Clinic Versus Home Spirometry (COMPAIR)
Research type
Research Study
Full title
A Comparison of Clinic-based Versus Home-based Spirometry
IRAS ID
288594
Contact name
Tim Harrison
Contact email
Sponsor organisation
The University of Nottingham
Duration of Study in the UK
0 years, 4 months, 0 days
Research summary
Research Summary
Asthma and Chronic Obstructive Pulmonary Disease (COPD) are respiratory diseases of the airway. Both diseases are characterised by airflow limitation, measured using spirometry. Spirometry is therefore an essential tool in the diagnosis, assessment and monitoring of patients and is an outcome measure in many clinical trials.
Home spirometry, as opposed to spirometry conducted in the research centre, would potentially reduce the requirement for clinic visits, which can be time consuming and inconvenient for participants, increase the number of patients able to participate in research and increase the real-world nature of clinical trials.
However, to be considered valid, spirometry must be quality assured. It is dependent upon the effort given by the patient as it is a forced manoeuvre and poorly performed spirometry is misleading. To achieve quality assured spirometry, the patient has to be corrected instructed in technique and should have it demonstrated. Coaching and encouragement should be given during the procedure and should only be performed by staff who have been trained and assessed to a recognised standard.
This study aims to compare the quality of spirometry performed with the NuvoAir Air Next Spirometer, in the research clinic setting, under direct and virtual supervision from research staff and in the home setting, under virtual supervision. This will be achieved by comparing lung function values, specifically the FEV1 and FVC measurements.
We also wish to evaluate participant's views on the experience of home spirometry.
We are aiming to recruit 68 participants with Asthma and COPD across research centres in the UK (England) who will attend 4 visits, in the research and home setting over a period of approximately 8 days.
Summary of Results
What public involvement was there?
The study was conceptualised with the support of our local patient and public involvement group at the Nottingham asthma centre. They ensured that the design of the study would support those who took part. The group consists of those who have chronic respiratory conditions such as asthma or Chronic Obstructive Pulmonary Disease (COPD) or have previously been involved in designed research studies with us.Where and when the study took place.
The study took place across 3 sites:
• Nottingham City Hospital – Nottingham Biomedical Research Centre
• Rotherham General Hospital – Breathing Space
• Bradford Royal Infirmary- The Bradford Institute for Health Research.
Participants were recruited from outpatient clinics, research databases and also whilst being admitted during a hospital admission across the three sites.Why was the research needed
Those with chronic respiratory conditions such as asthma and COPD often take part in research to help us better understand these conditions. One way of measuring breathing is through doing lung function tests using a device called a spirometer. During the COVID-19 pandemic, many patients had to shield to protect themselves and some research had to stop. Supervised spirometry at home is a way in which pariticipants can test their lung function with a spirometer whilst being watched by a healthcare professional trained in using the device. This means that spirometry for research could potentially be done from the participants home. We wanted to assess the reliability of using the NuvoAir Air Next Spirometer® in a clinical setting and at home to see if the values obtained in both settings matched. We also wished to obtain participants perspective on the device and its usefulness.The objectives of the study were to:
Primary Objectives
1. To compare spirometric values obtained from the NuvoAir Air Next device, directly supervised in clinic and virtually supervised in clinic and at home.
2. To compare spirometric values obtained from two virtually supervised tests performed at home, using the NuvoAir Air Next device.
Secondary Objective
1. To evaluate the participant’s views of home spirometry via a survey.The Study schedule for COMPAIR:
Day 1 (Visit 1) in Clinic
One session of supervised face to face spirometry followed by a session of supervised virtual spirometry, with the research team member and participant in different rooms.
Day 2 (Visit 2) at Home
Supervised virtual spirometry, with the participant at home, communicating with the research team via videoconferencing.
Day 7 (Visit 3) at Home
Supervised virtual spirometry, with the participant at home, communication with the research team via videoconferencing.
Day 8 (Visit 4) in Clinic
One session of supervised face to face spirometry followed by a session of supervised virtual spirometry, with the research team member and participant in different rooms.
This visit also involved completing a survey to gauge participant views.Who participated in the study
We recruited those patients with a diagnosis asthma or COPD who were between the age of 18-80. To see what there normal lung function was like we did not include participants who had a flare up of their condition 4 weeks before entering the study. In total we 68 participants completed the study.What were the results of the study?
We recruited 47 participants with asthma and 21 participants with COPD.
We measured two measures of lung function:
• FEV1: the Forced Expiratory Volume in 1 second (FEV1) which is the amount of breath forcefully blown out in 1 second after filling their lungs up as much as they can with a deep breath in.
• FVC: the Force Vital Capacity (FVC). This is the total amount of air forcefully blown about after filling the lungs up with as much air with a deep breath in.
These two measurements are good measurements of how the lungs are functioning in asthmatic and OCPD patients. We found that these numbers were very close to each other when performed both in clinic and when at home for the 68 participants who completed the study.
From the survey we undertook, participants valued the use of home spirometry with the majority find the Nuvoair Air Next device easy to use with and could see the potential of home spirometry to monitor their condition.Has the study helped patients and researchers?
The study has shown that when spirometry is performed by patients with airway conditions such as asthma or COPD and when performed supervised at home; the results obtained were just as good as when it was performed in a clinical setting directly supervised.
Supervised spirometry performed at home is potentially a good option for the monitoring of chronic airway diseases such as COPD and Asthma.Where can I learn more about the study
The manuscript for the study is currently being written. Findings of the research will soon be published shortly on our website https://www.nrru.orgREC name
HSC REC A
REC reference
20/NI/0152
Date of REC Opinion
7 Jan 2021
REC opinion
Further Information Favourable Opinion