NCT06858423

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 5, 2025

Completed
Last Updated

March 5, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

February 14, 2025

Last Update Submit

February 27, 2025

Conditions

Nasal Allergy

Keywords

allergic rhinitisBudesonideluticasone propionate

Outcome Measures

Primary Outcomes (1)

  • Clinical improvement

    improvement measured by pre- and post-treatment SNOT score

    1 month

Secondary Outcomes (1)

  • Endoscopic examination improvement

    1 month

Other Outcomes (1)

  • Effects on serum cortisol level

    1 month

Study Arms (3)

Group A (Saline Group)

PLACEBO COMPARATOR

120 patients used 0.9% saline for nasal irrigation.

Other: 0.9% saline for nasal irrigation.

Group B (Fluticasone Propionate Nasal Spray)

EXPERIMENTAL

120 patients received fluticasone propionate nasal spray.

Drug: Fluticasone propionate nasal spray.

Group C (Budesonide Nasal Irrigation)

EXPERIMENTAL

120 patients received budesonide buffered with 0.9% isotonic saline.

Drug: Budesonide buffered with 0.9% isotonic saline.

Interventions

Budesonide buffered with 0.9% isotonic saline.DRUG

120 patients received budesonide buffered with 0.9% isotonic saline.

Group C (Budesonide Nasal Irrigation)
Fluticasone propionate nasal spray.DRUG

120 patients received fluticasone propionate nasal spray.

Group B (Fluticasone Propionate Nasal Spray)
0.9% saline for nasal irrigation.OTHER

120 patients used 0.9% saline for nasal irrigation.

Group A (Saline Group)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Benha University Hospitals - Otolaryngology department

Banhā, Qalyobia, 6460001, Egypt

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Sodium ChlorideNasal Lavage

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsTherapeutic IrrigationInvestigative Techniques

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer and consultant of otolaryngology

Study Record Dates

First Submitted

February 14, 2025

First Posted

March 5, 2025

Study Start

August 15, 2023

Primary Completion

March 31, 2024

Study Completion

May 31, 2024

Last Updated

March 5, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)