AsthmaNCT06272773
Forced Oscillation and Breathing Pattern in Asthma
An observational study of Asthma, run by Karl Sylvester.
Trial summary
Asthma is a chronic respiratory disease characterised by airway inflammation, bronchoconstriction, and airway hyperresponsiveness. Accurate and reliable assessment of lung function is crucial in diagnosing and monitoring asthma. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Asthma
- What is being tested?
- Forced Oscillation Test
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Mar 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with physician-diagnosed asthma and demonstrable obstructive lung disease.
Who may be able to join
- Age > 18years Confirmed diagnosis of asthma Evidence of obstructive lung disease, FEV1/forced vital capacity (FVC) <lower limit of normal (LLN)
Who cannot join
- Unstable/Uncontrolled asthma, as designated by the patient's consultant Known breathing pattern disorder Inability to cooperate with instructions Refusal to give informed consent
About this study
Official title: The Influence of Breathing Pattern on Measurement of Forced Oscillation in Patients With Asthma
Asthma is a chronic respiratory disease characterised by airway inflammation, bronchoconstriction, and airway hyperresponsiveness. Accurate and reliable assessment of lung function is crucial in diagnosing and monitoring asthma. The forced oscillation technique (FOT) is a non-invasive method that has gained attention in recent years as a valuable tool for evaluating respiratory mechanics in asthma.
FOT involves applying small amplitude oscillations at various frequencies to the respiratory system and measuring the resulting pressure and flow responses. These measurements provide valuable insights into the mechanical properties of the airways, including resistance, compliance, and reactance. FOT offers several advantages over traditional spirometry, such as its ability to assess peripheral airway function, sensitivity to small airway abnormalities, and ease of use, particularly in young children or individuals with severe airflow limitation. FOT also allows for assessment of respiratory mechanics in individuals who may struggle with performing spirometry manoeuvres.
Read more
However, it is unclear whether a change in breathing pattern in patients with obstructive lung disease impacts the assessment of a response to treatment utilising FOT.
Several studies have demonstrated a high prevalence of Breathing Pattern Disorders (BPDs) in individuals with asthma. These findings suggest that BPDs may be common in asthma and could contribute to the manifestation and severity of respiratory symptoms. Evidence suggests that BPDs can adversely affect pulmonary function in individuals with asthma. One study demonstrated that children with asthma and dysfunctional breathing exhibited significantly reduced forced expiratory volume in one second (FEV1) compared to asthmatics without BPD. This suggests that abnormal breathing patterns may contribute to airflow limitation in asthma, leading to decreased lung function.
We therefore wish to determine the impact of different breathing frequencies on parameters measured using FOT in patients diagnosed with asthma and concomitant obstructive lung function abnormality.
Read the detailed description
Asthma is a chronic respiratory disease characterised by airway inflammation, bronchoconstriction, and airway hyperresponsiveness. Accurate and reliable assessment of lung function is crucial in diagnosing and monitoring asthma. The forced oscillation technique (FOT) is a non-invasive method that has gained attention in recent years as a valuable tool for evaluating respiratory mechanics in asthma.
FOT involves applying small amplitude oscillations at various frequencies to the respiratory system and measuring the resulting pressure and flow responses. These measurements provide valuable insights into the mechanical properties of the airways, including resistance, compliance, and reactance. FOT offers several advantages over traditional spirometry, such as its ability to assess peripheral airway function, sensitivity to small airway abnormalities, and ease of use, particularly in young children or individuals with severe airflow limitation. FOT also allows for assessment of respiratory mechanics in individuals who may struggle with performing spirometry manoeuvres.
Numerous studies have investigated the utility of FOT in diagnosing asthma. For instance, Smith et al. (2018) conducted a study on 100 adults with suspected asthma and found that FOT parameters, such as total respiratory resistance and respiratory system reactance, demonstrated good diagnostic accuracy compared to spirometry. Similarly, Andersson et al. (2020) evaluated the diagnostic performance of FOT in children with asthma and reported that FOT parameters correlated well with markers of airway inflammation, suggesting its potential for identifying asthmatic phenotypes.
In addition to its diagnostic value, FOT has shown promise in monitoring asthma control and assessing treatment response. A study by Van der Wiel et al. (2019) investigated the use of FOT in adults with mild to moderate asthma and found that changes in FOT parameters, such as frequency dependence of resistance and reactance, were sensitive to improvements in lung function following treatment. Similarly, Song et al. (2021) conducted a systematic review and meta-analysis and reported that FOT parameters exhibited significant changes in response to different asthma treatments, supporting its utility as an outcome measure in clinical trials.
However, it is unclear whether a change in breathing pattern in patients with obstructive lung disease impacts the assessment of a response to treatment utilising FOT. Several studies have demonstrated a high prevalence of BPDs in individuals with asthma. In a study by Thomas et al. (2018), 54% of asthma patients exhibited abnormal breathing patterns, characterized by upper chest breathing, reduced diaphragmatic excursion, and increased accessory muscle use. These findings suggest that BPDs may be common in asthma and could contribute to the manifestation and severity of respiratory symptoms. Evidence suggests that BPDs can adversely affect pulmonary function in individuals with asthma. A study by Porges et al. (2019) demonstrated that children with asthma and dysfunctional breathing exhibited significantly reduced forced expiratory volume in one second (FEV1) compared to asthmatics without BPD. This suggests that abnormal breathing patterns may contribute to airflow limitation in asthma, leading to decreased lung function.
Howlett-Foster et al (2022) demonstrated no significant difference in FOT parameters across multiple breathing frequencies in healthy young adults. However, in obstructive lung disease the airway luminal size is smaller due to airway inflammation, excessive smooth muscle contraction and mucus plugging. Based on the Hagen-Poiseuille equation halving the luminal radius increases airways resistance 16-fold. In addition, based on the law of Bernoulli, this smaller luminal size will increase the velocity of air through the airways, reducing airway pressure and leading to a tendency of the airways to narrow further. Therefore, in asthmatic patients a change in breathing frequency may lead to an increase in airway velocity, a reduction in luminal size and hence an increase in airway resistance. A change in breathing pattern between measurements, particularly following treatment administration, may over or underestimate treatment response if the response is measured using FOT and may not be due to the treatment itself.
We therefore wish to determine the impact of different breathing frequencies on parameters measured using FOT in patients diagnosed with asthma and concomitant obstructive lung function abnormality.
- Conditions
- Asthma
- Being tested
- Forced Oscillation Test
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forced Oscillation TestDevice
Participant will breathe normally through the device which sends different frequency sounds into the airways, monitoring the response coming back from central and peripheral airways to calculate airway impedence, reactance and resistance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in airway resistance at 5 Hertz (Hz) and 19Hz
To assess the affect of a change in breathing frequency on FOT measurements, specifically airway resistance at 5Hz and 19Hz, in patients with a known diagnosis of asthma.
Measured: 20 mins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionMar 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karl Sylvester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karl Sylvester, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272773
- Sponsor's protocol ID
- IRAS Ref: 333663
- Status last verified
- Feb 2024
- First submitted
- 16 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Breathing Pattern on Measurement of Forced Oscillation in Patients With Asthma
- ClinicalTrials.gov ID
- NCT06272773
- Acronym / sponsor ID
- IRAS Ref: 333663
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Karl SylvesterUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 22 Feb 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.
Asthma is a chronic respiratory disease characterised by airway inflammation, bronchoconstriction, and airway hyperresponsiveness. Accurate and reliable assessment of lung function is crucial in diagnosing and monitoring asthma. The forced oscillation technique (FOT) is a non-invasive method that has gained attention in recent years as a valuable tool for evaluating respiratory mechanics in asthma.
FOT involves applying small amplitude oscillations at various frequencies to the respiratory system and measuring the resulting pressure and flow responses. These measurements provide valuable insights into the mechanical properties of the airways, including resistance, compliance, and reactance. FOT offers several advantages over traditional spirometry, such as its ability to assess peripheral airway function, sensitivity to small airway abnormalities, and ease of use, particularly in young children or individuals with severe airflow limitation. FOT also allows for assessment of respiratory mechanics in individuals who may struggle with performing spirometry manoeuvres.
However, it is unclear whether a change in breathing pattern in patients with obstructive lung disease impacts the assessment of a response to treatment utilising FOT.
Several studies have demonstrated a high prevalence of Breathing Pattern Disorders (BPDs) in individuals with asthma. These findings suggest that BPDs may be common in asthma and could contribute to the manifestation and severity of respiratory symptoms. Evidence suggests that BPDs can adversely affect pulmonary function in individuals with asthma. One study demonstrated that children with asthma and dysfunctional breathing exhibited significantly reduced forced expiratory volume in one second (FEV1) compared to asthmatics without BPD. This suggests that abnormal breathing patterns may contribute to airflow limitation in asthma, leading to decreased lung function.
We therefore wish to determine the impact of different breathing frequencies on parameters measured using FOT in patients diagnosed with asthma and concomitant obstructive lung function abnormality.
Detailed description
Asthma is a chronic respiratory disease characterised by airway inflammation, bronchoconstriction, and airway hyperresponsiveness. Accurate and reliable assessment of lung function is crucial in diagnosing and monitoring asthma. The forced oscillation technique (FOT) is a non-invasive method that has gained attention in recent years as a valuable tool for evaluating respiratory mechanics in asthma.
FOT involves applying small amplitude oscillations at various frequencies to the respiratory system and measuring the resulting pressure and flow responses. These measurements provide valuable insights into the mechanical properties of the airways, including resistance, compliance, and reactance. FOT offers several advantages over traditional spirometry, such as its ability to assess peripheral airway function, sensitivity to small airway abnormalities, and ease of use, particularly in young children or individuals with severe airflow limitation. FOT also allows for assessment of respiratory mechanics in individuals who may struggle with performing spirometry manoeuvres.
Numerous studies have investigated the utility of FOT in diagnosing asthma. For instance, Smith et al. (2018) conducted a study on 100 adults with suspected asthma and found that FOT parameters, such as total respiratory resistance and respiratory system reactance, demonstrated good diagnostic accuracy compared to spirometry. Similarly, Andersson et al. (2020) evaluated the diagnostic performance of FOT in children with asthma and reported that FOT parameters correlated well with markers of airway inflammation, suggesting its potential for identifying asthmatic phenotypes.
In addition to its diagnostic value, FOT has shown promise in monitoring asthma control and assessing treatment response. A study by Van der Wiel et al. (2019) investigated the use of FOT in adults with mild to moderate asthma and found that changes in FOT parameters, such as frequency dependence of resistance and reactance, were sensitive to improvements in lung function following treatment. Similarly, Song et al. (2021) conducted a systematic review and meta-analysis and reported that FOT parameters exhibited significant changes in response to different asthma treatments, supporting its utility as an outcome measure in clinical trials.
However, it is unclear whether a change in breathing pattern in patients with obstructive lung disease impacts the assessment of a response to treatment utilising FOT. Several studies have demonstrated a high prevalence of BPDs in individuals with asthma. In a study by Thomas et al. (2018), 54% of asthma patients exhibited abnormal breathing patterns, characterized by upper chest breathing, reduced diaphragmatic excursion, and increased accessory muscle use. These findings suggest that BPDs may be common in asthma and could contribute to the manifestation and severity of respiratory symptoms. Evidence suggests that BPDs can adversely affect pulmonary function in individuals with asthma. A study by Porges et al. (2019) demonstrated that children with asthma and dysfunctional breathing exhibited significantly reduced forced expiratory volume in one second (FEV1) compared to asthmatics without BPD. This suggests that abnormal breathing patterns may contribute to airflow limitation in asthma, leading to decreased lung function.
Howlett-Foster et al (2022) demonstrated no significant difference in FOT parameters across multiple breathing frequencies in healthy young adults. However, in obstructive lung disease the airway luminal size is smaller due to airway inflammation, excessive smooth muscle contraction and mucus plugging. Based on the Hagen-Poiseuille equation halving the luminal radius increases airways resistance 16-fold. In addition, based on the law of Bernoulli, this smaller luminal size will increase the velocity of air through the airways, reducing airway pressure and leading to a tendency of the airways to narrow further. Therefore, in asthmatic patients a change in breathing frequency may lead to an increase in airway velocity, a reduction in luminal size and hence an increase in airway resistance. A change in breathing pattern between measurements, particularly following treatment administration, may over or underestimate treatment response if the response is measured using FOT and may not be due to the treatment itself.
We therefore wish to determine the impact of different breathing frequencies on parameters measured using FOT in patients diagnosed with asthma and concomitant obstructive lung function abnormality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with physician-diagnosed asthma and demonstrable obstructive lung disease.
Key inclusion criteria (1 listed)
- Age > 18years Confirmed diagnosis of asthma Evidence of obstructive lung disease, FEV1/forced vital capacity (FVC) <lower limit of normal (LLN)
Key exclusion criteria (1 listed)
- Unstable/Uncontrolled asthma, as designated by the patient's consultant Known breathing pattern disorder Inability to cooperate with instructions Refusal to give informed consent
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 |
|---|---|---|
| Forced Oscillation TestParticipant will breathe normally through the device which sends different frequency sounds into the airways, monitoring the response coming back from central and peripheral airways to calculate airway impedence, reactance and resistance. | Device | – |
Primary outcome
Change in airway resistance at 5 Hertz (Hz) and 19Hz
Time frame: 20 mins
To assess the affect of a change in breathing frequency on FOT measurements, specifically airway resistance at 5Hz and 19Hz, in patients with a known diagnosis of asthma.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Karl Sylvester.
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 22 Feb 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?
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?
Change in airway resistance at 5 Hertz (Hz) and 19Hz (time frame: 20 mins). 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 Feb 2024.