Allergic Fungal RhinosinusitisNCT06376071
Sinonasal Risk Factors for Occurrence of Unilateral Versus Bilateral Allergic Fungal Rhinosinusitis .
An observational study of Allergic Fungal Rhinosinusitis, run by Assiut University.
Trial summary
This study aims to assess Sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhino sinusitis regarding:: 1. anatomical variations and correlate radiological finding with intraoperative finding. 2. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Allergic Fungal Rhinosinusitis
- What is being tested?
- functional endoscopic sinus surgery
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients will be divided into two groups: Group (A): including patients with unilateral allergic fungal rhinosinusitis. Group (B): including patients with bilateral allergic fungal rhinosinusitis. Then all patient will subjected to EFSS under general anathesia with wide sinusotomics where intraoperative collection of data will be done as the follow
Who may be able to join
- Denovo cases . any Age Any sex. Patients diagnosed with unilateral or bilateral allergic fungal rhino sinusitis, meeting classic Bent and Kuhn criteria for AFRS:(10).
- Nasal polyposis. Fungi on staining. Eosinophilic mucin without fungal invasion into sinus tissue., Type I hypersensitivity to fungi. Characteristic radiologic findings with soft-tissue differential densities on computed tomographic (CT) scanning
Who cannot join
- Diagnosis of benign or malignant neoplasm of the sinonasal cavity. Prior radiation therapy to the head or neck. Significant prior facial trauma. Autoimmune disorder. Craniofacial anomaly. Fungus ball. Immunodeficiency. Cystic fibrosis. Patients unfit for surgery. Previous nasal surgery or recurrent cases .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Sinonasal Risk Factors for Occurrence of Unilateral Versus Bilateral Allergic Fungal Rhinosinusitis
This study aims to assess Sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhino sinusitis regarding::
- anatomical variations and correlate radiological finding with intraoperative finding.
- other associated factors like demographic ,environmental, immunological and climatic risk factors .
Read the detailed description
Introduction Allergic fungal rhinosinusitis (AFRS) is a subtype of CRS with nasal polyposis (CRSwNP) that is characterized by eosinophilic mucin within expanded sinus cavities and immunoglobulin E (IgE)-mediated type 1 hypersensitivity to fungal elements. This noninvasive disease process typically affects immunocompetent, younger patients in geographic regions with warm temperatures and high humidity, which facilitate fungal proliferation.
AFRS has a worldwide distribution pattern with varying prevalence. AFRS is presented in variable rates in different climatic, socioeconomic, and geographic factors. The disease prevalence showed predilection toward climatic factors
- Conditions
- Allergic Fungal Rhinosinusitis
- Being tested
- functional endoscopic sinus surgery
- Medical subject headings
- Allergic Fungal Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional endoscopic sinus surgeryDiagnostic test
functional endoscopic sinus surgery for diagnosis the disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhinosinusitis
analysis of the risk factors of unilateral versus bilateral allergic fungal rhinosinusitis
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Allergic Fungal RhinosinusitisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Al khater nosir sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06376071
- Sponsor's protocol ID
- fungal rhinosiusitis
- Status last verified
- Apr 2024
- First submitted
- 17 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kwon E, Sutton AE, O'Rourke MC. Chronic Sinusitis. 2026 Jan 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441934/
PubMed 28722963Akhondi H, Sutton AE, Rajasurya V. Fungal Sinusitis. 2026 May 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK551496/
PubMed 31855340
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sinonasal Risk Factors for Occurrence of Unilateral Versus Bilateral Allergic Fungal Rhinosinusitis
- ClinicalTrials.gov ID
- NCT06376071
- Acronym / sponsor ID
- fungal rhinosiusitis
- Conditions
- Allergic Fungal Rhinosinusitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess Sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhino sinusitis regarding::
- anatomical variations and correlate radiological finding with intraoperative finding.
- other associated factors like demographic ,environmental, immunological and climatic risk factors .
Detailed description
Introduction Allergic fungal rhinosinusitis (AFRS) is a subtype of CRS with nasal polyposis (CRSwNP) that is characterized by eosinophilic mucin within expanded sinus cavities and immunoglobulin E (IgE)-mediated type 1 hypersensitivity to fungal elements. This noninvasive disease process typically affects immunocompetent, younger patients in geographic regions with warm temperatures and high humidity, which facilitate fungal proliferation.
AFRS has a worldwide distribution pattern with varying prevalence. AFRS is presented in variable rates in different climatic, socioeconomic, and geographic factors. The disease prevalence showed predilection toward climatic factors
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be divided into two groups: Group (A): including patients with unilateral allergic fungal rhinosinusitis. Group (B): including patients with bilateral allergic fungal rhinosinusitis. Then all patient will subjected to EFSS under general anathesia with wide sinusotomics where intraoperative collection of data will be done as the follow
Key inclusion criteria (2 listed)
- Denovo cases . any Age Any sex. Patients diagnosed with unilateral or bilateral allergic fungal rhino sinusitis, meeting classic Bent and Kuhn criteria for AFRS:(10).
- Nasal polyposis. Fungi on staining. Eosinophilic mucin without fungal invasion into sinus tissue., Type I hypersensitivity to fungi. Characteristic radiologic findings with soft-tissue differential densities on computed tomographic (CT) scanning
Key exclusion criteria (1 listed)
- Diagnosis of benign or malignant neoplasm of the sinonasal cavity. Prior radiation therapy to the head or neck. Significant prior facial trauma. Autoimmune disorder. Craniofacial anomaly. Fungus ball. Immunodeficiency. Cystic fibrosis. Patients unfit for surgery. Previous nasal surgery or recurrent cases .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional endoscopic sinus surgeryfunctional endoscopic sinus surgery for diagnosis the disease | Diagnostic test | – |
Primary outcome
Sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhinosinusitis
Time frame: baseline
analysis of the risk factors of unilateral versus bilateral allergic fungal rhinosinusitis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Background: PubMed 28722963Kwon E, Sutton AE, O'Rourke MC. Chronic Sinusitis. 2026 Jan 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441934/
- Results publication: PubMed 31855340Akhondi H, Sutton AE, Rajasurya V. Fungal Sinusitis. 2026 May 26. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK551496/
- Indian J Otolaryngol Head Neck Surg. 2023 Jun;75(2):571-578. doi: 10.1007/s12070-022-03338-0. Epub 2022 Dec 17Link provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Fungal Rhinosinusitis, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact khater nosir sayed, master (01011973180, khatrsnyr289@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sinonasal risk factors for occurrence of unilateral versus bilateral allergic fungal rhinosinusitis (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06376071, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.