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

Benha University

Status and phase: Completed; Phase 4

Conditions: Nasal Allergy

Treatments: Drug: Budesonide buffered with 0.9% isotonic saline.; Other: 0.9% saline for nasal irrigation.; Drug: Fluticasone propionate nasal spray.

Study type: Interventional

Funder types: Other

Identifiers

NCT06858423

MS-8-8-2023

Details and patient eligibility

About

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

Full 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.

Enrollment: 360 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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360 participants in 3 patient groups, including a placebo group

Group A (Saline Group)

Placebo Comparator group

Description:

120 patients used 0.9% saline for nasal irrigation.

Treatment:

Other: 0.9% saline for nasal irrigation.

Group B (Fluticasone Propionate Nasal Spray)

Experimental group

Description:

120 patients received fluticasone propionate nasal spray.

Treatment:

Drug: Fluticasone propionate nasal spray.

Group C (Budesonide Nasal Irrigation)

Experimental group

Description:

120 patients received budesonide buffered with 0.9% isotonic saline.

Treatment:

Drug: Budesonide buffered with 0.9% isotonic saline.