An observational study in Pediatric Respiratory Diseases, sponsored by Guy's and St Thomas' NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 1 Month to 12 Years. Per ClinicalTrials.gov, last updated 2020-02-18.
Sponsored by Guy's and St Thomas' NHS Foundation Trust · Observational
Among 558 studies in Asthma with a site in United Kingdom — 52 open to participants now, 72 under way, 11 of them phase 3. Asthma · United Kingdom.
Among the 558 studies in Asthma with a site in United Kingdom, this one is the 102nd largest by enrollment of the 131 observational ones that give a count, is one of 26 that started in 2018, is one of 131 observational ones, and was the 358th registered.
4,843 studies on the registry are indexed under Asthma; 602 are open to participants now.
Browse Asthma studies →52 of the 558 studies in Asthma with a site in United Kingdom are open now. Recruiting first, the newest first:
Richmond Research Institute · Sites in United Kingdom
Ages 18+
Chiesi Farmaceutici S.p.A. · Sites in United Kingdom
Ages 18–65 · Healthy volunteers
Liverpool Heart and Chest Hospital NHS Foundation Trust · Sites in United Kingdom
Ages 18–110
GlaxoSmithKline · Sites in United Kingdom, United States, Argentina and 1 more country
Ages 18+
University of Leeds · Sites in United Kingdom
Ages 18–70
A study can be open while its sites in United Kingdom have not opened yet or have stopped. Only those recruiting at a site in United Kingdom →
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 146 take children under 18; 104 take healthy volunteers.
This study: 1 Month to 12 Years · all sexes.
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558 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 87 · Phase 2 132 · Phase 3 83 · Phase 4 50
First in 1991; this study’s year is marked. 26 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 57 is below the median of 158 across 1,251 observational studies indexed under Asthma.
Median enrollment 69 across the 427 interventional studies, 149 across the 131 observational. Of the 444 that completed or were terminated, 155 (35%) have results posted.
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320 of 558 have an industry lead sponsor. The 10 most frequent:
Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 295 studies on the registry; 80 are open to participants now.
Guy's and St Thomas' NHS Foundation Trust has 8 studies filed under Asthma — fewer than ten, so there is no comparison to draw.
23 of the studies in Asthma with a site in United Kingdom that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05692180Phase 3AstraZenecaA Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma | 2026-12-23 |
| NCT07645248Phase 3GlaxoSmithKlineA Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a) | 2026-12-28 |
| NCT06473779Phase 3AstraZenecaOpen-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma. | 2027-06-25 |
| NCT07833826University of NottinghamN-WATCH: Nottingham Wheeze Assessment in Tidal Children | 2026-12-31 |
| NCT07488897RIGImmune Inc.RIG 101 Trial in Healthy Adults and Adults With Asthma | 2027-02 |
Add all 23 to your calendar (.ics) → With an account.
Among the 558 studies in Asthma with a site in United Kingdom, from their registry updates:
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Obstructive airways disease is the most common group of acute illnesses leading to hospital treatment in children. This group consists of different age-related diagnoses, such as bronchiolitis in infants or wheezing and asthma in older children. Though these entities overlap with each other, they have common characteristics and the same leading symptom breathing distress.
The investigators aim conduct an observational cohort study to examine if the clinical course of respiratory distress be quantified and the treatment improved in children with acute breathing difficulty using a new non-touch non-invasive SLP measurement device?
Thora3Di is a new CE- and FDA-approved medical device able to measure chest and abdominal wall movements during tidal breathing with a method called structured light plethysmography (SLP). The method is non-touch and non- invasive, it does not need any connection with the child.
One-month- to 12-years-old infants and children are recruited from the paediatric wards at Evelina London Children's hospital. The child lies or sits within the field of vision of the SLP device with their chest and abdomen exposed. A grid pattern of normal light will be projected onto the chest and changes in the format of the grid as the infant or child breathes will be recorded by the SLP device. Data will be collected for each child for 3-5 minutes once in 24 hour periods for 2-10 times during hospital stay.
The aim is to reduce duration of hospital stay by finding predicting parameters for obstructive airways diseases with the new SLP method, and further aim to standardization of treatment strategies, to reduce expenditure.
Cohort pilot study to characterise the chest wall movement during tidal breathing in children admitted due to acute obstructive airways disease, using non-invasive SLP methodology (Thora3DiTM).
The investigators propose to utilise the SLP in children admitted for obstructive airways disease and track progression of their condition during the hospital stay. Focus will be in the SLP output, and investigators aim to 1) quantify the breathing distress and whether this number has an effect on the patient outcome and 2) further aim to see if regional changes in the thoracic-abdominal movement can be recognized by the measurement method.
The data collected from this study will allow investigators to characterise chest wall movements in children with obstructive airways disease and to examine the effect of the treatment on this movement.
Study population
Investigators will aim to recruit:
Locations: Participants are children, in Evelina Children's hospital as a patient due to obstructive airways disease
The eligible children admitted to hospital will be identified at the clinical handovers and after obtaining the parental consent to participate in the study, the first measurements are performed as soon as possible, however within the first 24 hours of admission. The SLP measurements are repeated in 24 hour intervals 2-10 times depending on the duration of hospital stay.
Clinical patient data of age, sex, ethnicity, weight and length will be collected. A member of the clinical / research team (respiratory clinical fellow) collects structured data on the breathing distress using a modified pulmonary index scale for children (mPIS).
Measurement of standard clinical variables, such as respiratory rate, heart rate and oxygen saturation will be made each time the SLP readings are recorded. The measurement will be taken on a bare skin with a white medical adhesive tape to cover any existing medical attachments on thoracic-abdominal region (such as ECG electrodes). Alternatively, measurements can be made if the child is wearing a close fitting white garment without any creases (such as a babygrow).
A structured light pattern will be projected onto the chest and abdominal wall and the movement of this pattern as the patient breathes will be recorded for 3-5 min. The total period of testing per session should take approximately 15 minutes per person, including the movement of the device and the positioning of the patient.
Physiological and clinical data collection at each study point:
Dates of onset of breathing difficulty, admission and discharge Oxygen treatment and breathing support (Flow in L/min for HFNC, Fi02 %O2, CPAP settings) Current medication Need for NG-tube Need for IV-fluids Heart Rate SaO2 Respiratory Rate
Data analysis will include the traditional time indices from tidal breathing, and the variability of these time indices.
Appropriate statistical analyses will be identified depending on the study and distribution of the samples (parametric vs. non-parametric). It is suspected that t-tests (one-sample to two sample), analysis of variance (ANOVA), or Mann-Whitney-U tests will be used where appropriate.
The investigators will also explore novel higher levels of data interpretation including Bayesian interpretation of respiratory function, and machine learning to predict disease diagnosis, severity and discharge.
Children admitted to paediatric HDU/ICU wards for acute obstructive airways disease aged 1 month to 12 years
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Non-invasive non-contact measurement of tidal breathing during hospital admission
Clinical severity of breathing distress measured by modified pulmonary index score (mPIS)
To examine whether SLP can predict clinical severity, the relationship between SLP tidal breathing parameters and clinical score (mPIS is a composite score from RR, HR, Sat02, Wheezing, Accessory muscle use, Inhalation-Exhalation-ratio) will be assessed. For each of these 6 measurements or observations, a score of 0 to 3 is assigned, resulting in a possible minimum score of 0 and a maximum score of 18. A cut-off score of 12 has been studied to distinguish more severe asthmatic exacerbation in children. (Carrol et al 2005) Primary outcome measure: mPIS
Time frame: Change in clinical severity score during hospital admission. Data will be collected for each child once in 24 hour periods for 2-10 times during hospital stay.
Regional SLP tidal breathing parameters (relative contribution)
To characterise regional thoraco-abdominal movements in children with obstructive airways disease and to examine the effect of standard treatment procedures on this movement. Primary Outcome measure: Regional SLP tidal breathing parameter (relative contribution)
Time frame: Change in SLP relative contribution during hospital admission. Data will be collected for each child once in 24 hour periods for 2-10 times during hospital stay.
Regional SLP tidal breathing parameters (phase)
To characterise regional thoraco-abdominal movements in children with obstructive airways disease and to examine the effect of standard treatment procedures on this movement. Primary Outcome measure: Regional SLP tidal breathing parameter (phase).
Time frame: Change in SLP phase during hospital admission. Data will be collected for each child once in 24 hour periods for 2-10 times during hospital stay.
Clinical outcome (Length of stay)
To examine whether tidal breathing patterns can predict clinical outcome, the relationship between SLP tidal breathing parameters and clinical outcome (as measured by length of hospital stay \[LOS\]) will be assessed. Primary outcome measures: LOS
Time frame: Length of stay is calculated as time from hospital admission (entering the primary ward) to time of hospital discharge (leaving the final ward). The estimated length of hospital stay will be a minimum of 1 and maximum of 30 days.
Plan to share: No
Ran from Jun 2018 to primary completion in Dec 2018, 6 months.
Of 364 non-industry observational studies under Asthma, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 97. This study's 6 months is below that.
Counting every sponsor, half of 454 studies reached it within 36 months; a quarter within 18 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Guy's and St Thomas' NHS Foundation Trust →