Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000272493
Ethics application status
Approved
Date submitted
12/02/2025
Date registered
10/04/2025
Date last updated
20/04/2025
Date data sharing statement initially provided
10/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
IMmunological Precision therapy for Asthma and Chronic sinusiTis
Scientific title
The impact of Precision Medicine on Steroid and Antibiotic use in Participants with Asthma and Chronic Rhinosinusitis
Secondary ID [1] 313529 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
IMPACT Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Rhinosinusitis 335979 0
Nasal Polyps 335980 0
Asthma 335981 0
Condition category
Condition code
Respiratory 332570 332570 0 0
Asthma
Respiratory 332571 332571 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 333264 333264 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 330109 0
Diagnosis / Prognosis
Intervention code [2] 330611 0
Treatment: Other
Comparator / control treatment
100 Study Participants with Chronic Rhinosinusitis and Nasal Polyps who are to undergo sinus surgery will be randomised to Usual Care (UC) from their Ear Nose & Throat (ENT) Surgeon.

They will be followed up as per Standard of Care (SOC) with their ENT Surgeon. The number of appointments in the first 6 months post-operative is expected to be 3, but will be determined by their clinical presentation. At each appointment they will complete quality of life questionnaires and undergo nasal endoscopy.

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.
Control group
Active

Outcomes
Primary outcome [1] 340135 0
A change in cumulative Oral Corticosteroids (OCS) doses during the study.
Timepoint [1] 340135 0
Baseline, Month 6 and Month 12 post randomisation.
Primary outcome [2] 340844 0
A change in cumulative antimicrobial doses during the study.
Timepoint [2] 340844 0
Baseline, Month 6 and Month 12 post randomisation.
Secondary outcome [1] 442928 0
Change in Chronic Rhinosinusitis (CRS) control,
Timepoint [1] 442928 0
Baseline, Month 6 and Month 12 post randomisation.
Secondary outcome [2] 444878 0
Total number of CRS exacerbations.
Timepoint [2] 444878 0
Baseline, Month 6 and Month 12 post randomisation.
Secondary outcome [3] 444879 0
Need for further sinus surgery or treatment with monoclonal antibody therapy at Month 12.
Timepoint [3] 444879 0
Baseline, Month 6 and Month 12 post randomisation.
Secondary outcome [4] 445217 0
Change in asthma control.
Timepoint [4] 445217 0
First appointment with Respiratory Physician, Month 6 and Month 12 post randomisation.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A permuted randomisation will be used, with blocks of size 4 and 6, with 1:1 allocation ratio.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Analysis will be under the intention-to-treat principle using generalised linear models. The group difference in the primary outcome (transformed cumulative OCS and antibiotic doses) will be estimated by linear regression, adjusted for baseline (ANCOVA), with significance alpha equals 0.05. Therapy effect will be expressed as the baseline-adjusted mean group difference with 95% CI. Primary analyses will use all available data; sensitivity analyses such as multiple imputation will examine the robustness of conclusions to different assumed missing data mechanisms. The group difference in the secondary outcome of exacerbations, SNOT-22 and EQ5D will be estimated using negative binomial models, with a significance of alpha equals 0.05. Bayesian Model Averaging will be used to estimate the effects of individual traits and targeted interventions to the overall treatment of the multi-component package.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
31/05/2027
Actual
Date of last data collection
Anticipated
30/06/2028
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 27412 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 27413 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [3] 27414 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 43525 0
5000 - Adelaide
Recruitment postcode(s) [2] 43526 0
5011 - Woodville
Recruitment postcode(s) [3] 43527 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 317983 0
University
Name [1] 317983 0
The University of Adelaide
Country [1] 317983 0
Australia
Primary sponsor type
Government body
Name
Central Adelaide Local Health Network (CALHN) - Royal Adelaide Hospital
Address
Country
Australia
Secondary sponsor category [1] 320326 0
None
Name [1] 320326 0
Address [1] 320326 0
Country [1] 320326 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316653 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 316653 0
Ethics committee country [1] 316653 0
Australia
Date submitted for ethics approval [1] 316653 0
08/01/2025
Approval date [1] 316653 0
15/04/2025
Ethics approval number [1] 316653 0
CALHN Research Office Reference Number: 20875

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138546 0
Prof Harshita Pant
Address 138546 0
The Queen Elizabeth Hospital 28 Woodville Road, Woodville South, SA 5008
Country 138546 0
Australia
Phone 138546 0
+61 0405334707
Fax 138546 0
Email 138546 0
[email protected]
Contact person for public queries
Name 138547 0
Jenny Latte
Address 138547 0
Royal Adelaide Hospital, 8E311 Dept Thoracic Medicine, Port Road, Adelaide SA 5000
Country 138547 0
Australia
Phone 138547 0
+61 0481094969
Fax 138547 0
Email 138547 0
[email protected]
Contact person for scientific queries
Name 138548 0
Harshita Pant
Address 138548 0
lvl 6 AHMS Building, University of Adelaide, North Terrace, Adelaide, SA 5000
Country 138548 0
Australia
Phone 138548 0
+61 0405334707
Fax 138548 0
Email 138548 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.