None listed
Conditions
Brief summary
Asthma and other conditions can co-exist in patients with Chronic Rhinosinusitis with Nasal Polyps, which can adversely affect patient outcomes. It is uncertain if it is of benefit or cost effective for these patients to routinely see a Respiratory Physician. This study will answer this question. Patients who are planning to have Sinus Surgery treatment will be randomly allocated to two groups: One group will receive the Usual Care from their Ear Nose and Throat Surgeon. The other group will receive Precision Care, and will attend for an appointment with a Respiratory Physician and be assessed for asthma or other respiratory conditions and other medical conditions that they may have. These patients will then receive treatment for these conditions. It is proposed that patients receiving precision care will report greater improvement in their Chronic Sinusitis symptoms 12 months post surgery.
Interventions
200 Study Participants with Chronic Rhinosinusitis and Nasal Polyps who are to undergo sinus surgery will be randomised 1:1 to Precision Care (PC) of Treatable Traits or to Usual Care (UC) .
100 Study Participants randomised to PC. They will be referred to a Respiratory Physician who will assess them for a potential diagnosis of asthma, other respiratory conditions or other treatable traits such as Allergies, Aspirin Sensitivity, Autoimmune disorders, Smoking, Vocal Cord Disorders, Obstructi
200 Study Participants with Chronic Rhinosinusitis and Nasal Polyps who are to undergo sinus surgery will be randomised 1:1 to Precision Care (PC) of Treatable Traits or to Usual Care (UC) . 100 Study Participants randomised to PC. They will be referred to a Respiratory Physician who will assess them for a potential diagnosis of asthma, other respiratory conditions or other treatable traits such as Allergies, Aspirin Sensitivity, Autoimmune disorders, Smoking, Vocal Cord Disorders, Obstructive Sleep Apnoea, Obesity, Anxiety, Depression, Poor Medication Compliance. Appropriate referrals will then be made to other Specialised Health Professionals to treat and manage these. The initial appointment with the Respiratory Physician or any of the other Specialised Health Professionals will be approximately 40minutes long. It is unknown how many subsequent appointments will be required by the participants as it is dependent on their clinical presentation. If required will be of approximately 20minutes duration. Study participants may be required to attend for "testing' appointments e.g. Lung Function Testing, Sleep Study. These Study Participants will continue to have appointments with their Ear Nose & Throat (ENT) Surgeon as per Standard of Care (see description below). Study Participants will completely a weekly diary to report any exacerbations in Rhinosinusitis symptoms, any attendance with a health care professional, if a viral PCR was performed along with the result and if any new medications were commenced. Study Participants will be followed up for 1 year.
Sponsors
Central Adelaide Local Health Network (CALHN) - Royal Adelaide Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and Female Participants greater than and or equal to 18 years with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) based on European Position Paper on Rhinosinusitis and Nasal Polyps 2020 (EPOS 2020) criteria, who are planned for surgery: a. inflammation of the nose and the paranasal sinuses characterised by two or more symptoms, one of which should be either i. nasal blockage / obstruction / congestion ii. or nasal discharge (anterior / posterior nasal drip): plus or minus facial pain/pressure plus or minus reduction or loss of smell for a minimum of 12 weeks and either b. endoscopic signs of: i. nasal polyps, and/or ii. mucopurulent discharge primarily from middle meatus and/ or iii. oedema / mucosal obstruction primarily in middle meatus and/or c. CT changes: mucosal changes within the ostiomeatal complex and/or sinuses 2. At study entry, all Participants will be planned for sinus surgery. Participant who have previously undergone sinus surgery will be eligible for the study. 3. Must be able to communicate with site personnel and to understand and voluntarily sign the Informed Consent Form
Exclusion criteria
1. Have any other serious medical condition undergoing active treatment that may confound analysis. 2. Female Participants who are pregnant, lactating, or intend to become pregnant during the study period. Females who inadvertently become pregnant during the study will continue to be followed up as per protocol.
Outcome results
None listed