To evaluate and compare the effectiveness of combination therapy with fluticasone propionate and azelastine hydrochloride nasal spray versus fluticasone propionate monotherapy in improving the symptoms of patients with allergic rhinitis.
Design
Randomized, single-blind, two-arm parallel group clinical trial with concealed block randomization. A total of 80 patients will be enrolled and randomly allocated in a 1:1 ratio to treatment groups.
Settings and conduct
This study is conducted at the outpatient otolaryngology and head & neck surgery clinic of Imam Reza Hospital, affiliated with Tabriz University of Medical Sciences, Iran.
Participants/Inclusion and exclusion criteria
Participants must meet the following conditions: age above 12 years, SFAR score ≥ 7 as a diagnostic indicator of allergic rhinitis, residency in East Azerbaijan province, presence of persistent allergic rhinitis symptoms based on clinical history, willingness to attend all study visits and follow-ups, and provision of a signed informed consent form to participate in the research.
Patients will be excluded if they have had an upper or lower respiratory tract infection in the past two weeks, structural nasal abnormalities such as severe septal deviation, polyps, or tumors, or a history of previous nasal or paranasal sinus surgery.
Intervention groups
Intervention Group: Forty patients in this group will receive a combination nasal spray consisting of fluticasone propionate (50 mcg) and azelastine hydrochloride (140 mcg) daily. The medication will be administered in a standard dose as prescribed by the physician.
Control Group: Forty patients in this group will receive a nasal spray containing fluticasone propionate (50 mcg) alone, which represents the current standard therapy.
Main outcome variables
Change in allergic rhinitis symptom severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250927067374N1
Registration date:2025-09-29, 1404/07/07
Registration timing:prospective
Last update:2025-09-29, 1404/07/07
Update count:0
Registration date
2025-09-29, 1404/07/07
Registrant information
Name
Mahdi Zohouri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 930 226 1479
Email address
zohouri.mahdi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-23, 1404/08/01
Expected recruitment end date
2026-03-19, 1404/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Adding Azelastine Hydrochloride to Fluticasone Propionate Nasal Spray in the Treatment of Allergic Rhinitis
Public title
Effect of Combination Nasal Spray of Fluticasone and Azelastine in Improving Symptoms of Allergic Rhinitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
SFAR score ≥ 7 indicating allergic rhinitis
Residency in East Azerbaijan province
Presence of persistent symptoms of allergic rhinitis based on medical history
Signed informed consent to participate in the study
Willingness to adhere to follow-up visits throughout the study period
Exclusion criteria:
Upper or lower respiratory tract infection within two weeks prior to the first visit
Structural nasal abnormalities such as severe septal deviation, nasal polyps, or tumors
History of previous nasal or paranasal sinus surgery
Need for surgical treatment during the study period
Use of systemic or oral corticosteroids within 30 days prior to the first visit
Pregnant or breastfeeding women
Presence of serious underlying diseases such as asthma, diabetes, cancer, or rheumatic diseases
Unreliable or uncooperative patients, such as those with severe depression or intellectual disability
Known allergy to antihistamines or corticosteroids
Age
From 12 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization will be performed using a block randomization method with variable block sizes (4 and 6) and an allocation ratio of 1:1. The random sequence will be generated by an independent statistician using computer software and kept secure in sequentially numbered, opaque, sealed envelopes (SNOSE) to ensure allocation concealment. After confirming eligibility, the next envelope in sequence will be opened, and the patient's group assignment will be determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
Since the principal investigator is also the treating physician, blinding is not feasible for them; however, data collection and statistical analysis will be performed by an independent blinded assessor, making this a single-blind clinical trial.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Vice chancellor for research, Tabriz University of Medical Sciences
Street address
Vice chancellor for research, Tabriz University of Medical Sceinces, Daneshgah Square
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2025-09-14, 1404/06/23
Ethics committee reference number
IR.TBMZED.REC.1404.406
Health conditions studied
1
Description of health condition studied
Allergic rhinitis
ICD-10 code
J30.9
ICD-10 code description
Allergic rhinitis, unspecified
Primary outcomes
1
Description
Change in Total Symptom Score
Timepoint
Baseline and week 4 after treatment
Method of measurement
Four-point symptom scale (FDA criteria for allergic rhinitis)
Secondary outcomes
1
Description
Change in ocular symptoms
Timepoint
Baseline and week 4 after treatment
Method of measurement
Four-point symptom scale (FDA criteria for allergic rhinitis)
2
Description
Patient satisfaction with treatment
Timepoint
4 week after treatment
Method of measurement
Visual Analog Scale
Intervention groups
1
Description
Intervention group: Patients in this group will receive a combination nasal spray containing fluticasone propionate (50 mcg) and azelastine hydrochloride (140 mcg), administered daily in a standard dosage as prescribed by the physician.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group will receive a nasal spray containing fluticasone propionate (50 mcg) alone, representing the current standard of care.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Dr. Shahin Abdollahi Fakhim
Street address
ENT ward, floor 2, Imam-Reza hospital, In front of the university's main building, Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 914 372 1343
Fax
+98 41 3335 2073
Email
imamreza@tbzmed.ac.ir
Web page address
https://imamreza.tbzmed.ac.ir/?PageID=734
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Khosrow Adibkia
Street address
Vice chancellor for research, Tabriz University of medical sceinces, Daneshgah square
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
adibkia@tbzmed.ac.ir
Web page address
https://researchvice.tbzmed.ac.ir/Page-497
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Mahdi Zohouri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Department of ENT, floor 2, Emam-Reza hospital, Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 930 226 1479
Fax
Email
zohouri.mahdi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahdi Zohouri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Department of ENT, floor 2, Emam-Reza hospital, Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 930 226 1479
Fax
Email
zohouri.mahdi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mahdi Zohouri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ear, Nose, and Throat
Street address
Department of ENT, floor 2, Emam-Reza hospital, Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 930 226 1479
Fax
Email
zohouri.mahdi@gmail.com
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study data is categorized and coded with no identifiable individuals.
When the data will become available and for how long
Access to study data after publication of the result is available in the journal.
To whom data/document is available
Anyone interested in using the data can access the study data.
Under which criteria data/document could be used
Study data can be used for comparison with other results.
From where data/document is obtainable
Refer to the study's scientific or public accountability person for data.
What processes are involved for a request to access data/document
The request will be sent by email to person responsible for scientific or public inquiries.