AsthmaNCT06313372
Interpreting Respiratory Oscillometry in Adult Asthma and COPD: a Delphi Study
An observational study of Asthma and Chronic Obstructive Pulmonary Disease, run by Scius Healthcare Solutions Pty Ltd.
Trial summary
This is an international Delphi study to consolidate expert consensus on the use of respiratory oscillometry in the management of adult patients with asthma or chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Respiratory oscillometry
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Jan 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants in the Delphi study will be respiratory specialists with expertise in the application of respiratory oscillometry in clinical practice and who routinely use respiratory oscillometry in clinical practice. Clinical use is defined as respiratory specialists who order and/or interpret respiratory oscillometry in day-to-day clinical practice.
Who may be able to join
- Respiratory specialist in active clinical practice ≥ 12 months.
- Use respiratory oscillometry ≥ 2 tests per week
Who cannot join
- Only use respiratory oscillometry when participating in clinical trials
- Employee or stockholder of pharmaceutical company
- Employee or stockholder of oscillometry manufacturer
- Employee or stockholder of tobacco/vaping companies.
Trial locations and contacts
No sites are listed yet.
About this study
This is an international Delphi study to consolidate expert consensus on the use of respiratory oscillometry in the management of adult patients with asthma or chronic obstructive pulmonary disease (COPD).
The primary objective of the Delphi study is to aid the interpretation of respiratory oscillometry in clinical practice amongst adult patients with asthma or COPD. This will be achieved by obtaining expert consensus on:
Read more
- Which parameters are used in clinical practice for impulse oscillometry (IOS) and for forced oscillation technique (FOT) devices.
- What cut-offs can be used for each parameter to guide clinical practice in the management of adult patients with asthma and COPD.
This study is based on the Delphi methodology. The Delphi study will comprise of four rounds, one brainstorming round, to formulate the consensus survey, and three rounds to attempt to obtain consensus.
In each round a questionnaire comprising of statements and questions regarding respiratory oscillometry will be sent to participants in the Delphi study electronically using SurveyLet, an online survey platform. Participants will respond anonymously to the survey questions, indicating their level of agreement or disagreement with each statement or question. Participants will be given 4 weeks to complete each round of the Delphi study.
Questions and statements will be repeated in subsequent rounds until the predefined level of consensus is met or the maximum number of rounds is achieved (limited to a maximum of 3 rounds). Aggregated results for each statement or question, including distribution of results and consensus status, will be provided to participants after each round to facilitate informed decisions in subsequent rounds.
Read the detailed description
Study procedures:
The Delphi study will comprise of four rounds, one brainstorming round and three rounds to attempt to obtain consensus.
A series of anonymous questionnaires will be administered to a panel of experts and respiratory specialists familiar with oscillometry testing.
Phase one: Brainstorming to develop survey questionnaire.
The initial brainstorming questionnaire will be developed by the Steering Committee, based on the published literature and clinical practice. The brainstorming questionnaire will be circulated to a selected group of respiratory specialists who are known experts in respiratory oscillometry for refinement and testing.
The expert panel will comprise of approximately 10 respiratory specialists who have published papers on respiratory oscillometry. This brainstorming questionnaire will be open in nature and will allow all respondents to propose new statements as well as adjust the proposed statements that are to be evaluated by their peers.
The results of the brainstorming round will be reviewed by the Steering Committee to finalise the questionnaire for the first round of the Delphi study.
Phase two: Attempting to achieve consensus.
To obtain consensus three iterative rounds (Rounds 1-3) will be undertaken. In each round a questionnaire comprising of statements and questions regarding respiratory oscillometry will be sent to all participants in the Delphi study electronically using SurveyLet, an online survey platform utilising the Delphi technique.
The initial questionnaire for use in Round 1, will be the survey developed in the brainstorming round.
There will be a range of statement types used to ascertain consensus, including:
- Agreement with statements ranked using a six-point scale (Agree Strongly', ''Agree Moderately', Agree Slightly', 'Disagree Slightly', 'Disagree Strongly', ''Disagree Moderately').
- Agreement on importance/clinical utility of various oscillometry parameters using a ranking process.
- Agreement on defining values (cut-offs) for clinically relevant changes for the various oscillometry parameters.
Participants will be encouraged to provide free text comments after each statement or question and these comments will be reviewed by the Steering Committee to determine if the questionnaire needs revision prior to the next survey round.
Questions and statements will be repeated in subsequent rounds until the predefined level of consensus is met or the maximum number of rounds is achieved (limited to a maximum of 3 rounds).
Aggregated results for each statement or question, including distribution of results and consensus status, will be provided to participants after each round to facilitate informed decisions in subsequent rounds.
Participants will be given 4 weeks to complete each round of the Delphi study. During a Delphi study, participants with a minority opinion can become discouraged and drop out of the study, potentially resulting in an overestimation of consensus.
At the commencement of the study, participants will be sent an email with an encrypted personalised secure link (to the study questionnaire). This secure link means that each participant can only view their own data and the aggregated data shared in study rounds 2 and 3. No study participant nor the lead investigators can see the individual responses of any other participant. Access to subsequent study rounds is also via the encrypted secure link or via the participant login into the SurveyLet platform.
In this study, consensus is achieved when ≥ 70% of the participants give the same answer for any question or statement.
For questions and statements that are assessed using a 6-point agreement scale, consensus is achieved when ≥ 70% of participants either:
- 'Agree Strongly' or ''Agree Moderately'
- 'Agree Slightly' or ''Disagree Slightly'
- 'Disagree Strongly' or ''Disagree Moderately'
For questions and statements that are assessed using a ranking process, consensus is achieved when ≥ 70% of participants give that ranking.
For questions and statements that are assessed using a defined value, consensus is achieved when ≥ 70% of participants give the same value.
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Being tested
- Respiratory oscillometry
- Keywords
- Respiratory oscillometry, Impulse oscillometry, Forced oscillation technique
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory oscillometryDiagnostic test
This a Delphi study where we are obtaining expert opinion and input on the use of respiratory oscillometry (a diagnostic respiratory test) in the assessment and management of patients with asthma or chronic obstructive pulmonary disease. The participants are respiratory specialists/pulmonologists. They are sharing their insights into the clinical use of respiratory oscillometry via a series of online surveys. The Delphi process is used in an attempt to achieve consensus as to how respiratory oscillometry is used in clinical practice. As such there is no intervention being used on the study participants, but they are sharing insights on how the respiratory test is used in their clinical practice in order to obtain consensus on this use.
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of which respiratory oscillometry parameters (resistance, [R5, R20, R5-R20], reactance [X5, delta X5] or reactance area [AX]) are used to guide clinical management of asthma or COPD as determined by expert consensus using a ranking scale.
Participants are asked to rank in order of clinical importance the different respiratory oscillometry parameters (R5, R20, X5, AX, R5-R20, delta X5) from 1 to 6
Consensus is achieved when ≥ 70% of the participants give the same ranking order within an individual round of the Delphi study. If consensus is not achieved, aggregated data from the previous round is shared and the participants are asked to provide their ranking again.
Measured: When consensus is achieved within an individual Delphi round or through to study end, up to 1 year
Identification of cut-off values used for respiratory oscillometry parameters (R5, X5, AX, R5-R20) to define an abnormal test result as determined by expert consensus using a 6-point categorical scale (Agree strongly to Disagree strongly)
Cut-off values used to define abnormality are proposed for each parameter (R5, X5, AX, and R5-R20) and the participants/experts are asked for their level of agreement with the proposed cut-off value being assessed.
An example of the type of statement used for this component of the survey is as follows:
For R5, a result with a z-score > 1.64 is considered abnormal.
- Agree Strongly B. Agree Moderately C. Agree Slightly D. Disagree Slightly E. Disagree Moderately F. Disagree Strongly
Consensus is achieved when ≥ 70% of the participants give the same level of agreement for each statement within an individual round of the Delphi study. If consensus is not achieved, aggregated data from the previous round is shared and the participants are asked to provide their level of agreement again.
Measured: When consensus is achieved within an individual Delphi round or through to study end, up to 1 year
Secondary outcomes (2)
Identification of cut-off values used for respiratory oscillometry parameters (R5, X5, and AX) to define a bronchodilator response as determined by expert consensus using a 6-point categorical scale (Agree strongly to Disagree strongly)
Cut-off values used to define a bronchodilator response are proposed for each parameter (R5, X5, and AX) and the participants/experts are asked for their level of agreement with the proposed cut-off value being assessed.
An example of the type of statement used for this component of the survey is:
For R5, a result with a z-score > 1.4 is considered to be a significant bronchodilator response.
- Agree Strongly B. Agree Moderately C. Agree Slightly D. Disagree Slightly E. Disagree Moderately F. Disagree Strongly
Consensus is achieved when ≥ 70% of the participants give the same level of agreement for each statement within an individual round of the Delphi study. If consensus is not achieved, aggregated data from the previous round is shared and the participants are asked to provide their level of agreement again.
Measured: When consensus is achieved within an individual Delphi round or through to study end, up to 1 year
Identification of cut-off values used for oscillometry parameters (R5, X5, AX, R5-R20) to define a significant clinical change between visits as determined by expert consensus using a 6-point categorical scale (Agree strongly to Disagree strongly)
Cut-off values used to define a significant clinical change between visits are proposed for each parameter (R5, X5, AX and R5-R20) and the participants/experts are asked for their level of agreement with the proposed cut-off value being assessed.
An example of the type of statement used for this component of the survey is:
For R5, a result with a z-score > 0.5 is considered a significant change between visits.
- Agree Strongly B. Agree Moderately C. Agree Slightly D. Disagree Slightly E. Disagree Moderately F. Disagree Strongly
Consensus is achieved when ≥ 70% of the participants give the same level of agreement for each statement within an individual round of the Delphi study. If consensus is not achieved, aggregated data from the previous round is shared and the participants are asked to provide their level of agreement again.
Measured: When consensus is achieved within an individual Delphi round or through to study end, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scius Healthcare Solutions Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chiesi Australia
- Responsible party
- Sponsor
- Investigators
- Li Ping Chung, MBBS, Principal investigator, Fiona Stanley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06313372
- Sponsor's protocol ID
- CA2085
- Status last verified
- Mar 2024
- First submitted
- 26 Feb 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared with other study participants as a fundamental aspect of a Delphi study is that any data shared during the Delphi process is anonymous and therefore professional reputation does not introduce bias into the achievement of consensus. Anonymized (excluding individual demographics that jeopardise participant privacy) aggregated data will be shared on an appropriate public platform at the time of publication.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interpreting Respiratory Oscillometry in Adult Asthma and COPD: a Delphi Study
- ClinicalTrials.gov ID
- NCT06313372
- Acronym / sponsor ID
- CA2085
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease
- Keywords
- Respiratory oscillometry, Impulse oscillometry, Forced oscillation technique
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Scius Healthcare Solutions Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Chiesi Australia
- Study start
- Mar 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an international Delphi study to consolidate expert consensus on the use of respiratory oscillometry in the management of adult patients with asthma or chronic obstructive pulmonary disease (COPD).
The primary objective of the Delphi study is to aid the interpretation of respiratory oscillometry in clinical practice amongst adult patients with asthma or COPD. This will be achieved by obtaining expert consensus on:
- Which parameters are used in clinical practice for impulse oscillometry (IOS) and for forced oscillation technique (FOT) devices.
- What cut-offs can be used for each parameter to guide clinical practice in the management of adult patients with asthma and COPD.
This study is based on the Delphi methodology. The Delphi study will comprise of four rounds, one brainstorming round, to formulate the consensus survey, and three rounds to attempt to obtain consensus.
In each round a questionnaire comprising of statements and questions regarding respiratory oscillometry will be sent to participants in the Delphi study electronically using SurveyLet, an online survey platform. Participants will respond anonymously to the survey questions, indicating their level of agreement or disagreement with each statement or question. Participants will be given 4 weeks to complete each round of the Delphi study.
Questions and statements will be repeated in subsequent rounds until the predefined level of consensus is met or the maximum number of rounds is achieved (limited to a maximum of 3 rounds). Aggregated results for each statement or question, including distribution of results and consensus status, will be provided to participants after each round to facilitate informed decisions in subsequent rounds.
Detailed description
Study procedures:
The Delphi study will comprise of four rounds, one brainstorming round and three rounds to attempt to obtain consensus.
A series of anonymous questionnaires will be administered to a panel of experts and respiratory specialists familiar with oscillometry testing.
Phase one: Brainstorming to develop survey questionnaire.
The initial brainstorming questionnaire will be developed by the Steering Committee, based on the published literature and clinical practice. The brainstorming questionnaire will be circulated to a selected group of respiratory specialists who are known experts in respiratory oscillometry for refinement and testing.
The expert panel will comprise of approximately 10 respiratory specialists who have published papers on respiratory oscillometry. This brainstorming questionnaire will be open in nature and will allow all respondents to propose new statements as well as adjust the proposed statements that are to be evaluated by their peers.
The results of the brainstorming round will be reviewed by the Steering Committee to finalise the questionnaire for the first round of the Delphi study.
Phase two: Attempting to achieve consensus.
To obtain consensus three iterative rounds (Rounds 1-3) will be undertaken. In each round a questionnaire comprising of statements and questions regarding respiratory oscillometry will be sent to all participants in the Delphi study electronically using SurveyLet, an online survey platform utilising the Delphi technique.
The initial questionnaire for use in Round 1, will be the survey developed in the brainstorming round.
There will be a range of statement types used to ascertain consensus, including:
- Agreement with statements ranked using a six-point scale (Agree Strongly', ''Agree Moderately', Agree Slightly', 'Disagree Slightly', 'Disagree Strongly', ''Disagree Moderately').
- Agreement on importance/clinical utility of various oscillometry parameters using a ranking process.
- Agreement on defining values (cut-offs) for clinically relevant changes for the various oscillometry parameters.
Participants will be encouraged to provide free text comments after each statement or question and these comments will be reviewed by the Steering Committee to determine if the questionnaire needs revision prior to the next survey round.
Questions and statements will be repeated in subsequent rounds until the predefined level of consensus is met or the maximum number of rounds is achieved (limited to a maximum of 3 rounds).
Aggregated results for each statement or question, including distribution of results and consensus status, will be provided to participants after each round to facilitate informed decisions in subsequent rounds.
Participants will be given 4 weeks to complete each round of the Delphi study. During a Delphi study, participants with a minority opinion can become discouraged and drop out of the study, potentially resulting in an overestimation of consensus.
At the commencement of the study, participants will be sent an email with an encrypted personalised secure link (to the study questionnaire). This secure link means that each participant can only view their own data and the aggregated data shared in study rounds 2 and 3. No study participant nor the lead investigators can see the individual responses of any other participant. Access to subsequent study rounds is also via the encrypted secure link or via the participant login into the SurveyLet platform.
In this study, consensus is achieved when ≥ 70% of the participants give the same answer for any question or statement.
For questions and statements that are assessed using a 6-point agreement scale, consensus is achieved when ≥ 70% of participants either:
- 'Agree Strongly' or ''Agree Moderately'
- 'Agree Slightly' or ''Disagree Slightly'
- 'Disagree Strongly' or ''Disagree Moderately'
For questions and statements that are assessed using a ranking process, consensus is achieved when ≥ 70% of participants give that ranking.
For questions and statements that are assessed using a defined value, consensus is achieved when ≥ 70% of participants give the same value.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants in the Delphi study will be respiratory specialists with expertise in the application of respiratory oscillometry in clinical practice and who routinely use respiratory oscillometry in clinical practice. Clinical use is defined as respiratory specialists who order and/or interpret respiratory oscillometry in day-to-day clinical practice.
Key inclusion criteria (2 listed)
- Respiratory specialist in active clinical practice ≥ 12 months.
- Use respiratory oscillometry ≥ 2 tests per week
Key exclusion criteria (4 listed)
- Only use respiratory oscillometry when participating in clinical trials
- Employee or stockholder of pharmaceutical company
- Employee or stockholder of oscillometry manufacturer
- Employee or stockholder of tobacco/vaping companies.
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 |
|---|---|---|
| Respiratory oscillometryThis a Delphi study where we are obtaining expert opinion and input on the use of respiratory oscillometry (a diagnostic respiratory test) in the assessment and management of patients with asthma or chronic obstructive pulmonary disease. The participants are respiratory specialists/pulmonologists. They are sharing their insights into the clinical use of respiratory oscillometry via a series of online surveys. The Delphi process is used in an attempt to achieve consensus as to how respiratory oscillometry is used in clinical practice. As such there is no intervention being used on the study participants, but they are sharing insights on how the respiratory test is used in their clinical practice in order to obtain consensus on this use. | Diagnostic test | – |
Primary outcome
Identification of which respiratory oscillometry parameters (resistance, [R5, R20, R5-R20], reactance [X5, delta X5] or reactance area [AX]) are used to guide clinical management of asthma or COPD as determined by expert consensus using a ranking scale.
Time frame: When consensus is achieved within an individual Delphi round or through to study end, up to 1 year
Participants are asked to rank in order of clinical importance the different respiratory oscillometry parameters (R5, R20, X5, AX, R5-R20, delta X5) from 1 to 6 Consensus is achieved when ≥ 70% of the participants give the same ranking order within an individual round of the Delphi study. If consensus is not achieved, aggregated data from the previous round is shared and the participants are asked to provide their ranking again.
Identification of cut-off values used for respiratory oscillometry parameters (R5, X5, AX, R5-R20) to define an abnormal test result as determined by expert consensus using a 6-point categorical scale (Agree strongly to Disagree strongly)
Time frame: When consensus is achieved within an individual Delphi round or through to study end, up to 1 year
Cut-off values used to define abnormality are proposed for each parameter (R5, X5, AX, and R5-R20) and the participants/experts are asked for their level of agreement with the proposed cut-off value being assessed. An example of the type of statement used for this component of the survey is as follows: For R5, a result with a z-score > 1.64 is considered abnormal. A. Agree Strongly B. Agree Moderately C. Agree Slightly D. Disagree Slightly E. Disagree Moderately F. Disagree Strongly Consensus is achieved when ≥ 70% of the participants give the same level of agreement for each statement within an individual round of the Delphi study. If consensus is not achieved, aggregated data from the previous round is shared and the participants are asked to provide their level of agreement again.
2 secondary outcomes
Identification of cut-off values used for respiratory oscillometry parameters (R5, X5, and AX) to define a bronchodilator response as determined by expert consensus using a 6-point categorical scale (Agree strongly to Disagree strongly)
Time frame: When consensus is achieved within an individual Delphi round or through to study end, up to 1 year
Identification of cut-off values used for oscillometry parameters (R5, X5, AX, R5-R20) to define a significant clinical change between visits as determined by expert consensus using a 6-point categorical scale (Agree strongly to Disagree strongly)
Time frame: When consensus is achieved within an individual Delphi round or through to study end, up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No. No individual participant data will be shared with other study participants as a fundamental aspect of a Delphi study is that any data shared during the Delphi process is anonymous and therefore professional reputation does not introduce bias into the achievement of consensus. Anonymized (excluding individual demographics that jeopardise participant privacy) aggregated data will be shared on an appropriate public platform at the time of publication.
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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.
Li Ping Chung, MBBS principal investigator
Fiona Stanley Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Chronic Obstructive Pulmonary Disease, run by Scius Healthcare Solutions Pty Ltd.
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 4 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 18 Mar 2024. 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?
Contact George M Krassas, B Pharm (+61400950086, george@scius.com.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of which respiratory oscillometry parameters (resistance, [R5, R20, R5-R20], reactance [X5, delta X5] or reactance area [AX]) are used to guide clinical management of asthma or COPD as determined by expert consensus using a ranking scale. (time frame: When consensus is achieved within an individual Delphi round or through to study end, up to 1 year). The study lists 2 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 18 Mar 2024.