Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-30 @ 5:24 AM
Study NCT ID:
NCT02543333
Status:
COMPLETED
Last Update Posted:
2018-07-10
First Post:
2015-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Structured Light Plethysmography: Asthma
Sponsor:
Pneumacare Ltd
Organization:
Study Overview
Official Title:
Validation of Structured Light Plethysmography: Pre- and Post- Bronchodilator Challenge
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SLPBD
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: