New Nasal Applicator / New Formulation - User Study

A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Functionality of a New Nasal Device With Reformulated Rhinocort Aqua (Budesonide) Versus the Current Product and Versus Placebo in Subjects With Seasonal Allergic Rhinitis (SAR).

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00641979

Enrollment

200

Registered

2008-03-24

Start date

2002-04-30

Completion date

2002-08-31

Last updated

2011-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal Allergic Rhinitis

Keywords

Allergic rhinitis, Nasal symptoms, Congestion, Rhinorrhea, Sneeze, budesonide, Rhinocort AQUA

Brief summary

The purpose of this study is to compare the efficacy of once daily dosing with Rhinocort Aqua (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the symptoms of seasonal allergic rhinitis (SAR).

Interventions

DRUGbudesonide

Current product

DEVICEBudesonide

New type device

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

Inclusion criteria

* In the opinion of the investigator, is a candidate for treatment with nasal steroids based on a history of either a) inadequate control of symptoms with antihistamines, decongestants and/or immunotherapy, or b) prior successful treatment with nasal steroids. * A documented history of at least one year of seasonal allergic rhinitis. * A positive response to a skin prick test for grass allergens that must be present in the subject's environment throughout the study.

Exclusion criteria

* Primary or secondary adrenal insufficiency * Nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator. * A diagnosis of asthma requiring treatment as specified in the protocol.

Design outcomes

Primary

Measure	Time frame
Assessment of Total Nasal Symptom scores (Rhinorrhea, Congestion, Itching & Sneezing)	2 weekly

Secondary

Measure	Time frame
Durability of device	End of study
Safety assessment via adverse events and clinical measurements	2 weekly

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026