Asthma AcuteRAPAENCT06360185
Retrospective Study of Patients with Acute Presentation for Asthma to an Emergency Department in UK (RAPAE)
An observational study of Asthma Acute, run by Norfolk and Norwich University Hospitals NHS Foundation Trust.
Trial summary
Study team will obtain a list of all patients who have been seen in A+E over the past 6 years with a discharge diagnosis of asthma. Their history will be reviewed from their A+E notes. Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- Asthma Acute
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to 1 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The gender split changes with age: at age 11 years the relative risk of boys compared to girls within asthma population is 1.1 and by age 16 years the relative risk is 0.669. This change in gender association for asthma is poorly understood but highlights the complexities of asthma epidemiology. Adult asthma patients are more likely to be female and the study team would like to investigate if hormonal factors are related to reasons for presentation. This is difficult to elucidate in a retrospective study so the team is hoping that this study will inform them so they can undertake a prospective funded study regarding this service.
Who may be able to join
- All Asthmatics patients who attend Emergency department over 5 years
Who cannot join
- None Asthmatics.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ashnish Sinha contact
About this study
Official title: Retrospective Study Investigating the Clinical Characteristic of Patients with Acute Presentation for Asthma to the A+E Department in a Busy Acute Hospital in England UK in Era of Biological Therapy for Asthma Between Jan 2019 & Jan 2024
Study team will obtain a list of all patients who have been seen in A+E over the past 6 years with a discharge diagnosis of asthma. Their history will be reviewed from their A+E notes. Team will obtain weight and height from Electronic prescribing tool and will obtain compliance information and past medical history from participant's GP records. Team will use participant's postcode to word out socio economic status quintile using office of national statistics tool. The following information will be taken from hospital documentation and from GP records.
Read the detailed description
- How many previous admissions in past one year (12 months)
- How many presentations to A+E in previous one year (12 months)
- Diagnosis not confirmed therefore not on any ICS
- Poor compliance (less than 75% of ICS and/or LABA and/or LAMA and/or leukotriene prescriptions picked up in past year)
- Recent presentation and maintenance therapy not increased (primary care or secondary care issue)
- Is patient overweight BMI
- Is patient on hormonal therapy, OCP, HRT, male hormones
- Social class quintile from post code of address using ONS calculator
- Ethnically diverse (see appendix)
- First Eosinophil count on index admission
- Highest eosinophil count in past (ever) and date
- Treatment for diabetes type 2
- Treatment for diabetes type 1
- Treatment for hypertension
- Smoker ever (pack year) when gave up__________
After obtaining this information study team will use simple statistical methods such as frequency and associations with confidence intervals to investigate which factors are associated with frequency of presentation to A+E. They will ascertain the frequency of patients who are on maximum therapy and may benefit from biological therapy, especially if they have raised eosinophils in the past year.
- Conditions
- Asthma Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthmatics presenting to the emergency department in NNUH over 5 years | Asthmatics presenting to the emergency department in NNUH over 5 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Information will be taken from hospital documentation and from GP records.
Measured: 5 years
Change in body height
Information will be taken from hospital documentation and from GP records.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2024
- Study startDec 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sadiyah Hand, FRPC, Principal investigator, Consultant Respiratory Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06360185
- Sponsor's protocol ID
- Asthma V2 October 2023
- Acronym
- RAPAE
- Status last verified
- Mar 2024
- First submitted
- 15 Dec 2023
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study Investigating the Clinical Characteristic of Patients with Acute Presentation for Asthma to the A+E Department in a Busy Acute Hospital in England UK in Era of Biological Therapy for Asthma Between Jan 2019 & Jan 2024
- ClinicalTrials.gov ID
- NCT06360185
- Acronym / sponsor ID
- RAPAE / Asthma V2 October 2023
- Conditions
- Asthma Acute
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 11 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study team will obtain a list of all patients who have been seen in A+E over the past 6 years with a discharge diagnosis of asthma. Their history will be reviewed from their A+E notes. Team will obtain weight and height from Electronic prescribing tool and will obtain compliance information and past medical history from participant's GP records. Team will use participant's postcode to word out socio economic status quintile using office of national statistics tool. The following information will be taken from hospital documentation and from GP records.
Detailed description
- How many previous admissions in past one year (12 months)
- How many presentations to A+E in previous one year (12 months)
- Diagnosis not confirmed therefore not on any ICS
- Poor compliance (less than 75% of ICS and/or LABA and/or LAMA and/or leukotriene prescriptions picked up in past year)
- Recent presentation and maintenance therapy not increased (primary care or secondary care issue)
- Is patient overweight BMI
- Is patient on hormonal therapy, OCP, HRT, male hormones
- Social class quintile from post code of address using ONS calculator
- Ethnically diverse (see appendix)
- First Eosinophil count on index admission
- Highest eosinophil count in past (ever) and date
- Treatment for diabetes type 2
- Treatment for diabetes type 1
- Treatment for hypertension
- Smoker ever (pack year) when gave up__________
After obtaining this information study team will use simple statistical methods such as frequency and associations with confidence intervals to investigate which factors are associated with frequency of presentation to A+E. They will ascertain the frequency of patients who are on maximum therapy and may benefit from biological therapy, especially if they have raised eosinophils in the past year.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthmatics presenting to the emergency department in NNUH over 5 years | – | –Asthmatics presenting to the emergency department in NNUH over 5 years |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The gender split changes with age: at age 11 years the relative risk of boys compared to girls within asthma population is 1.1 and by age 16 years the relative risk is 0.669. This change in gender association for asthma is poorly understood but highlights the complexities of asthma epidemiology. Adult asthma patients are more likely to be female and the study team would like to investigate if hormonal factors are related to reasons for presentation. This is difficult to elucidate in a retrospective study so the team is hoping that this study will inform them so they can undertake a prospective funded study regarding this service.
Key inclusion criteria (1 listed)
- All Asthmatics patients who attend Emergency department over 5 years
Key exclusion criteria (1 listed)
- None Asthmatics.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in body weight
Time frame: 5 years
Information will be taken from hospital documentation and from GP records.
Change in body height
Time frame: 5 years
Information will be taken from hospital documentation and from GP records.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashnish Sinha contact
Sadiyah Hand, FRPC principal investigator
Consultant Respiratory Physician
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma Acute, run by Norfolk and Norwich University Hospitals NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sadiyah Hand, FRPC (01603 289612 ext. 5612, sadiyah.hand@nnuh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.