Validation of Structured Light Plethysmography: Asthma

NCT02543333 | Completed

• 1 other identifier: PMC-T3D-002/2
• Study Type: observational
• Target: 183
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma

Keywords

Acute Asthma,

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline

Secondary Outcomes (2)

• Change from Baseline in Forced Expiratory Volume in 1 second (FEV1) after Bronchodilator Reversibility Test

  Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)

• Change from Baseline in Forced Vital Capacity (FVC) after Bronchodilator Reversibility Test

  Baseline and 15 minutes after bronchodilator reversibility test (in asthma patients)

Study Arms (3)

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

Eligibility Criteria

• Age: 2 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Aged between 2 and 80 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Pneumacare Ltd: lead
• Cambridge University Hospitals NHS Foundation Trust: collaborator
• University Hospitals of North Midlands NHS Trust: collaborator
• Keele University: collaborator

Study Sites (2)

Cambridge University Hospitals Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

Royal Stoke University Hospital

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 15994402 BACKGROUND

• 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.

  PMID: 16055882 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 6701820 BACKGROUND

• 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.

  PMID: 29932498 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Richard Iles, MD

  Cambridge University Hospitals Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: September 7, 2015
• Study Start: July 1, 2013
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: July 10, 2018

Record last verified: 2018-07

Locations

GB (2)