Clinical trial NCT02543333: Validation of Structured Light Plethysmography: Asthma
Official title: Validation of Structured Light Plethysmography: Pre- and Post- Bronchodilator Challenge
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Acute Asthma,
Lead sponsor: Pneumacare Ltd
Sponsor class: INDUSTRY
Collaborators: name: Cambridge University Hospitals NHS Foundation Trust
name: University Hospitals of North Midlands NHS Trust
name: Keele University
First posted: 2015-09-07
Enrollment: 183
Sex: ALL
Minimum age (years): 2
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Aged between 2 and 80 years

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from Baseline in SLP Parameters after Bronchodilator Reversibility Test
timeFrame: Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)
measure: Difference in SLP Parameters between Asthma Patients and Healthy Subjects
timeFrame: Baseline
Secondary outcomes:
measure: Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) after Bronchodilator Reversibility Test
timeFrame: Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)
measure: Change from Baseline in Forced Vital Capacity (FVC) after Bronchodilator Reversibility Test
timeFrame: Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals Foundation Trust
state: Cambridgeshire
city: Stoke on Trent
country: United Kingdom
facility: Royal Stoke University Hospital
state: Staffordshire
Study officials:
affiliation: Cambridge University Hospitals Trust
name: Richard Iles, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Miller 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.
citation: de 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
citation: 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.
citation: Hmeidi 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.