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IRCT20250927067374N1 IRCT 2025-09-29 Tabriz University of Medical Sciences Effect of Combination Nasal Spray of Fluticasone and Azelastine in Improving Symptoms of Allergic Rhinitis The Effect of Adding Azelastine Hydrochloride to Fluticasone Propionate Nasal Spray in the Treatment of Allergic Rhinitis 2025-10-23 anticipated 80 Complete https://irct.ir/trial/86454 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Allergic rhinitis. Intervention 1: 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. Intervention 2: Control group: Patients in this group will receive a nasal spray containing fluticasone propionate (50 mcg) alone, representing the current standard of care. Yes - There is a plan to make this available What will be shared: Study data is categorized and coded with no identifiable individuals. When: Access to study data after publication of the result is available in the journal. To whom: Anyone interested in using the data can access the study data. Conditions: Study data can be used for comparison with other results. Where to obtain: Refer to the study's scientific or public accountability person for data. How to obtain: The request will be sent by email to person responsible for scientific or public inquiries. Comments:
public Mahdi Zohouri
Department of ENT, floor 2, Emam-Reza hospital, Daneshgah street
Tabriz Iran (Islamic Republic of) 5166614756 +98 930 226 1479 zohouri.mahdi@gmail.com Tabriz University of Medical Sciences scientific Mahdi Zohouri
Department of ENT, floor 2, Emam-Reza hospital, Daneshgah street
Tabriz Iran (Islamic Republic of) 5166614756 +98 930 226 1479 zohouri.mahdi@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) 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 12 years no limit Both 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 J30.9 Allergic rhinitis, unspecified Treatment - Drugs Treatment - Drugs 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. Control group: Patients in this group will receive a nasal spray containing fluticasone propionate (50 mcg) alone, representing the current standard of care. Change in Total Symptom Score. Timepoint: Baseline and week 4 after treatment. Method of measurement: Four-point symptom scale (FDA criteria for allergic rhinitis). Change in ocular symptoms. Timepoint: Baseline and week 4 after treatment. Method of measurement: Four-point symptom scale (FDA criteria for allergic rhinitis). Patient satisfaction with treatment. Timepoint: 4 week after treatment. Method of measurement: Visual Analog Scale. Tabriz University of Medical Sciences Approved 2025-09-14 Ethics committee of Vice chancellor for research, Tabriz University of Medical Sciences Vice chancellor for research, Tabriz University of Medical Sceinces, Daneshgah Square Tabriz East Azarbaijan Iran (Islamic Republic of)