NCT00641979

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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2002

Shorter than P25 for phase_2

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

April 1, 2002

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2002

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

Enrollment Period

4 months

First QC Date

March 18, 2008

Last Update Submit

January 21, 2011

Conditions

Seasonal Allergic Rhinitis

Keywords

Allergic rhinitisNasal symptomsCongestionRhinorrheaSneezebudesonideRhinocort AQUA

Outcome Measures

Primary Outcomes (1)

  • Assessment of Total Nasal Symptom scores (Rhinorrhea, Congestion, Itching & Sneezing)

    2 weekly

Secondary Outcomes (2)

  • Durability of device

    End of study

  • Safety assessment via adverse events and clinical measurements

    2 weekly

Study Arms (2)

1

EXPERIMENTAL

Rhinocort

Drug: budesonideDevice: Budesonide

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BudesonideDRUG

Current product

Also known as: Rhinocort AQUA
1
PlaceboDRUG
2

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rhinitis, Allergic, SeasonalRhinitis, AllergicRhinorrheaSneezing

Interventions

Budesonide

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Shaile Shah, MD

    Allergy & Asthma Consultant, NJ, USA.

    PRINCIPAL INVESTIGATOR

  • Bertil Andersson

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 18, 2008

First Posted

March 24, 2008

Study Start

April 1, 2002

Primary Completion

August 1, 2002

Study Completion

August 1, 2002

Last Updated

January 24, 2011

Record last verified: 2011-01