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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250927067374N1

Enrollment

Registered

2025-09-29

Start date

2025-10-23

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic rhinitis. Allergic rhinitis, unspecified

Interventions

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

Eligibility

Sex/Gender

All

Age

12 Years to No maximum

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahdi Zohouri

Tabriz University of Medical Sciences

zohouri.mahdi@gmail.com+98 930 226 1479

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026