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Airway Intervention Registry (AIR): Recurrent Respiratory Papillomatosis (RRP) (AIR:RRP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03465280
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : January 11, 2022
Sponsor:
Collaborators:
Alder Hey Children's NHS Foundation Trust
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust

Brief Summary:

Recurrent Respiratory Papillomatosis (RRP) causes wart-like growths in the airway which can make it difficult to breathe, speak and carry out normal everyday activities. It is a rare condition affecting all ages, 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. Aim: To identify which RRP treatments currently used in National Health Service (NHS) hospitals within the United Kingdom (UK) are the most effective and safest in the short- and long-term. It will also identify which patients respond best to specific treatments, and those who are at higher risk of experiencing a complication after treatment.

Method: Collect information from usual patient care and quality of life questionnaire responses in a secure online database. Participation in this study requires patient/parent/guardian consent. This observational study does not require patients to undergo any additional intervention as part of the research.


Condition or disease Intervention/treatment
Recurrent Respiratory Papillomatosis Human Papilloma Virus Procedure: Microdebrider Procedure: Cold-steel surgery (forceps) Procedure: Carbon dioxide laser Procedure: Potassium titanyl phosphate (KTP) laser Procedure: Pulsed dye laser Procedure: Radiofrequency ablation Procedure: Monopolar suction diathermy Procedure: Plasma coagulation Procedure: Other Other: Adjuvant therapies

Detailed Description:

Primary aim:

The overall goal is to improve the care of patients with Recurrent Respiratory Papillomatosis (RRP) - and the investigators aim to do this by determining the most effective and safe RRP treatments currently being used in patients in National Health Service (NHS) hospitals within the United Kingdom (UK) (information which is currently lacking).

By determining the most effective treatments of RRP, the investigators 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 the investigators will be able to determine the relative safety of treatments and identify those which slow the progression of disease.

From the data collected the investigators intend 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 treatments, and also identify patient risk factors which contribute to the complication outcomes (such as tracheostomy).

Secondary aims:

  • build an evidence base of the different RRP treatments used across the UK which will help to formulate hypotheses for future research in RRP and improve quality of life for RRP patients;
  • inform National Institute for Health and Care Excellence (NICE) interventional procedure guidance on radiofrequency cold ablation (IPG434,2012), which is currently under special arrangements due to lack of safety and efficacy evidence;
  • identify common symptoms or signs associated with RRP disease profile, to aid future diagnosis of RRP;
  • determine the geographical spread of RRP patients across the UK, to inform effective use of future NHS resources and inform the Department of Health strategy in its quadrivalent HPV vaccination programme (protecting against four types of HPV including types 6 and 11 commonly associated with RRP) currently offered to 12-13 year old girls within the NHS childhood vaccination programme;
  • inform future development of national clinical guidance on management of RRP to ensure that everyone receives the best care based on best available current knowledge;
  • determine impact of COVID on RRP patients including changes to RRP management, RRP symptoms.

Objectives:

The investigators will make use of an existing secure online database platform (the Airway Intervention Registry, AIR - developed and hosted by The Newcastle upon Tyne Hospitals NHS Foundation Trust, NUTH) and its associated infrastructure and develop it to capture additional observational outcomes from standard clinical practice and quality of life questionnaires from RRP patients. All RRP patients (any age) receiving treatment in any UK NHS hospital will be eligible for inclusion. Data collection will be open for 53 months with no minimum follow-up required for patients. Due to its recurrent nature (requiring regular hospital visits to maintain an open airway), following this patient population will allow the investigators to determine both the short- and long-term relative safety and efficacy of RRP treatments used in the UK. Consent will be required (from patients/parent/guardian) before data are entered into the online database.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 53 Months
Official Title: Airway Intervention Registry (AIR) Extension: Recurrent Respiratory Papillomatosis
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Microdebrider
    Removal of lesions via microdebrider
  • Procedure: Cold-steel surgery (forceps)
    Removal of lesions via forceps
  • Procedure: Carbon dioxide laser
    Removal of lesions via carbon dioxide laser
  • Procedure: Potassium titanyl phosphate (KTP) laser
    Removal of lesions via KTP laser
  • Procedure: Pulsed dye laser
    Removal of lesions via pulsed dye laser
  • Procedure: Radiofrequency ablation
    Removal of lesions via radiofrequency ablation
  • Procedure: Monopolar suction diathermy
    Removal of lesions via monopolar suction diathermy
  • Procedure: Plasma coagulation
    Removal of lesions via plasma coagulation
  • Procedure: Other
    Removal of lesions via other methods
  • Other: Adjuvant therapies
    All adjuvant therapies
    Other Names:
    • Acyclovir
    • Artemisinin
    • Bevacizumab (Avastin)
    • Celecoxib (Celebrex)
    • Cidofovir
    • Cimetidine
    • Di-indolmethane (DIM)
    • Gardasil
    • Indole-3-carbinol (I3C)
    • alpha-Interferon
    • PEG-Interferon
    • Methotrexate
    • Retinoic acid (isotretinoin)
    • Ribavarin
    • Other


Primary Outcome Measures :
  1. Time interval between surgical interventions [ Time Frame: Over study duration (53 months) ]
    Time between surgical interventions to maintain symptomatic control


Secondary Outcome Measures :
  1. RRP surgical intervention - nature [ Time Frame: Over study duration (53 months) ]
    Nature of intervention

  2. RRP surgical intervention - timing [ Time Frame: Over study duration (53 months) ]
    Timing of intervention

  3. RRP adjuvant therapy - nature [ Time Frame: Over study duration (53 months) ]
    Nature of intervention

  4. RRP adjuvant therapy - timing [ Time Frame: Over study duration (53 months) ]
    Timing of intervention

  5. Histology results [ Time Frame: Over study duration (53 months) ]
    Including HPV type

  6. Severity of papillomas [ Time Frame: Over study duration (53 months) ]
    Measured via Derkay severity score (higher score corresponding with higher severity; clinical score range 0-11, anatomical score range 0-75, summed total score range 0-86)

  7. Number of hospital visits/attendances [ Time Frame: Over study duration (53 months) ]
    Inpatient, Accident & emergency, Outpatient

  8. Voice assessment (paediatric) [ Time Frame: Over study duration (53 months) ]
    Measured via paediatric voice handicap index (higher score corresponding with higher voice handicap, range 0-99)

  9. Voice assessment (adult) [ Time Frame: Over study duration (53 months) ]
    Measured via voice handicap index (higher score corresponding with higher voice handicap, range 0-120)

  10. Short-term complications [ Time Frame: During hospital admission for RRP intervention (length of hospital stay can vary between patients e.g. from 0-100 days) ]
    Complications arising in-hospital

  11. Post-operative discharge location - planned [ Time Frame: During hospital admission for RRP intervention (length of hospital stay can vary between patients e.g. from 0-100 days) ]
    Planned discharge location (decided pre-operation)

  12. Post-operative discharge location - actual [ Time Frame: During hospital admission for RRP intervention (length of hospital stay can vary between patients e.g. from 0-100 days) ]
    Actual discharge location (occurring post-operation)

  13. Long-term complications [ Time Frame: Over study duration (53 months) ]
    Unexpected hospital, Accident & emergency (A&E), General Practitioner (GP) attendances due to RRP symptoms.

  14. Impact of COVID [ Time Frame: From March 2020 onwards (30 months) ]
    Test results, antibody results, symptoms, changes to management,



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with respiratory papillomatosis receiving hospital treatment
Criteria

Inclusion Criteria:

  • patients of any age (no restrictions) diagnosed with (newly diagnosed or existing) and receiving treatment for respiratory papillomatosis
  • informed assent/consent of data participation provided by patient/parent/guardian

Exclusion Criteria:

  • patients participating in other studies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465280


Contacts
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Contact: Andrew Sims 0191 244 8738 nuth.NMPCE.Air@nhs.net

Locations
Show Show 48 study locations
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Alder Hey Children's NHS Foundation Trust
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Adam Donne Alder Hey Children's NHS Foundation Trust
Additional Information:

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Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03465280    
Other Study ID Numbers: 08733
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Patients will be informed that all data collected will be used for research purposes, no patient identifiable information will be shared with external parties for commercial purposes, patient identifiable information will only be accessible by clinicians at their treating organisation, pseudonymised data will be accessed by study analysts, and that only anonymised high-level aggregate data will be shared with other centres to update participating centres of study progress and data completeness issues. Patients will also be informed that any external researchers requesting data from the registry will be required to submit a formal application form and evidence of appropriate ethical approvals in place for review by the Steering Group. If approval is given, only anonymised data will be shared for the purposes of external research studies.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:
Recurrent respiratory papillomatosis
Additional relevant MeSH terms:
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Respiratory Tract Infections
Papillomavirus Infections
Papilloma
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Infections
Respiratory Tract Diseases
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Interferons
Acyclovir
Cidofovir
Interferon-alpha
Artemisinins
Artemisinin
Celecoxib
Bevacizumab
Methotrexate
Indole-3-carbinol
Isotretinoin
Cimetidine
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs