Does ensuring people go home from hospital on the right inhalers after an exacerbation of chronic obstructive pulmonary disease reduce the risk of being re-admitted to hospital?
| ISRCTN | ISRCTN16732324 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16732324 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 309854 |
| Protocol serial number | IRAS 309854, CPMS 52972 |
| Sponsor | Royal Free London NHS Foundation Trust |
| Funder | National Institute for Health and Care Research |
- Submission date
- 01/09/2022
- Registration date
- 08/09/2022
- Last edited
- 19/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Chronic obstructive pulmonary disease (COPD) is the name for a group of lung conditions that cause breathing difficulties. This study tests if optimising the inhaled medicines of people living with COPD who have been admitted to hospital with a chest infection called an 'exacerbation', helps reduce the risk of death and readmission to hospital over the following 3 months. This is a preliminary study called a 'feasibility study' that will tell us if a full-size study to answer the question is possible.
Who can participate?
Patients aged 18 years and over who have been admitted to hospital with an exacerbation of COPD
What does the study involve?
Participants' clinicians will use a new tool to see if they are on the right inhalers. If not, they will suggest making a switch. Participants will then be phoned at 30 and 90 days to see how they got on with the new inhalers(s) if inhalers were switched, and to see if they were re-admitted to hospital. Some participants and some clinicians too will undergo more in-depth interviews about inhaler switching in this way.
What are the possible benefits and risks of participating?
The benefit to taking part is that there will be a closer look at the inhalers people are using. If there is a switch, the new inhaler(s) may not suit the person so well.
Where is the study run from?
The study is being run from the Royal Free Hospital in London, with people also invited to take part in Birmingham and Newcastle (all in the UK).
When is the study starting and how long is it expected to run for?
February 2022 to July 2023
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Ms Anne-Marie Preston, anne-marie.preston@nhs.net
Contact information
Principal investigator
UCL Respiratory
University College London
London
NW3 2QG
United Kingdom
| 0000-0002-7246-6040 | |
| Phone | +44 (0)2077940500 |
| j.hurst@ucl.ac.uk |
Scientific
UCL Respiratory
University College London
London
NW3 2QG
United Kingdom
| Phone | +44 (0)20 7794 0500 |
|---|---|
| j.hurst@ucl.ac.uk |
Public
Royal Free London NHS Foundation Trust
London
NW3 2PF
United Kingdom
| Phone | +44 (0)20 7794 0500 |
|---|---|
| anne-marie.preston@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Feasibility study |
| Secondary study design | Longitudinal study |
| Study type | Participant information sheet |
| Scientific title | Optimised inhalers to reduce chronic obstructive pulmonary disease exacerbation re-admissions and mortality: a feasibility study |
| Study acronym | OPTIHALE |
| Study objectives | This study will test the hypothesis that re-admissions and mortality after a hospitalised chronic obstructive pulmonary disease (COPD) exacerbation can be reduced by optimising both inhaled drug prescription and device prior to discharge. This is a feasibility study. |
| Ethics approval(s) | Approved 01/07/2022, Black Country Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham HRA1 Meeting Room, NG1 6FS, UK; +44 (0)207 104 8010; blackcountry.rec@hra.nhs.uk), ref: 22/WM/0125 |
| Health condition(s) or problem(s) studied | Exacerbations of chronic obstructive pulmonary disease (COPD) |
| Intervention | Participants' clinicians will use a new tool to see if they are on the right inhalers. If not, they will suggest making a switch. Participants will then be phoned at 30 and 90 days to see how they got on with the new inhalers(s) if inhalers were switched, and to see if they were re-admitted to hospital. Some participants and some clinicians too will undergo more in-depth interviews about inhaler switching in this way. |
| Intervention type | Other |
| Primary outcome measure(s) |
The primary aim of this study is to establish the feasibility of a future definitive trial; as such the feasibility outcomes are to measure: |
| Key secondary outcome measure(s) |
In addition, to inform the power calculation for a definitive study, the researchers will assess: |
| Completion date | 31/07/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 300 |
| Key inclusion criteria | 1. In hospital with an exacerbation of COPD 2. Age 18 years or over 3. Able to provide informed consent |
| Key exclusion criteria | Discharge home with palliative care |
| Date of first enrolment | 03/10/2022 |
| Date of final enrolment | 30/04/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
London
NW3 2QG
United Kingdom
Birmingham
B15 2GW
United Kingdom
Newcastle upon Tyne
TS1 4LP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 04/03/2024 | 19/07/2024 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/07/2024: Publication reference added.
03/10/2022: Internal review.
02/09/2022: Trial's existence confirmed by the NIHR.