Background: The safety and efficacy of fluticasone propionate (FP) nasal spray and mometasone furoate monohydrinate (MFM) nasal spray for the symptoms of seasonal and perennial allergic rhinitis have been previously demonstrated separately in several clinical studies. The objective of this pilot study was to compare the efficacy fluticasone propionate nasal spray and mometasone furoate nasal spray in patients with allergic rhinitis.
Materials and methods: For this study, 75 perennial allergic rhinitis patients were randomly assigned to two treatment groups: MFM group and an FP group. Treatment was provided for 4 weeks and 8 weeks after the treatment begining. The effects of the two agents were compared using the total nasal symptom scores (TNSSs).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031419240N2
Registration date:2016-04-28, 1395/02/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-28, 1395/02/09
Registrant information
Name
Omid Gholami
Name of organization / entity
Sabzevar University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 4444 6070
Email address
gholamio@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Sabzevar University Of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-03-19, 1394/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison between Floticasone and Mometasone nasal sprays on allergic rhinitis symptoms
Public title
comparison between two corticosteroid nasal spray on allergic rhinitis symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) having allergic rhinitis based on clinical exams and questionnaire; 2) having dermatitis allergy to allergen.
Exclusion criteria:
1) having infection in two previous weeks; 2) having upper/ lower respiratory infection in two previous weeks; 3) using inhaled steroids in two previous weeks; 4) having nasal polyp.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sabzevar University of medical sciences
Street address
Sabzevar University of Medical Sciences- Asadabadi Street- Sabzevar- Iran
City
Sabzevar
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
Medsab.Rec.93.57
Health conditions studied
1
Description of health condition studied
Allergic rhinitis
ICD-10 code
J30.4
ICD-10 code description
Allergic rhinitis, unspecified
Primary outcomes
1
Description
Nasal congestion
Timepoint
0 & 4 & 8 weeks
Method of measurement
TNSS score
2
Description
Nasal itching
Timepoint
0 & 4 & 8 weeks
Method of measurement
TNSS score
3
Description
Postnasal drip
Timepoint
0 & 4 & 8 weeks
Method of measurement
TNSS score
4
Description
Runny nose
Timepoint
0 & 4 & 8 weeks
Method of measurement
TNSS score
5
Description
Smelling disorders
Timepoint
0 & 4 & 8 weeks
Method of measurement
TNSS score
6
Description
Sneezing
Timepoint
0 & 4 & 8 weeks
Method of measurement
TNSS score
Secondary outcomes
empty
Intervention groups
1
Description
Fluticasone nasal spray 200 micro grams/day (2 puff in each nostril) for 8 weeks
Category
Treatment - Drugs
2
Description
Mometasone nasal spray 100 micro grams/day (2 puff in each nostril) for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Vasei Hospital
Full name of responsible person
Mahshid Sadat Mirmoezi
Street address
Sabzevar Vasei Hospital
City
Sabzevar
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Sabzevar University Of Medical Sciences
Full name of responsible person
Mohammad Mohammadzadeh
Street address
Deputy of Research and Technology, Sabzevar University of Medical Sciences
City
Sabzevar
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Sabzevar 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
Sabzevar University of medical sciences
Full name of responsible person
Mahshid sadat Mirmoezi
Position
Student
Other areas of specialty/work
Street address
Sabzevar
City
Sabzevar
Postal code
Phone
+98 51 5725 2216
Fax
Email
mahshid.mirmoezi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Omid Gholamه
Position
Assisstant Professor
Other areas of specialty/work
Street address
Faculty of Medicine, Deputy of Education, Sabzevar University of Medical Sciences
City
Sabzevar
Postal code
Phone
+98 51 4444 6070
Fax
Email
omidghphd@gmail.com; dromidgholami@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sabzevar university of medical sciences
Full name of responsible person
Omid Gholami
Position
Assisstant professor
Other areas of specialty/work
Street address
Faculty of Medicine, Deputy of Education, Sabzevar University of Medical Sciences
City
Sabzevar
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)