Respiratory DiseaseNCT04006964
Diagnostic Accuracy Of Forced Oscillation Technique To Detect Lung Function Anomalies
An observational study of Respiratory Disease, run by Restech Srl at 6 sites in 2 countries.
Trial summary
The diagnosis of a lung function anomaly requires the evaluation of pulmonary function by spirometry. However, some patients (e.g. children, elderly, or diseased individuals) may have difficulty performing the related forced maximal respiratory maneuver correctly. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Respiratory Disease
- What is being tested?
- Resmon PRO FULL v2
- Type of treatment
- Medical device
- How many people
- 579 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 18 Oct 2018to 26 Jun 2022
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The following age groups will be considered: * Preschool children (3-5 years old) * School-age children (6-11 years old) * Adolescents (12-17 years old) * Adults (>= 18 years old)
Who may be able to join
- All subjects ≥3 years old attending the pulmonary function laboratory with an order for PFT or
- Subjects ≥3 years old randomly chosen from a database of subjects having respiratory symptoms at the time of inclusion into the database.
Who cannot join
- Subjects unable to provide written Informed Consent (or not provided by the participant's parent/guardian) and Assent Form (where applicable).
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Italy4 sites
ASST Papa Giovanni XXIII
Bergamo, 24127
Azienda Ospedaliero, Universitaria Meyer
Florence, FI, 50139
Istituto di Biomedicina e Immunologia Molecolare "A. Monroy"
Palermo, 90146
Catholic University of the Sacred Heart
Rome, Lazio, 00100
United States2 sites
University of Vermont Medical Center Inc.,
Burlington, Vermont, 05401
Biomedical Research Institute at Harbor- UCLA Medical Center
Los Angeles, California, 90502
About this study
The diagnosis of a lung function anomaly requires the evaluation of pulmonary function by spirometry. However, some patients (e.g. children, elderly, or diseased individuals) may have difficulty performing the related forced maximal respiratory maneuver correctly. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing, requiring minimal patient cooperation. The purpose of this study is to establish the diagnostic accuracy of FOT parameters alone or in combination with lung volumes in detecting lung function anomalies as compared with spirometry and with the diagnosis made by the physician.
Read the detailed description
Purpose and Rationale The diagnosis of a lung function anomaly requires the evaluation of pulmonary function by spirometry. However, some patients (e.g. children, elderly, or diseased individuals) may have difficulty performing the related forced maximal respiratory maneuver correctly. FOT measures lung impedance during tidal breathing, requiring minimal patient cooperation. The within-breath calculation of impedance allows separating the contribution of inspiration and expiration to the measured parameters. The purpose of this study is to establish the diagnostic accuracy of FOT parameters alone or in combination with lung volumes in detecting lung function anomalies as compared with spirometry and with the diagnosis made by the physician.
Objectives Primary: To compare the diagnostic accuracy of FOT with spirometry to detect a lung function anomaly (i.e. an obstructive and/or restrictive respiratory disease).
Secondary: To compare the diagnostic accuracy of FOT with the final diagnosis made by the physician (i.e. the diagnosis based on current guidelines) to detect a lung function anomaly (i.e. an obstructive and/or restrictive respiratory disease).
Study Design This will be a multi-center prospective study of consecutive subjects attending the pulmonary function test laboratory for pulmonary function tests (PFT) or randomly taken from the clinical site's records among those with symptoms with two separate study phases, an Identification Phase and a Validation Phase. Subjects will undergo the same study procedures in both phases. After signing the Informed Consent, a medical history will be obtained, a physical examination performed, and PFT (FOT, spirometry and, if required by the physician to reach a final diagnosis, additional lung function measurements) will be performed.
Identification Phase: Subject data will be used to identify two separate rules based on abnormal lung volumes and impedance (FOT) parameters that will maximize the accuracy in identifying a lung function anomaly. For the primary objective, the reference test for the determination of such lung anomaly will be spirometry. For the secondary objective, the reference test for the determination of the presence of a lung function anomaly will be the final diagnosis made by the physician.
Validation Phase: A separate and independent dataset of subjects will be used to test the accuracy of the rules identified from analysis of the Identification Phase in detecting a lung function anomaly.
Study Duration Subject participation will be completed in 1 day. Study duration is expected to be 7 months
- Conditions
- Respiratory Disease
- Being tested
- Resmon PRO FULL v2
- Medical subject headings
- Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resmon PRO FULL v2Device
Measurement of lung impedance by the Forced Oscillation Technique
| Study group | Role | What they receive |
|---|---|---|
| Identification Group | Subjects >= 3 years old will measure as a minimum FOT and spirometry. Final diagnosis will be made by the physician as per current guidelines. Receives: Device: Resmon PRO FULL v2 | |
| Validation Group | Subjects >= 3 years old will measure as a minimum FOT and spirometry. Final diagnosis will be made by the physician as per current guidelines. Receives: Device: Resmon PRO FULL v2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision rule that maximises sensitivity and specificity as compared with spirometry
This will be a rule to detect lung anomalies as compared with spirometry that will be identified and validated in two separate populations
Measured: 1 day
Secondary outcomes (1)
Decision rule that maximises sensitivity and specificity as compared with physician's diagnosis
This will be a rule to detect lung anomalies as compared with physician's final diagnosis that will be identified and validated in two separate populations
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start18 Oct 2018
- Primary completion26 Jun 2022
- Study completion26 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Respiratory DiseaseStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 579 participants (actual)
Sponsor and investigators
- Lead sponsor
- Restech Srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MGC Diagnostics
- Responsible party
- Sponsor
- Investigators
- Riccardo Inchingolo, MD, Principal investigator, Catholic University of the Sacred HeartStefania La Grutta, MD, Principal investigator, Istituto di Biomedicina e Immunologia Molecolare "A. Monroy"Enrico Lombardi, MD, Principal investigator, Meyer Children's Hospital IRCCSDavid Kaminsky, MD, Principal investigator, University of Vermont Medical Center IncJanos Porszasz, MD, Principal investigator, Biomedical Research Institute at Harbor- UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006964
- Sponsor's protocol ID
- 2/17
- Status last verified
- Nov 2022
- First submitted
- 27 Jun 2019
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Publications
Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, Wanger J. Interpretative strategies for lung function tests. Eur Respir J. 2005 Nov;26(5):948-68. doi: 10.1183/09031936.05.00035205. No abstract available.
PubMed 16264058Miller MR, Crapo R, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. General considerations for lung function testing. Eur Respir J. 2005 Jul;26(1):153-61. doi: 10.1183/09031936.05.00034505. No abstract available.
PubMed 15994402Aurora P, Stocks J, Oliver C, Saunders C, Castle R, Chaziparasidis G, Bush A; London Cystic Fibrosis Collaboration. Quality control for spirometry in preschool children with and without lung disease. Am J Respir Crit Care Med. 2004 May 15;169(10):1152-9. doi: 10.1164/rccm.200310-1453OC. Epub 2004 Mar 17.
PubMed 15028561Woodruff PG, Barr RG, Bleecker E, Christenson SA, Couper D, Curtis JL, Gouskova NA, Hansel NN, Hoffman EA, Kanner RE, Kleerup E, Lazarus SC, Martinez FJ, Paine R 3rd, Rennard S, Tashkin DP, Han MK; SPIROMICS Research Group. Clinical Significance of Symptoms in Smokers with Preserved Pulmonary Function. N Engl J Med. 2016 May 12;374(19):1811-21. doi: 10.1056/NEJMoa1505971.
PubMed 27168432van Noord JA, Wellens W, Clarysse I, Cauberghs M, Van de Woestijne KP, Demedts M. Total respiratory resistance and reactance in patients with upper airway obstruction. Chest. 1987 Sep;92(3):475-80. doi: 10.1378/chest.92.3.475.
PubMed 3622024Zerah F, Lorino AM, Lorino H, Harf A, Macquin-Mavier I. Forced oscillation technique vs spirometry to assess bronchodilatation in patients with asthma and COPD. Chest. 1995 Jul;108(1):41-7. doi: 10.1378/chest.108.1.41.
PubMed 7606989Faria AC, Costa AA, Lopes AJ, Jansen JM, Melo PL. Forced oscillation technique in the detection of smoking-induced respiratory alterations: diagnostic accuracy and comparison with spirometry. Clinics (Sao Paulo). 2010;65(12):1295-304. doi: 10.1590/s1807-59322010001200012.
PubMed 21340218Dellaca RL, Santus P, Aliverti A, Stevenson N, Centanni S, Macklem PT, Pedotti A, Calverley PM. Detection of expiratory flow limitation in COPD using the forced oscillation technique. Eur Respir J. 2004 Feb;23(2):232-40. doi: 10.1183/09031936.04.00046804.
PubMed 14979497Dellaca RL, Aliverti A, Lo Mauro A, Lutchen KR, Pedotti A, Suki B. Correlated variability in the breathing pattern and end-expiratory lung volumes in conscious humans. PLoS One. 2015 Mar 24;10(3):e0116317. doi: 10.1371/journal.pone.0116317. eCollection 2015.
PubMed 25803710Peslin R, Ying Y, Gallina C, Duvivier C. Within-breath variations of forced oscillation resistance in healthy subjects. Eur Respir J. 1992 Jan;5(1):86-92.
PubMed 1577156Dellaca RL, Pompilio PP, Walker PP, Duffy N, Pedotti A, Calverley PM. Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD. Eur Respir J. 2009 Jun;33(6):1329-37. doi: 10.1183/09031936.00139608. Epub 2009 Jan 22.
PubMed 19164347Quanjer PH, Stanojevic S, Cole TJ, Baur X, Hall GL, Culver BH, Enright PL, Hankinson JL, Ip MS, Zheng J, Stocks J; ERS Global Lung Function Initiative. Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global lung function 2012 equations. Eur Respir J. 2012 Dec;40(6):1324-43. doi: 10.1183/09031936.00080312. Epub 2012 Jun 27.
PubMed 22743675Beydon N, Davis SD, Lombardi E, Allen JL, Arets HG, Aurora P, Bisgaard H, Davis GM, Ducharme FM, Eigen H, Gappa M, Gaultier C, Gustafsson PM, Hall GL, Hantos Z, Healy MJ, Jones MH, Klug B, Lodrup Carlsen KC, McKenzie SA, Marchal F, Mayer OH, Merkus PJ, Morris MG, Oostveen E, Pillow JJ, Seddon PC, Silverman M, Sly PD, Stocks J, Tepper RS, Vilozni D, Wilson NM; American Thoracic Society/European Respiratory Society Working Group on Infant and Young Children Pulmonary Function Testing. An official American Thoracic Society/European Respiratory Society statement: pulmonary function testing in preschool children. Am J Respir Crit Care Med. 2007 Jun 15;175(12):1304-45. doi: 10.1164/rccm.200605-642ST. No abstract available.
PubMed 17545458Wanger J, Clausen JL, Coates A, Pedersen OF, Brusasco V, Burgos F, Casaburi R, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson D, Macintyre N, McKay R, Miller MR, Navajas D, Pellegrino R, Viegi G. Standardisation of the measurement of lung volumes. Eur Respir J. 2005 Sep;26(3):511-22. doi: 10.1183/09031936.05.00035005. No abstract available.
PubMed 16135736Brazzale DJ, Hall GL, Pretto JJ. Effects of adopting the new global lung function initiative 2012 reference equations on the interpretation of spirometry. Respiration. 2013;86(3):183-9. doi: 10.1159/000352046. Epub 2013 Aug 14.
PubMed 23949369
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy Of Forced Oscillation Technique To Detect Lung Function Anomalies
- ClinicalTrials.gov ID
- NCT04006964
- Acronym / sponsor ID
- 2/17
- Conditions
- Respiratory Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 579 participants (actual)
- Lead sponsor
- Restech SrlIndustry (pharma, biotech, devices)
- Collaborators
- MGC Diagnostics
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 26 Jun 2022 (actual)
- Study completion
- 26 Jun 2022 (actual)
- First posted
- 5 Jul 2019 (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 diagnosis of a lung function anomaly requires the evaluation of pulmonary function by spirometry. However, some patients (e.g. children, elderly, or diseased individuals) may have difficulty performing the related forced maximal respiratory maneuver correctly. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing, requiring minimal patient cooperation. The purpose of this study is to establish the diagnostic accuracy of FOT parameters alone or in combination with lung volumes in detecting lung function anomalies as compared with spirometry and with the diagnosis made by the physician.
Detailed description
Purpose and Rationale The diagnosis of a lung function anomaly requires the evaluation of pulmonary function by spirometry. However, some patients (e.g. children, elderly, or diseased individuals) may have difficulty performing the related forced maximal respiratory maneuver correctly. FOT measures lung impedance during tidal breathing, requiring minimal patient cooperation. The within-breath calculation of impedance allows separating the contribution of inspiration and expiration to the measured parameters. The purpose of this study is to establish the diagnostic accuracy of FOT parameters alone or in combination with lung volumes in detecting lung function anomalies as compared with spirometry and with the diagnosis made by the physician.
Objectives Primary: To compare the diagnostic accuracy of FOT with spirometry to detect a lung function anomaly (i.e. an obstructive and/or restrictive respiratory disease).
Secondary: To compare the diagnostic accuracy of FOT with the final diagnosis made by the physician (i.e. the diagnosis based on current guidelines) to detect a lung function anomaly (i.e. an obstructive and/or restrictive respiratory disease).
Study Design This will be a multi-center prospective study of consecutive subjects attending the pulmonary function test laboratory for pulmonary function tests (PFT) or randomly taken from the clinical site's records among those with symptoms with two separate study phases, an Identification Phase and a Validation Phase. Subjects will undergo the same study procedures in both phases. After signing the Informed Consent, a medical history will be obtained, a physical examination performed, and PFT (FOT, spirometry and, if required by the physician to reach a final diagnosis, additional lung function measurements) will be performed.
Identification Phase: Subject data will be used to identify two separate rules based on abnormal lung volumes and impedance (FOT) parameters that will maximize the accuracy in identifying a lung function anomaly. For the primary objective, the reference test for the determination of such lung anomaly will be spirometry. For the secondary objective, the reference test for the determination of the presence of a lung function anomaly will be the final diagnosis made by the physician.
Validation Phase: A separate and independent dataset of subjects will be used to test the accuracy of the rules identified from analysis of the Identification Phase in detecting a lung function anomaly.
Study Duration Subject participation will be completed in 1 day. Study duration is expected to be 7 months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Identification Group | – | Device: Resmon PRO FULL v2Subjects >= 3 years old will measure as a minimum FOT and spirometry. Final diagnosis will be made by the physician as per current guidelines. |
| Validation Group | – | Device: Resmon PRO FULL v2Subjects >= 3 years old will measure as a minimum FOT and spirometry. Final diagnosis will be made by the physician as per current guidelines. |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The following age groups will be considered: * Preschool children (3-5 years old) * School-age children (6-11 years old) * Adolescents (12-17 years old) * Adults (>= 18 years old)
Key inclusion criteria (2 listed)
- All subjects ≥3 years old attending the pulmonary function laboratory with an order for PFT or
- Subjects ≥3 years old randomly chosen from a database of subjects having respiratory symptoms at the time of inclusion into the database.
Key exclusion criteria (1 listed)
- Subjects unable to provide written Informed Consent (or not provided by the participant's parent/guardian) and Assent Form (where applicable).
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 |
|---|---|---|
| Resmon PRO FULL v2Measurement of lung impedance by the Forced Oscillation Technique | Device | Identification Group, Validation Group |
Primary outcome
Decision rule that maximises sensitivity and specificity as compared with spirometry
Time frame: 1 day
This will be a rule to detect lung anomalies as compared with spirometry that will be identified and validated in two separate populations
1 secondary outcome
Decision rule that maximises sensitivity and specificity as compared with physician's diagnosis
Time frame: 1 day
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 3 Nov 2022.
- Background: PubMed 16264058Pellegrino R, Viegi G, Brusasco V, Crapo RO, Burgos F, Casaburi R, Coates A, van der Grinten CP, Gustafsson P, Hankinson J, Jensen R, Johnson DC, MacIntyre N, McKay R, Miller MR, Navajas D, Pedersen OF, Wanger J. Interpretative strategies for lung function tests. Eur Respir J. 2005 Nov;26(5):948-68. doi: 10.1183/09031936.05.00035205. No abstract available.
- Background: PubMed 15994402Miller MR, Crapo R, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. General considerations for lung function testing. Eur Respir J. 2005 Jul;26(1):153-61. doi: 10.1183/09031936.05.00034505. No abstract available.
- Background: PubMed 15028561Aurora P, Stocks J, Oliver C, Saunders C, Castle R, Chaziparasidis G, Bush A; London Cystic Fibrosis Collaboration. Quality control for spirometry in preschool children with and without lung disease. Am J Respir Crit Care Med. 2004 May 15;169(10):1152-9. doi: 10.1164/rccm.200310-1453OC. Epub 2004 Mar 17.
- Background: PubMed 27168432Woodruff PG, Barr RG, Bleecker E, Christenson SA, Couper D, Curtis JL, Gouskova NA, Hansel NN, Hoffman EA, Kanner RE, Kleerup E, Lazarus SC, Martinez FJ, Paine R 3rd, Rennard S, Tashkin DP, Han MK; SPIROMICS Research Group. Clinical Significance of Symptoms in Smokers with Preserved Pulmonary Function. N Engl J Med. 2016 May 12;374(19):1811-21. doi: 10.1056/NEJMoa1505971.
- Background: PubMed 3622024van Noord JA, Wellens W, Clarysse I, Cauberghs M, Van de Woestijne KP, Demedts M. Total respiratory resistance and reactance in patients with upper airway obstruction. Chest. 1987 Sep;92(3):475-80. doi: 10.1378/chest.92.3.475.
- Background: PubMed 7606989Zerah F, Lorino AM, Lorino H, Harf A, Macquin-Mavier I. Forced oscillation technique vs spirometry to assess bronchodilatation in patients with asthma and COPD. Chest. 1995 Jul;108(1):41-7. doi: 10.1378/chest.108.1.41.
- Background: PubMed 21340218Faria AC, Costa AA, Lopes AJ, Jansen JM, Melo PL. Forced oscillation technique in the detection of smoking-induced respiratory alterations: diagnostic accuracy and comparison with spirometry. Clinics (Sao Paulo). 2010;65(12):1295-304. doi: 10.1590/s1807-59322010001200012.
- Background: PubMed 14979497Dellaca RL, Santus P, Aliverti A, Stevenson N, Centanni S, Macklem PT, Pedotti A, Calverley PM. Detection of expiratory flow limitation in COPD using the forced oscillation technique. Eur Respir J. 2004 Feb;23(2):232-40. doi: 10.1183/09031936.04.00046804.
- Background: PubMed 25803710Dellaca RL, Aliverti A, Lo Mauro A, Lutchen KR, Pedotti A, Suki B. Correlated variability in the breathing pattern and end-expiratory lung volumes in conscious humans. PLoS One. 2015 Mar 24;10(3):e0116317. doi: 10.1371/journal.pone.0116317. eCollection 2015.
- Background: PubMed 1577156Peslin R, Ying Y, Gallina C, Duvivier C. Within-breath variations of forced oscillation resistance in healthy subjects. Eur Respir J. 1992 Jan;5(1):86-92.
- Background: PubMed 19164347Dellaca RL, Pompilio PP, Walker PP, Duffy N, Pedotti A, Calverley PM. Effect of bronchodilation on expiratory flow limitation and resting lung mechanics in COPD. Eur Respir J. 2009 Jun;33(6):1329-37. doi: 10.1183/09031936.00139608. Epub 2009 Jan 22.
- Background: PubMed 22743675Quanjer PH, Stanojevic S, Cole TJ, Baur X, Hall GL, Culver BH, Enright PL, Hankinson JL, Ip MS, Zheng J, Stocks J; ERS Global Lung Function Initiative. Multi-ethnic reference values for spirometry for the 3-95-yr age range: the global lung function 2012 equations. Eur Respir J. 2012 Dec;40(6):1324-43. doi: 10.1183/09031936.00080312. Epub 2012 Jun 27.
- Global Initiative for Asthma. Global strategy for asthma management and prevention, 2017.Link provided by the sponsor.
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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.
Riccardo Inchingolo, MD principal investigator
Catholic University of the Sacred Heart
Stefania La Grutta, MD principal investigator
Istituto di Biomedicina e Immunologia Molecolare "A. Monroy"
Enrico Lombardi, MD principal investigator
Meyer Children's Hospital IRCCS
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Disease, run by Restech Srl at 6 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 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: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, United States. 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?
Decision rule that maximises sensitivity and specificity as compared with spirometry (time frame: 1 day). 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 NCT04006964, which also lists 17 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 3 Nov 2022.