Airway Intervention Registry (AIR) extension: Recurrent Respiratory Papillomatosis
| ISRCTN | ISRCTN36100560 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36100560 |
| ClinicalTrials.gov number | NCT03465280 |
| Secondary identifying numbers | 38013 |
- 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
| Study design | Observational; Design type: Cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 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. 2. Quality of life, measured using the Voice Handicap Index (VHI) questionnaire (for patients aged 16 or over) or the paediatric Voice Handicap Index (pVHI) for patients under 16. Patients currently complete these questionnaires as part of their standard care at hospital appointments. Patients who have consented to taking part in the study will also be given a unique QoL ID so that they can submit additional QoL forms via a secure patient website at their convenience. |
| Secondary outcome measures | 1. Peri-procedural complications; Timepoint(s): At hospital discharge 2. Airway related A&E visits; Timepoint(s): After hospital discharge 3. Airway related GP visits; Timepoint(s): After hospital discharge 4. Change in Derkay score (disease severity and spread); Timepoint(s): Over 28-month data collection period 5. Change in voice assessment scores; Timepoint(s): Over 28-month data collection period 6. Inter-surgical interval (time between interventions to achieve symptomatic control); Timepoint(s): Over 28-month data collection period 7. Nature and timing of surgical intervention; Timepoint(s): Over 28-month data collection period 8. Nature and timing of adjuvant therapy; Timepoint(s): Over 28-month data collection period 9. Histology results (including HPV type); Timepoint(s): Over 28-month data collection period 10. No. of hospital visits/admissions (inpatient, outpatient); Timepoint(s): Over 28-month data collection period 11. Post-operative discharge location (planned and actual); Timepoint(s): After procedure (following RRP intervention) |
| Overall study start date | 01/09/2017 |
| Completion date | 31/08/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | Planned Sample Size: 400; UK Sample Size: 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
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
L14 5AB
United Kingdom
SS16 5NL
United Kingdom
FY3 8NR
United Kingdom
WC1N 3JH
United Kingdom
CA2 7HY
United Kingdom
NG5 1PB
United Kingdom
NE7 7DN
United Kingdom
G12 0XH
United Kingdom
L9 7AL
United Kingdom
B46NH
United Kingdom
BD9 6RJ
United Kingdom
CB2 0QQ
United Kingdom
SR4 7TP
United Kingdom
DL3 6HX
United Kingdom
DE22 3NE
United Kingdom
SA31 3BB
United Kingdom
PO30 5TG
United Kingdom
LS9 7TF
United Kingdom
SE13 6LH
United Kingdom
HA1 3UJ
United Kingdom
M13 9WL
United Kingdom
AB25 2ZB
United Kingdom
EH1 3EG
United Kingdom
PL6 8DH
United Kingdom
M68 HD
United Kingdom
S10 2TH
United Kingdom
TS4 3BW
United Kingdom
CH49 5PE
United Kingdom
DD2 1GZ
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
Sponsor information
Hospital/treatment centre
Freeman Hospital
Freeman Road
High Heaton
Newcastle-upon-Tyne
NE7 7DN
England
United Kingdom
"ROR" |
https://ror.org/05p40t847 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/08/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results will be available to clinicians via open-access peer-reviewed manuscripts (e.g. Clinical Otolaryngology) and presentations/posters at appropriate clinical conferences (with attendance at three conferences specifically included in the funding application: ENT UK 2018 annual conference to promote RRP database, ENT UK 2019 annual conference to share initial results and data completeness/quality issues, EPSO 2020 international conference to share results of 3 year study). This will enable results to reach clinicians in acute care, and national bodies (e.g. NICE) so that they can be used to update national guidance and inform commissioners. The trialists will also liaise with professional bodies (e.g. ENT UK, British Association for Paediatric Otolaryngology (BAPO)) to display the published report on their website and share with their members via emailed newsletters (both ENT UK and BAPO were engaged with the UK cross-sectional survey and contributed to publicising results using the methods already described). The trialists have included costs for three focus groups with their local YPAGne group during the study duration (one each year of the study). The local PPI group will guide writing and dissemination of lay summaries of our findings, which will be shared on patient forums, charity websites, social media and by any other appropriate means suggested. The trialists have also acted on feedback provided by their local YPAGne group to share recruitment rates and interim results on a dedicated study website to ensure that results reach patients and are presented in a format which is appropriate to young patients. |
| 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? |
|---|---|---|---|---|---|
| Participant information sheet | version v1.5 | 15/02/2018 | 12/06/2018 | No | Yes |
| Protocol file | version V1.5 | 17/04/2018 | 12/06/2018 | No | 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 |
| Results article | 24/10/2024 | 25/10/2024 | Yes | No |
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).
