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

Budesonide Nasal Irrigation Versus Fluticasone Propionate Nasal Spray in the Treatment of Adult Patients With Allergic Rhinitis

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06858423
Enrollment
360
Registered
2025-03-05
Start date
2023-08-15
Completion date
2024-05-31
Last updated
2025-03-05

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

Conditions

Nasal Allergy

Keywords

allergic rhinitis, Budesonide, luticasone propionate

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.

Interventions

DRUGBudesonide buffered with 0.9% isotonic saline.

120 patients received budesonide buffered with 0.9% isotonic saline.

DRUGFluticasone propionate nasal spray.

120 patients received fluticasone propionate nasal spray.

OTHER0.9% saline for nasal irrigation.

120 patients used 0.9% saline for nasal irrigation.

Sponsors

Benha University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical improvement1 monthimprovement measured by pre- and post-treatment SNOT score

Secondary

MeasureTime frameDescription
Endoscopic examination improvement1 monthby comparing pre and post treatment lund\*Mackay score

Other

MeasureTime frameDescription
Effects on serum cortisol level1 monthMonitoring of pre and post treatment measurements of e morning serum cortisol level

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026