.
- Background: PubMed 28238829Pignataro FS, Bonini M, Forgione A, Melandri S, Usmani OS. Asthma and gender: The female lung. Pharmacol Res. 2017 May;119:384-390. doi: 10.1016/j.phrs.2017.02.017. Epub 2017 Feb 24.
- GEMA 5.0. Guía española para el manejo del asma. Sociedad Española de Neumología y Cirugía Torácica, 2020. ISBN: 978-84-17372-97-2.Link provided by the sponsor.
- Global initiative for Asthma. Global Strategy for Asthma Management and Prevention, 2021.Link provided by the sponsor.
- Instituto Nacional de estadística.Link provided by the sponsor.
- CIBERES: Centro de investigación biomédica en red de enfermedades respiratorias.Link provided by the sponsor.
- Miquel-Gomara Perelló J, Román Rodríguez M. Medidor de Peak-flow: técnica de manejo y utilidad en Atención Primaria. MEDIFAM, 2002; 3: 206-213.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Asthma
Recruiting
Characterization of Natural Killer Cells in Severe Asthma Patients in Comparison With Control Subjects
Asthma Acute
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Consorci Sanitari de Terrassa.
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 1 inclusion and 1 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 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Diagnosis of asthma (time frame: 2 months). 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 NCT05439915, which also lists 12 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 8 Jul 2022; AzTrials last refreshed its copy on 30 Oct 2026.