AsthmaSLPBDNCT02543333
Validation of Structured Light Plethysmography: Asthma
An observational study of Asthma, run by Pneumacare Ltd at 2 sites in United Kingdom.
Trial summary
Validation of Structured Light Plethysmography (SLP) in patients with asthma, in patients with acute asthma; an observational study in healthy participants and during patients' clinical investigation of broncho-reversibility in the asthma groups. Read more about this study
- Who is it for?
- Ages 2 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 183 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jul 2013to Jul 2016
- 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 2 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 100 participants between the ages of 2 and 80 with stable asthma who are undergoing routine clinical investigation of broncho-reversibilty. 100 participants between the ages of 2 and 80 with acute asthma who are undergoing routine clinical investigation of broncho-reversibilty. 100 participants between the ages of 2 and 80 with no history of respiratory disease ('Normal'). These participants will not undergo a bronchodilator challenge.
Who may be able to join
- Aged between 2 and 80 years
Who cannot join
- Patients with significant co morbidities resulting in clinical instability (assessed by the clinician at screening only):
- obstructive sleep apnea, Apnoea hypopnoea index > 30 (if known)
- An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in the study
- BMI > 40
- Inability to consent/comply with trial protocol
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Cambridge University Hospitals Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, ST4 6QG
About this study
Official title: Validation of Structured Light Plethysmography: Pre- and Post- Bronchodilator Challenge
Validation of Structured Light Plethysmography (SLP) in patients with asthma, in patients with acute asthma; an observational study in healthy participants and during patients' clinical investigation of broncho-reversibility in the asthma groups.
Read the detailed description
A non-randomised observational study to validate Structured Light Plethysmography in three groups of participants: those with stable asthma and those with acute asthma, who are undergoing routine clinical investigation of broncho-reversibility using spirometry. We will also observe a normal healthy group who will receive no clinical intervention. SLP data capture and spirometry (as part of the patients clinical care) will be performed before and after a Bronchodilator reversibility test which is part of the patients normal clinical care (except in the normal healthy group where no bronchodilator will be given). The data collected from this study will allow us to examine the effect of bronchodilators on breathing patterns in these patients and also compare breathing patterns in asthma patients to those in healthy individuals.
The participant will wear a plain white t-shirt. Alternatively, the measurement can be taken on bare skin or with the participant (if female) wearing a plain material white bra. The participant is asked to sit down on a chair or lie down with their neck in a neutral position and their back as straight as possible in front of the SLP device (Thora-3Di, Pneumacare Ltd). The projector is lined up to project the grid of light over the participant's chest and upper abdomen. and will be instructed to perform a period of 5 minutes of tidal breathing, They will otherwise be asked to remain as still as possible throughout the measurement. During the sequence of breathing, thoracoabdominal wall movements will be captured by the device.
participant on completion of their Bronchodilator Challenge within the Lung Function Department or clinic
The SLP measurement is repeated on completion of their Bronchodilator reversibility test within the Lung Function Department or clinic.
- Conditions
- Asthma
- Keywords
- Acute Asthma,
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthma | Patients attending outpatient clinic as part of their clinical care who have FEV1 less than 80% of predicted and are referred by their clinician for a bronchodilator test | |
| Acute Asthma | Inpatients admitted for an acute asthma exacerbation | |
| Normal | Participants with no current or previous diagnosis of a respiratory condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in SLP Parameters after Bronchodilator Reversibility Test
SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing.
Measured: Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)
Difference in SLP Parameters between Asthma Patients and Healthy Subjects
SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing.
Measured: Baseline
Secondary outcomes (2)
Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) after Bronchodilator Reversibility Test
Measurement of FEV1 before and after bronchodilator
Measured: Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)
Change from Baseline in Forced Vital Capacity (FVC) after Bronchodilator Reversibility Test
Measurement of FEV1 before and after bronchodilator
Measured: Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startJul 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pneumacare Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, University Hospitals of North Midlands NHS Trust, Keele University
- Responsible party
- Sponsor
- Investigators
- Richard Iles, MD, Principal investigator, Cambridge University Hospitals Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543333
- Sponsor's protocol ID
- PMC-T3D-002/2
- Acronym
- SLPBD
- Status last verified
- Jul 2018
- First submitted
- 28 Aug 2015
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Miller 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 15994402Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, 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. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
PubMed 16055882de Boer WH, Lasenby J, Cameron J, Wareham R, Ahmad S, Roach C, Hills W, Iles R. SLP: a zero-contact non-invasive method for pulmonary function testing. In: Labrosse F, Zwiggelaar R, Liu Y, Tiddeman B, eds, Proceedings of the British Machine Vision Conference. BMVA Press, 2010; pp 85.1-85.12
Morgan MD, Gourlay AR, Denison DM. An optical method of studying the shape and movement of the chest wall in recumbent patients. Thorax. 1984 Feb;39(2):101-6. doi: 10.1136/thx.39.2.101.
PubMed 6701820Hmeidi H, Motamedi-Fakhr S, Chadwick EK, Gilchrist FJ, Lenney W, Iles R, Wilson RC, Alexander J. Tidal breathing parameters measured by structured light plethysmography in children aged 2-12 years recovering from acute asthma/wheeze compared with healthy children. Physiol Rep. 2018 Jun;6(12):e13752. doi: 10.14814/phy2.13752.
PubMed 29932498
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Structured Light Plethysmography: Pre- and Post- Bronchodilator Challenge
- ClinicalTrials.gov ID
- NCT02543333
- Acronym / sponsor ID
- SLPBD / PMC-T3D-002/2
- Conditions
- Asthma
- Keywords
- Acute Asthma,
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Pneumacare LtdIndustry (pharma, biotech, devices)
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, University Hospitals of North Midlands NHS Trust, Keele University
- Study start
- Jul 2013 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 7 Sep 2015 (estimated)
- 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.
Validation of Structured Light Plethysmography (SLP) in patients with asthma, in patients with acute asthma; an observational study in healthy participants and during patients' clinical investigation of broncho-reversibility in the asthma groups.
Detailed description
A non-randomised observational study to validate Structured Light Plethysmography in three groups of participants: those with stable asthma and those with acute asthma, who are undergoing routine clinical investigation of broncho-reversibility using spirometry. We will also observe a normal healthy group who will receive no clinical intervention. SLP data capture and spirometry (as part of the patients clinical care) will be performed before and after a Bronchodilator reversibility test which is part of the patients normal clinical care (except in the normal healthy group where no bronchodilator will be given). The data collected from this study will allow us to examine the effect of bronchodilators on breathing patterns in these patients and also compare breathing patterns in asthma patients to those in healthy individuals.
The participant will wear a plain white t-shirt. Alternatively, the measurement can be taken on bare skin or with the participant (if female) wearing a plain material white bra. The participant is asked to sit down on a chair or lie down with their neck in a neutral position and their back as straight as possible in front of the SLP device (Thora-3Di, Pneumacare Ltd). The projector is lined up to project the grid of light over the participant's chest and upper abdomen. and will be instructed to perform a period of 5 minutes of tidal breathing, They will otherwise be asked to remain as still as possible throughout the measurement. During the sequence of breathing, thoracoabdominal wall movements will be captured by the device.
participant on completion of their Bronchodilator Challenge within the Lung Function Department or clinic
The SLP measurement is repeated on completion of their Bronchodilator reversibility test within the Lung Function Department or clinic.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Asthma | – | –Patients attending outpatient clinic as part of their clinical care who have FEV1 less than 80% of predicted and are referred by their clinician for a bronchodilator test |
| Acute Asthma | – | –Inpatients admitted for an acute asthma exacerbation |
| Normal | – | –Participants with no current or previous diagnosis of a respiratory condition |
Who may qualify
- Ages
- 2 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 100 participants between the ages of 2 and 80 with stable asthma who are undergoing routine clinical investigation of broncho-reversibilty. 100 participants between the ages of 2 and 80 with acute asthma who are undergoing routine clinical investigation of broncho-reversibilty. 100 participants between the ages of 2 and 80 with no history of respiratory disease ('Normal'). These participants will not undergo a bronchodilator challenge.
Key inclusion criteria (1 listed)
- Aged between 2 and 80 years
Key exclusion criteria (5 listed)
- Patients with significant co morbidities resulting in clinical instability (assessed by the clinician at screening only):
- obstructive sleep apnea, Apnoea hypopnoea index > 30 (if known)
- An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to participate in the study
- BMI > 40
- Inability to consent/comply with trial protocol
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
Change from Baseline in SLP Parameters after Bronchodilator Reversibility Test
Time frame: Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)
SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing.
Difference in SLP Parameters between Asthma Patients and Healthy Subjects
Time frame: Baseline
SLP breathing parameters derived from the movement of the thoracoabdominal (TA) wall during tidal breathing.
2 secondary outcomes
Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) after Bronchodilator Reversibility Test
Time frame: Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)
Change from Baseline in Forced Vital Capacity (FVC) after Bronchodilator Reversibility Test
Time frame: Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)
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 10 Jul 2018.
- 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 16055882Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, 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. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.
- Backgroundde Boer WH, Lasenby J, Cameron J, Wareham R, Ahmad S, Roach C, Hills W, Iles R. SLP: a zero-contact non-invasive method for pulmonary function testing. In: Labrosse F, Zwiggelaar R, Liu Y, Tiddeman B, eds, Proceedings of the British Machine Vision Conference. BMVA Press, 2010; pp 85.1-85.12
- Background: PubMed 6701820Morgan MD, Gourlay AR, Denison DM. An optical method of studying the shape and movement of the chest wall in recumbent patients. Thorax. 1984 Feb;39(2):101-6. doi: 10.1136/thx.39.2.101.
- Derived from this study: PubMed 29932498Hmeidi H, Motamedi-Fakhr S, Chadwick EK, Gilchrist FJ, Lenney W, Iles R, Wilson RC, Alexander J. Tidal breathing parameters measured by structured light plethysmography in children aged 2-12 years recovering from acute asthma/wheeze compared with healthy children. Physiol Rep. 2018 Jun;6(12):e13752. doi: 10.14814/phy2.13752.
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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.
Richard Iles, MD principal investigator
Cambridge University Hospitals Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Pneumacare Ltd at 2 sites in United Kingdom.
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 5 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 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Change from Baseline in SLP Parameters after Bronchodilator Reversibility Test (time frame: Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)). 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?
On the ClinicalTrials.gov record for NCT02543333, which also lists 5 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 10 Jul 2018.