The purpose of this randomized double- blind controlled study is to determine the efficacy of itraconazole in the treatment of patients with Allergic Fungal Sinusitis (AFS). These patients, after endoscopic sinus surgery and routine therapy consisting of prednisolone (1mg/kg body weight for a period of ten days), nasal spray corticosteroid and Amphotericin (100 mg/ml) in distilled water for nasal irrigation will be divided in two groups. The control group will receive placebo and intervention group Itraconazole (200 mg daily) for two months after surgery. Patients with a history of prior sinus surgery, systemic disease, pregnant or lactating women are excluded from this study. A total of 36 patients between 15 and 65 years old who suffer from AFS in Khuzestan will be enrolled. At the end of the 3rd month diagnostic nasal endoscopy and CT scan will be done and the patients will fill a questionnaire of quality of life (Snot 20).
General information
Acronym
Allergic Fungal Sinusitis (AFS)
IRCT registration information
IRCT registration number:IRCT201204049375N1
Registration date:2013-04-09, 1392/01/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-09, 1392/01/20
Registrant information
Name
Soheila Nikakhlagh
Name of organization / entity
Ahvaz Jondishapoor University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3292 1838
Email address
nikakhlagh-s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research affairs, Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2011-01-21, 1389/11/01
Expected recruitment end date
2013-06-20, 1392/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A placebo-controlled double-blind randomized trial of itraconazole for Allergic Fungal Sinusitis
Public title
The effect of itraconazole in the treatment of allergic fungal sinusitis
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 15 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
College Town, Golestan
City
Ahvaz
Postal code
6135715794
Approval date
2011-12-27, 1390/10/06
Ethics committee reference number
314
Health conditions studied
1
Description of health condition studied
fungal sinusitis
ICD-10 code
J32
ICD-10 code description
chronic sinusitis
Primary outcomes
1
Description
Therapeutic effect of Itraconazol on fungal sinusitis
Timepoint
three months after intervention
Method of measurement
Endoscopic and CT scan findings
Secondary outcomes
1
Description
quality of life
Timepoint
three months after intervention
Method of measurement
Snot-20 questionnaire
Intervention groups
1
Description
Intervention: Prednisolone 1mg/kg for 10 days followed by nasal corticosteroid and topical irrigation with amphotericin plus itraconazole 200 mg daily for two months
Category
Treatment - Drugs
2
Description
Control group: Prednisolone 1 mg/kg for 10 days followed by nasal corticosteroid and topical irrigation with amphotericin plus placebo daily for two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr. Soheila Nikakhlagh
Street address
Otolaryngology Department, Imam Khomeini Hospital, Azadegan street
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi
Street address
Vice chancellor for research affairs , College town , Golestan
City
Ahvaz
Grant name
معاونت پژوهشی
Grant code / Reference number
u-90204
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapour University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Dr. Soheila Nikakhlagh
Position
Associate Prof.
Other areas of specialty/work
Street address
Otolaryngology Department ,Imam Khomeini Hospital, Azadegan street
City
Ahvaz
Postal code
6135715794
Phone
+98 61 1222 2114
Fax
+98 61 1292 1838
Email
nikakhlagh-s@ajums.ac.ir: nikakhlagh.s@gmail.com
Web page address
www.sakinik.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Dr. Soheila Nikakhlagh
Position
Associate Prof.
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Azadegan street
City
Ahvaz
Postal code
6135715794
Phone
+98 61 1222 2114
Fax
+98 61 1292 1838
Email
nikakhlagh-s@ajums.ac.ir; nikakhlagh.s@gmail.com
Web page address
www.sakinik.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapour University of Medical Sciences
Full name of responsible person
Dr. Soheial Nikakhlagh
Position
Associate Prof.
Other areas of specialty/work
Street address
Imam Khomeini Hospital, Azadegan street
City
Ahvaz
Postal code
6135715794
Phone
+98 61 1222 2114
Fax
+98 61 1292 1838
Email
nikakhlagh-s@ajums.ac.ir; nikakhlagh.s@gmail.com
Web page address
www.sakinik.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)