The effect of itraconazole in the treatment of allergic fungal sinusitis

A placebo-controlled double-blind randomized trial of itraconazole for Allergic Fungal Sinusitis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201204049375N1

Enrollment

Registered

2013-04-09

Start date

2011-01-21

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

fungal sinusitis. chronic sinusitis

Interventions

Intervention 1: Intervention: Prednisolone 1mg/kg for 10 days followed by nasal corticosteroid and topical irrigation with amphotericin plus itraconazole 200 mg daily for two months. Intervention 2: C

Treatment - Drugs

Intervention: Prednisolone 1mg/kg for 10 days followed by nasal corticosteroid and topical irrigation with amphotericin plus itraconazole 200 mg daily for two months

Control group: Prednisolone 1 mg/kg for 10 days followed by nasal corticosteroid and topical irrigation with amphotericin plus placebo daily for two months

Eligibility

Sex/Gender

All

Age

15 Years to 65 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients with diagnosis of allergic fungal sinusitis based on culture and pathology. Exclusion criteria: history of previous sinus surgery, history of systemic disease, pregnant or nursing mother, patient who display rising of hepatic enzymes during treatment with itraconazole.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Therapeutic effect of Itraconazol on fungal sinusitis. Timepoint: three months after intervention. Method of measurement: Endoscopic and CT scan findings.	—

Secondary

Measure	Time frame
Quality of life. Timepoint: three months after intervention. Method of measurement: Snot-20 questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Soheila Nikakhlagh

Ahvaz Jundishapour University of Medical Sciences

nikakhlagh-s@ajums.ac.ir: nikakhlagh.s@gmail.com+98 61 1222 2114

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026