A randomized controlled trial of low dose MACROLIC (AZITHROMYCIN)in the prevention of symptom relapse in CHRONIC RHINOSINUSITIS after endoscopic surgery –EMAM KHOMEINI HOSPITAL 2010-2012
We want to study azithromycin effect on symptom relief of chronic rhinosinusitis after surgery.
Inclusion criteria: chronic rhinosinositis with or without polyposis after endoscopic surgery
exclusion criteria : immunodeficiency , cystic fibrosis
study population : known cases of rhinosinusitis after endoscopic surgery
After endoscopic surgery , control group will receive standard conventional treatment (fluticasone spray + normal saline washing TDS ) . intervention group will receive conventional treatment (fluticasone spray + normal saline washing TDS )+ azithromycin 250 mg daily for 3 month
Before and 3 month after surgery patients will fill SNOT 22 standard questionnaire .and outcomes(symptom relief ) will compare between these 2 groups.
General information
Acronym
Azithro Trial Sinusitis (ATS)
IRCT registration information
IRCT registration number:IRCT201105146468N1
Registration date:2011-06-27, 1390/04/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-27, 1390/04/06
Registrant information
Name
Amin Amali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1628
Email address
a_amali@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2011-06-04, 1390/03/14
Expected recruitment end date
2012-06-04, 1391/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized controlled trial of low dose MACROLIC (AZITHROMYCIN)in the prevention of symptom relapse in CHRONIC RHINOSINUSITIS after endoscopic surgery –EMAM KHOMEINI HOSPITAL 2010-2012
Public title
Azithromycin effect on chronic sinusitis symptoms after endoscopic surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : chronic rhinosinositis with or without polyposis after endoscopic surgery
exclusion criteria : immunodeficiency ; cystic fibrosis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Science
Street address
16 AZAR street; TEHRAN
City
TEHRAN
Postal code
Approval date
2011-04-11, 1390/01/22
Ethics committee reference number
90/د/130/42
Health conditions studied
1
Description of health condition studied
chronic sinusitis
ICD-10 code
J32
ICD-10 code description
Chronic sinusitis
Primary outcomes
1
Description
symptom severity
Timepoint
before and 3 month after initiation of therapy
Method of measurement
patients will fill SNOT22 symptom questionnare
Secondary outcomes
1
Description
diarrhea,rash,abdominal pain,palpitation,melena
Timepoint
during therapy
Method of measurement
patients symptoms and signs
Intervention groups
1
Description
intervention : azithromycine 250 mg daily for 3 month + conventional therapy (fluticasone spray + normal salin washing TDS )
control : fluticasone spray + normal salin washing TDS
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
VALIASR ENT center. EMAM KHOMEINI hospital
Full name of responsible person
DR.AMIN AMALI
Street address
EMAM KHOMEINI hospital; KESHAVARZ avenue; TEHRAN
City
TEHRAN
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masud Younesian
Street address
POORSINA street ; TEHRAN
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?