Budesonide Nasal Irrigation Versus Fluticasone Propionate Nasal Spray in Treating Allergic Rhinitis Patients

Phase 4

Completed

• Conditions: Nasal Allergy
• Interventions: Other: 0.9% saline for nasal irrigation.; Drug: Fluticasone propionate nasal spray.; Drug: Budesonide buffered with 0.9% isotonic saline.

• Registration Number: NCT06858423
• Lead Sponsor: Benha University

Brief Summary

Budesonide is a medication of the corticosteroid type. Available as an inhaler, nebulization solution, The inhaled form is used in the long-term management of asthma and chronic obstructive pulmonary disease is used for allergic rhinitis and nasal polyps fluticasone propionate

Detailed Description

The current study aims to compare between results of budesonid nasal irrigation and fluticasone nasal spray in the treatment of adult patients with Allergic Rhinitis.

Study Timeline

• Study Start: 2023-08-15
• Primary Completion: 2024-03-31
• Study Completion: 2024-05-31
• Status Verified: 2025-02
• Study First Submitted: 2025-02-14
• Study First Submitted QC: 2025-02-27
• Last Update Submitted: 2025-02-27
• Study First Posted: 2025-03-05
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Adult age between 18 and 60 years old.
• Patients with allergic rhinitis evidence by past skin prick testing. Patients were given a skin prick test with a panel of dog, cat, Dermatophagoides farinae, D pteronyssinus, Alternaria, Penicillium, Hormodendron, Aspergillus, grass pollen mix, tree pollen mix, and ragweed allergen extracts (100,000 Allergen Unit/mL). Histamine, 10 mg/mL, was used as a positive control, and the diluent was used as the negative control. A positive reaction was defined as a wheal diameter at least 3 mm greater than the diluent control and/or at least a 50-mm flare (ie, erythema measured as the sum of the greatest diameter and the perpendicular diameter through the midpoint of the greatest diameter)

Exclusion Criteria

• Patients who had autoimmune diseases or any immune compromised diseases including diabetes, chemotherapy.
• Patients with a history of nasal surgery.
• Patients who received systemic or topical corticosteroids, herbal drugs, beta blocking agent within the previous month of enrolment.
• Patients with asthma and COPD, nasal bleeding, obstructing nasal polyps, paranasal sinus.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (Saline Group)	0.9% saline for nasal irrigation.	120 patients used 0.9% saline for nasal irrigation.
Group B (Fluticasone Propionate Nasal Spray)	Fluticasone propionate nasal spray.	120 patients received fluticasone propionate nasal spray.
Group C (Budesonide Nasal Irrigation)	Budesonide buffered with 0.9% isotonic saline.	120 patients received budesonide buffered with 0.9% isotonic saline.

Primary Outcome Measures

Name	Time	Method
Clinical improvement	1 month	improvement measured by pre- and post-treatment SNOT score

Secondary Outcome Measures

Name	Time	Method
Endoscopic examination improvement	1 month	by comparing pre and post treatment lund\*Mackay score

Trial Locations

Locations (1)

Benha University Hospitals - Otolaryngology department; 🇪🇬 Banhā, Qalyobia, Egypt