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NCT Number: NCT06858423

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Benha University Hospitals - Otolaryngology department

Banhā, Qalyobia, 6460001, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Budesonide buffered with 0.9% isotonic saline.

Drug

120 patients received budesonide buffered with 0.9% isotonic saline.

Fluticasone propionate nasal spray.

Drug

120 patients received fluticasone propionate nasal spray.

0.9% saline for nasal irrigation.

Other

120 patients used 0.9% saline for nasal irrigation.

Primary outcomes

  1. Clinical improvement

    Time frame: 1 month

    improvement measured by pre- and post-treatment SNOT score

Secondary outcomes

  1. Endoscopic examination improvement

    Time frame: 1 month

    by comparing pre and post treatment lund*Mackay score

Other outcomes

  1. Effects on serum cortisol level

    Time frame: 1 month

    Monitoring of pre and post treatment measurements of e morning serum cortisol level

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 5, 2025
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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