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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06008145
Other study ID # 23RM005
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 21, 2023
Est. completion date October 31, 2024

Study information

Verified date September 2023
Source Nottingham University Hospitals NHS Trust
Contact Joanne Porte, MSc
Phone 0115 8231723
Email Joanne.Porte@nottingham.ac.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The Targeted Lung Health Check (TLHC) is currently being rolled out in many regions of the United Kingdom and has just started in Nottingham. The same cohort of people are also at high risk for Chronic Obstructive Pulmonary Disease (COPD), a lung condition often caused by smoking and leading to breathlessness and cough. This study aims to provide pilot evidence of the role of breathing tests in those who have had a Computerised Tomography (CT) scan, in order to early diagnose COPD. Currently, at diagnosis, many patients have lost 30-40% of lung function already, which is not reversible. This study will use the Nottingham University Hospitals Trust Mobile Research Unit. The unit will follow the CT scanner route 2-3 weeks later, and people who have had a CT scan will be invited for breathing tests. Participants will also collect further information on potential treatment options for people diagnosed with COPD earlier -including smoking cessation, symptom management and general health advice (vaccinations, diet, activity and managing infections). There is also an optional blood test. The study aims are to determine the uptake and acceptability of breathing tests in patients at high risk of COPD, and if a community based approach co-locating with TLHC can increase uptake.


Description:

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Study Design


Related Conditions & MeSH terms

  • COPD
  • Pulmonary Disease, Chronic Obstructive

Locations

Country Name City State
United Kingdom Nottingham University Hospitals NHS Trust Nottingham Nottinghamshire

Sponsors (2)

Lead Sponsor Collaborator
Nottingham University Hospitals NHS Trust University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of people who take up the invite to attend for a C-FIND visit. 0-100% 1.5 years
Secondary Proportion diagnosed with COPD 0-100% 1.5 years
Secondary CAT COPD Quality of Life Score Questionnaire. Wellbeing and daily life questions, scored 0-40 points, lower better 1 day
Secondary MRC breathlessness score Questionnaire, self reported breathlessness grade 1-5, lower better 1 day
Secondary Exacerbation Frequency 0-12/year 1 day
Secondary EQ-5D-5L - Health Status Questionnaire. Self reported health scale 0-100. Greater better 1 day
Secondary Oximetry for oxygen saturations 75-100% Oxygen saturation 1 day
Secondary Height Participant height in metres - range 1.2-2.0m 1 day
Secondary Weight participant weight in Kg - range 35-180Kg 1 day
Secondary BMI 12-60g/m2 1 day
Secondary Blood pressure diastolic 40-120mmHg 1 day
Secondary Post bronchodilator Spirometry Forced Expired Volume (FEV)% - range 10-140% predicted 1 day
Secondary FOT-R (Resistance) cmH2O.s/l 1 day
Secondary FOT-X (reactance) cmH2O.s/l 1 day
Secondary FOT-AX (area of reactance) cmH2O/L 1 day
Secondary FOT-Fres (resonant Frequency) Hz 1 day
Secondary Blood pressure -systolic 75-230mmHg 1 day
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