To assess the effects of fluticasone nasal spray on symptoms and serum IgE of patients with allergic sinonasal polyposis
Design
This is a non-blinded, single-group clinical trial. The trial is performed on 34 eligible patients with allergic sinonasal polyposis referring to Ghaem Hospital and Imam Reza Hospital in Mashhad from December 2016 to March 2018. Before intervention, clinical symptoms are recorded, Sino-nasal Outcome Test-22 (SNOT22) is completed, and serum IgE is measured. Then, fluoticasone nasal spray with the Flomist brand is prescribed for patients for 4 weeks. At the end of the intervention, the patients will be evaluated in terms of serum IgE levels and clinical symptoms, and SNOT22 will be completed again.
Settings and conduct
The trial is performed in the ENT Clinic of Ghaem Hospital and Imam Reza Hospital of Mashhad. The physician responsible for assessing the clinical symptoms and completing SNOT22 as well as the expert in laboratory tests were blind to the study.
Participants/Inclusion and exclusion criteria
Main inclusion criteria comprise of grade 2 nasal polyposis or lower grades and positive skin prick test. Main exclusion criteria involve pregnancy and application of nasal or systemic corticosteroid during the past month.
Intervention groups
This is a single-group study. Every 12 hours, the patients receive 2 puffs of fluoticasone nasal spray (Flomist brand) in each nostril for 4 weeks.
Main outcome variables
Serum lgE level and Sino-nasal Outcome Test-22 results
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140519017756N40
Registration date:2018-03-14, 1396/12/23
Registration timing:registered_while_recruiting
Last update:2018-03-14, 1396/12/23
Update count:0
Registration date
2018-03-14, 1396/12/23
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effects of fluticasone nasal spray on clinical symptoms and serum IgE of patients with allergic sinonasal polyposis: A clinical trial
Public title
Effects of fluticasone nasal spray on clinical symptoms and serum IgE
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
grade 2 nasal polyposis or lower grades
positive skin prick test
signed informed consent
age more than 18 years old
Exclusion criteria:
pregnancy
use of nasal or systemic corticosteroid during the past month
Age
From 18 years old
Gender
Both
Phase
1
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
34
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
The physician responsible for assessing the clinical symptoms and completing SNOT22 as well as the expert in laboratory tests were blind to the study.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138735499
Approval date
2016-08-03, 1395/05/13
Ethics committee reference number
IR.MUMS.fm.REC.1395.202
Health conditions studied
1
Description of health condition studied
allergic sinonasal polyposis
ICD-10 code
J.33
ICD-10 code description
Nasal polyp
Primary outcomes
1
Description
lgE serum level
Timepoint
Before and after intervention
Method of measurement
laboratory kit to measure lgE serum level
2
Description
Sino-nasal Outcome Test-22 score
Timepoint
Before and after intervention
Method of measurement
Sino-nasal Outcome Test-22
Secondary outcomes
1
Description
Change in Polyps Grade
Timepoint
Before and after intervention
Method of measurement
Rhinoscopy and nasal endoscopy
Intervention groups
1
Description
Intervention group: Every 12 hours, the patients receive 2 puffs of fluoticasone nasal spray (Flomist brand) in each nostril for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
ENT Clinic of Ghaem Hospital
Full name of responsible person
Dr Mehdi Bakhshayi
Street address
Ahmadabad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138735499
Phone
+98 51 3840 0000
Email
bakhshaeem@mums.ac.ir
2
Recruitment center
Name of recruitment center
ENT Clinic of Imam Reza Hospital
Full name of responsible person
Dr Shahriar Mohammadreza Sharifian
Street address
Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138735499
Phone
+98 51 3802 2000
Email
SharifianSh@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138735499
Phone
+98 51 3282 3255
Email
tafaghodim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohammadsadegh Alimardani
Position
ENT specialist
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Reza Hospital, Daneshgah Ave.
City
Mashhahd
Province
Razavi Khorasan
Postal code
9138735499
Phone
+98 51 3802 2000
Email
bakhshaeem@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Shahriar Mohammadreza Sharifian
Position
ENT specialist
Latest degree
Specialist
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Imam Reza Hospital, Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9138735499
Phone
+98 51 3802 2000
Email
SharifianSh@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
Translator
Latest degree
Master
Other areas of specialty/work
Others
Street address
Ghaffari Ave.
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5680
Email
roozgar@BUMS.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Deidentified Individual Participant Data Set will be provided in an excel file and provided on the research project website: http://yon.ir/PkRy6
When the data will become available and for how long
when the study is completed and for 5 years
To whom data/document is available
Those who refer to the project's website
Under which criteria data/document could be used
Only for research purposes
From where data/document is obtainable
the research website addressed at http://yon.ir/yon.ir/PkRy6
What processes are involved for a request to access data/document
If a request is delivered via email, the deidentified data file will be sent within 10 days.