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

February 27, 2025 updated by: Eslam Farid Abu Shady ,MD, Benha University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Qalyobia
      • Banhā, Qalyobia, Egypt, 6460001
        • Benha University Hospitals - Otolaryngology department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group A (Saline Group)
120 patients used 0.9% saline for nasal irrigation.
Other: 0.9% saline for nasal irrigation.
120 patients used 0.9% saline for nasal irrigation.
Experimental: Group B (Fluticasone Propionate Nasal Spray)
120 patients received fluticasone propionate nasal spray.
Drug: Fluticasone propionate nasal spray.
120 patients received fluticasone propionate nasal spray.
Experimental: Group C (Budesonide Nasal Irrigation)
120 patients received budesonide buffered with 0.9% isotonic saline.
Drug: Budesonide buffered with 0.9% isotonic saline.
120 patients received budesonide buffered with 0.9% isotonic saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical improvement
Time Frame: 1 month
improvement measured by pre- and post-treatment SNOT score
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopic examination improvement
Time Frame: 1 month
by comparing pre and post treatment lund*Mackay score
1 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effects on serum cortisol level
Time Frame: 1 month
Monitoring of pre and post treatment measurements of e morning serum cortisol level
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2023

Primary Completion (Actual)

March 31, 2024

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

February 27, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-8-8-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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