Efficacy of Intranasal corticosteroid spray versus placebo in post-operative endoscopic sinus surgery of patient with sinus fungal ball

Efficacy of Intranasal corticosteroid spray versus placebo in post-operative endoscopic sinus surgery of patient with sinus fungal ball, Multi-center double blind randomized placebo controlled trials

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

TCTR

Registry ID

TCTR20230310001

Enrollment

Registered

2023-03-10

Start date

2023-03-15

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The role of INCS in post operative sinus surgery in patient with sinus fungal ball. Sinus fungal ball, Intranasal corticosteroid, Post operative endoscopic sinus surgery

Interventions

Avamys is an intranasal corticosteroid that we use in this study because it has a low bioavailability. Moreover it is one of the drug lists in Thailand National List of Essential Medicines (NLEM) that

s compounds of glucose anhydrous, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate and purified water, which are the stabilizer and give the moist in sinuses. We define t

Active Comparator Drug,Placebo Comparator Drug

Intranasal corticosteroid,Placebo

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age equal or more than 18 years old 2. Imaging and intra-operative sinuses finding associated with sinus fungal ball 3. Patient consent to join the research project

Exclusion criteria

Exclusion criteria: 1. Pathology show invasive fungal sinusitis 2. Previous sinus surgery 3. Previous radiation therapy at head and neck 4. Having underlying diseases such as Ciliary dyskinesia, Cystic fibrosis 5. Taking immunosuppressive drugs 6. Patient with allergic rhinitis who need to regularly use intranasal corticosteroid 7. Patient who taking these drug before surgery 7.1. Oral or IV corticosteroid 4 weeks 7.2. Topical corticosteroid 2 weeks 7.3. Intramuscular corticosteroid 4 week 8. Patient who have fluticasone furoate drug allergy 9. Pregnancy 10. Breast feeding 11. Patient deny to consent the research project

Design outcomes

Primary

Measure	Time frame
Endoscopic score 3 months Lund Kennedy endoscopic score	—

Secondary

Measure	Time frame
chronic rhinosinusitis health-related quality-of-life outcome (HRQoL) measure 3 months SNOT-22,self questionnaire for evaluate severity of sinus symptoms 3 months VAS score	—

Countries

Thailand

Contacts

Public ContactTanya Thanakhamthorn

Ramathibodi hospital, Mahidol university

t.thanakhamthorn@gmail.com0894630097

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026