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

NCT ID: NCT06858423

Last Updated: 2025-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-15

Study Completion Date

2024-05-31

Brief Summary

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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

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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.

Conditions

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Nasal Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A (Saline Group)

120 patients used 0.9% saline for nasal irrigation.

Group Type PLACEBO_COMPARATOR

0.9% saline for nasal irrigation.

Intervention Type OTHER

120 patients used 0.9% saline for nasal irrigation.

Group B (Fluticasone Propionate Nasal Spray)

120 patients received fluticasone propionate nasal spray.

Group Type EXPERIMENTAL

Fluticasone propionate nasal spray.

Intervention Type DRUG

120 patients received fluticasone propionate nasal spray.

Group C (Budesonide Nasal Irrigation)

120 patients received budesonide buffered with 0.9% isotonic saline.

Group Type EXPERIMENTAL

Budesonide buffered with 0.9% isotonic saline.

Intervention Type DRUG

120 patients received budesonide buffered with 0.9% isotonic saline.

Interventions

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Budesonide buffered with 0.9% isotonic saline.

120 patients received budesonide buffered with 0.9% isotonic saline.

Intervention Type DRUG

Fluticasone propionate nasal spray.

120 patients received fluticasone propionate nasal spray.

Intervention Type DRUG

0.9% saline for nasal irrigation.

120 patients used 0.9% saline for nasal irrigation.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Eslam Farid Abu Shady ,MD

Lecturer and consultant of otolaryngology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Benha University Hospitals - Otolaryngology department

Banhā, Qalyobia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MS-8-8-2023

Identifier Type: -

Identifier Source: org_study_id

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