Airway Intervention Registry (AIR) extension: Recurrent Respiratory Papillomatosis
| ISRCTN | ISRCTN36100560 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36100560 |
| ClinicalTrials.gov (NCT) | NCT03465280 |
| Protocol serial number | 38013 |
| Sponsor | The Newcastle upon Tyne Hospitals NHS Foundation Trust |
| Funder | NIHR Central Commissioning Facility (CCF); Grant Codes: PB-PG-0416-20037 |
- Submission date
- 08/05/2018
- Registration date
- 12/06/2018
- Last edited
- 25/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Recurrent Respiratory Papillomatosis (RRP) causes wart-like growths in the airway which make it difficult to breathe, speak and carry out normal everyday activities. It is a rare condition but is more common and aggressive in children than in adults, affecting 4 in every 100,000 children. There is no known cure for RRP, but symptoms are checked through regular hospital visits, with multiple treatments or procedures under general anaesthetic needed to remove or shrink the growths which can grow back quickly. The problem is that nobody knows which treatments or procedures work best. The aim of this study is to collect information on airway procedures currently being used in UK NHS hospitals to determine which of the treatments are the safest and most effective.
Who can participate?
All patients (adults and children) with RRP receiving at least one treatment in a UK NHS hospital
What does the study involve?
Data is collected on all treatments for RRP in a secure, online database over a 28-month period from 01/04/2018 to 31/08/2020. By determining the most effective treatments for RRP, the aim is to increase the time interval between surgical treatments needed to control symptoms, and reduce the overall number of treatments, the severity and spread of papillomas in the airway, hospital visits, and medications, and ultimately improve quality of life in those with RRP. The safety of the different treatments are assessed to identify those which minimise the spread of disease. From the data collected, patient subgroups are identified who respond better to specific treatments, along with risk factors which contribute to complications (such as tracheostomy).
What are the possible benefits and risks of participating?
The main benefit of participation is the opportunity to address the current lack of evidence around the relative safety and efficacy of the various treatments used to manage RRP, which will improve outcomes for all RRP patients. As this is an observational study, there are no risks of participation, as the clinical treatment a patient receives will be exactly the same regardless of whether they consent to their data being entered to the registry or not.
Where is the study run from?
1. Alder Hey Children’s NHS Foundation Trust (UK)
2. Basildon & Thurrock University Hospitals NHS Foundation Trust (UK)
3. Blackpool Teaching Hospitals NHS Foundation Trust (UK)
4. Great Ormond Street Hospital for Children NHS Foundation Trust (UK)
5. North Cumbria University Hospitals NHS Trust (UK)
6. Nottingham University Hospitals NHS Trust (UK)
7. The Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
8. NHS Greater Glasgow and Clyde (UK)
added 19/11/2019:
9. Abertawe Bro Morgannwg University Health Board (UK)
10. Aintree University Hospital NHS Foundation Trust (UK)
11. Barts Health NHS Trust (UK)
12. Belfast Health and Social Care Trust (UK)
13. Betsi Cadwaladr University Health Board (UK)
14. Birmingham Children's Hospital NHS Foundation Trust (UK)
15. Bradford Teaching Hospitals NHS FT (UK)
16. Cambridge University Hospitals NHS Foundation Trust (UK)
17. Cardiff & Vale University Health Board (UK)
18. City of Sunderland Hospitals NHS Foundation Trust (UK)
19. County Durham and Darlington NHS Foundation Trust (UK)
20. Doncaster And Bassetlaw Hospitals NHS Foundation Trust (UK)
21. East Sussex Healthcare NHS Trust (UK)
22. Frimley Park Hospital NHS Foundation Trust (UK)
23. Hywel Dda Health Board (UK)
24. Imperial College (UK)
25. Isle of Wight NHS Trust (UK)
26. Leeds Teaching Hospitals NHS Trust (UK)
27. Lewisham and Greenwich NHS Trust (UK)
28. London North West Healthcare NHS Trust (UK)
29. Manchester University Hospitals NHS Foundation Trust (UK)
30. NHS Grampian (UK)
31. NHS Lothian (UK)
32. NHS Tayside (UK)
33. Oxford University Hospitals NHS FT (UK)
34. Pennine Acute Hospitals NHS Trust (UK)
35. Salford Royal NHS Foundation Trust (UK)
36. Sheffield Children's NHS Foundation Trust (UK)
37. South Tees Hospitals NHS Foundation Trust (UK)
38. St George's Healthcare NHS Trust (UK)
39. Stockport NHS Foundation Trust (UK)
40. The Shrewsbury and Telford Hospital NHS Trust (UK)
41. University Hospital Birmingham NHS FT (UK)
42. University College London Hospitals NHS Foundation Trust (UK)
43. University Hospital Southampton NHS Foundation Trust (UK)
44. University Hospitals of Derby and Burton NHS Foundation Trust (UK)
45. University Hospitals Plymouth NHS Trust (UK)
46. Wirral University Teaching Hospital NHS FT (UK)
When is the study starting and how long is it expected to run for?
September 2017 to August 2022
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Mrs Kim Fairbairn (née Keltie)
nuth.NMPCE.Air@nhs.net
Contact information
Scientific
Freeman Hospital
Newcastle upon Tyne
NE7 7DN
United Kingdom
 ORCID ID |
0000-0001-5108-6279 |
|---|---|
| Phone | +44 (0)191 213 8636 |
| nuth.NMPCE.Air@nhs.net |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational; Design type: Cohort study |
| Secondary study design | Cohort study |
| Participant information sheet | ISRCTN36100560_PIS_15Feb2018_v1.5.docx |
| Scientific title | Airway Intervention Registry (AIR) extension: Recurrent Respiratory Papillomatosis |
| Study acronym | AIR: RRP |
| Study objectives | Recurrent Respiratory Papillomatosis (RRP) causes wart like growths in the airway which make it difficult to breathe, speak and carry out normal everyday activities. It is a rare condition but is more common and aggressive in children than in adults, affecting 4 in every 100,000 children. There is no known cure for RRP, but symptoms are checked through regular hospital visits, with multiple therapies or procedures under general anaesthetic needed to remove or shrink the growths which can grow back quickly. The problem is that nobody knows which therapies or procedures work best. The Airway Intervention Registry (AIR) platform was designed to capture information on airway procedures. It was set up originally to capture information from any patient aged 18 years or less undergoing routine treatment for airway stenosis using balloon dilatation, or treatment for recurrent respiratory papillomatosis (RRP) with radiofrequency cold ablation, in order to answer the research questions highlighted by NICE as absent from the current evidence base on each procedure (see guidance 1.3 in IPG425 and IPG434). Registry data will help to address this gap. AIR has been collecting data on balloon dilatation for airway stenosis since 01/04/2015 and we are due to report back to NICE by 30/06/2018 to inform the IPG425 guidance update. As part of a national survey (Donne et al., 2016) we gathered clinical advice that radiofrequency cold ablation is not commonly used to treat RRP, and what was needed was safety and efficacy data gathered for all treatments for this condition. As RRP is such a rare disease we have extended data collection to include both adults and paediatrics. We secured funding from the NIHR’s RfPB programme to support the development of the RRP registry in paediatrics, which will be hosted on the same AIR platform (both ENT procedures, same clinical staff entering data but different patient population). Funding was received on 1st September 2017 for a 3 year fixed period. |
| Ethics approval(s) | Newcastle and North Tyneside 1, 29/12/2014, IRAS ID: 164160, REC ref: 14/NE/1200 |
| Health condition(s) or problem(s) studied | Recurrent Respiratory Papillomatosis |
| Intervention | The trialists are collecting observational data on all interventions for RRP in a secure, online database over a 28-month period from 01/04/2018 to 31/08/2020. The objective is to improve the care of patients with RRP by analysing the registry data to determine which of the RRP interventions currently being used in UK NHS hospitals are the safest and most effective (information which is currently lacking). By determining the most effective interventions for RRP, the trialists will be able to increase the time interval between surgical interventions to maintain symptomatic control, reduce overall number of RRP interventions, severity and spread of papillomas in the airway, hospital visits, medications and ultimately improve quality of life in those suffering from RRP. By also capturing peri- and post-procedural details they will be able to determine the relative safety of the different interventions available and identify those which minimise the spread of disease. From the data collected they will also be able to identify patient subgroups (based on patient characteristics such as age, gender, human papillomavirus (HPV) type, location of papillomas, RRP severity and spread, comorbidities) who respond better to specific interventions, and also identify patient risk factors which contribute to the complication outcomes (such as tracheostomy). |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Effectiveness of the interventions, assessed using the Derkay staging system to quantify RRP severity based on involvement of laryngeal structures. As this is observational data, the study will not require the patients to attend additional hospital appointments. They will be assessed at their routine hospital visits which will be scheduled according to clinical need over the course of the 28-month data collection period. |
| Key secondary outcome measure(s) |
1. Peri-procedural complications; Timepoint(s): At hospital discharge |
| Completion date | 31/08/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 400 |
| Key inclusion criteria | All patients (adults and paediatrics) with a diagnosis of RRP receiving at least one intervention for RRP in a UK NHS hospital |
| Key exclusion criteria | Patient/parent/guardian unable/unwilling to provide written informed assent/consent |
| Date of first enrolment | 01/04/2018 |
| Date of final enrolment | 31/08/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
- Northern Ireland
- Scotland
- Wales
Study participating centres
L14 5AB
United Kingdom
SS16 5NL
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FY3 8NR
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WC1N 3JH
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CA2 7HY
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NG5 1PB
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NE7 7DN
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G12 0XH
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L9 7AL
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B46NH
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BD9 6RJ
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CB2 0QQ
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SR4 7TP
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DL3 6HX
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DE22 3NE
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SA31 3BB
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PO30 5TG
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LS9 7TF
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SE13 6LH
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HA1 3UJ
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M13 9WL
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AB25 2ZB
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EH1 3EG
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PL6 8DH
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M68 HD
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S10 2TH
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TS4 3BW
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CH49 5PE
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DD2 1GZ
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United Kingdom
United Kingdom
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Any external researchers requesting data from the registry will be required to submit a formal application form describing which datafields are required, the time period of interest, if updates are required (i.e. monthly/annually), what the information will be used for and how the results of any analysis will be shared with the public. Only formal applications with appropriate ethical approvals in place (reviewed by an independent Ethics Committee) will be reviewed by the established AIR Steering Group committee. If successful, a data sharing agreement between applying researcher and Steering Group committee will be signed. If approval is given, only anonymised data will be shared for the purposes of external research studies. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 24/10/2024 | 25/10/2024 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Our experience in developing and operating the Airway Intervention Registry for Recurrent Respiratory Papillomatosis (AIR-RRP): national data collection | 12/01/2023 | 19/07/2024 | Yes | No |
| Participant information sheet | version v1.5 | 15/02/2018 | 12/06/2018 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version V1.5 | 17/04/2018 | 12/06/2018 | No | No |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN36100560_PIS_15Feb2018_v1.5.docx
- Uploaded 12/06/2018
- ISRCTN36100560_PROTOCOL_17Apr2018_V1.5.docx
- Uploaded 12/06/2018
Editorial Notes
25/10/2024: Publication reference added.
19/07/2024: Publication reference added.
04/08/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/08/2021 to 31/08/2022.
2. The overall end date was changed from 31/08/2021 to 31/08/2022.
04/08/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/08/2020 to 31/08/2021.
2. The overall end date was changed from 31/08/2020 to 31/08/2021.
3. The intention to publish date was changed from 31/08/2021 to 31/08/2022.
4. The plain English summary was updated to reflect these changes.
12/06/2020: Contact email address updated.
19/11/2019: The following changes were made to the trial record:
1. The following trial participating centres were added: Abertawe Bro Morgannwg University Health Board, Barts Health NHS Trust, Belfast Health and Social Care Trust, Betsi Cadwaladr University Health Board , Cardiff & Vale University Health Board, Doncaster And Bassetlaw Hospitals NHS Foundation Trust, East Sussex Healthcare NHS Trust, Frimley Park Hospital NHS Foundation Trust, Imperial College , Oxford University Hospitals NHS FT, Pennine Acute Hospitals NHS Trust, St George's Healthcare NHS Trust, Stockport NHS Foundation Trust, The Shrewsbury and Telford Hospital NHS Trust, University Hospital Birmingham NHS FT, University College London Hospitals NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust.
2. The plain English summary was updated to reflect these changes.
23/05/2019: ClinicalTrials.gov number added.
22/03/2019: The condition was updated from "Specialty: Children, Primary sub-specialty: Respiratory and Cystic Fibrosis; UKCRC code/ Disease: Respiratory/ Other diseases of upper respiratory tract" to "Recurrent Respiratory Papillomatosis".
24/01/2019: The following changes have been made to the trial record:
1. Aintree University Hospital NHS Foundation Trust was added as a trial participating centre
2. Birmingham Children's Hospital NHS Foundation Trust was added as a trial participating centre
3. Bradford Teaching Hospitals NHS FT was added as a trial participating centre
4. Cambridge University Hospitals NHS Foundation Trust was added as a trial participating centre
5. City of Sunderland Hospitals NHS Foundation Trust was added as a trial participating centre
6. County Durham and Darlington NHS Foundation Trust was added as a trial participating centre
7. Derby Hospitals NHS Foundation Trust was added as a trial participating centre
8. Hywel Dda Health Board was added as a trial participating centre
9. Isle of Wight NHS Trust was added as a trial participating centre
10. Leeds Teaching Hospitals NHS Trust was added as a trial participating centre
11. Lewisham and Greenwich NHS Trust was added as a trial participating centre
12. London North West Healthcare NHS Trust was added as a trial participating centre
13. Manchester University Hospitals NHS Foundation Trust was added as a trial participating centre
14. NHS Grampian was added as a trial participating centre
15. NHS Lothian was added as a trial participating centre
16. NHS Tayside was added as a trial participating centre
17. Plymouth Hospitals NHS Trust was added as a trial participating centre
18. Salford Royal NHS Foundation Trust was added as a trial participating centre
19. Sheffield Children's NHS Foundation Trust was added as a trial participating centre
20. South Tees Hospitals NHS Foundation Trust was added as a trial participating centre
21. Wirral University Teaching Hospital NHS FT was added as a trial participating centre
12/06/2018: Uploaded protocol Version 1.5 17 April 2018 (not peer-reviewed).
