NCT00641680

Brief Summary

The purpose of this study is to compare once daily treatment with Rhinocort against placebo and Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2003

Shorter than P25 for phase_3

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, 2003

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
4.7 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

3 months

First QC Date

March 18, 2008

Last Update Submit

January 21, 2011

Conditions

Seasonal Allergic Rhinitis

Keywords

Seasonal allergic rhinitisNasal symptomsCongestionRhinorrheaSneezebudesonideRhinocort AQUAFluticasone propionateFlonase

Outcome Measures

Primary Outcomes (1)

  • To compare once daily treatment with Rhinocort against placebo and at reliving the nasal symptoms of seasonal allergic rhinitis.

    2 weeks

Secondary Outcomes (3)

  • To compare once daily treatment with Rhinocort against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.

    2 weeks

  • To compare once daily treatment with placebo against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.

    2 weeks

  • Safety assessment via adverse events and clinical measurements.

    2 & 4 weeks

Study Arms (3)

1

EXPERIMENTAL

Budesonide

Drug: Budesonide

2

ACTIVE COMPARATOR

Fluticasone propionate

Drug: Fluticasone propionate

3

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BudesonideDRUG
Also known as: Rhinocort AQUA
1
Fluticasone propionateDRUG
Also known as: Flonase®
2
PlaceboDRUG
3

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • At least a 2 year documented history of seasonal allergic rhinitis
  • who, 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 positive response to a skin prick test at Visit 1 or within the last 12 months for grass allergens that must be present in the subject's environment for the duration of 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 specifies in the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rhinitis, Allergic, SeasonalRhinorrheaSneezing

Interventions

BudesonideFluticasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsAndrostadienesAndrostenesAndrostanes

Study Officials

  • Michael E Ruff, MD

    Pharmaceutical Research, Dallas, USA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
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, 2003

Primary Completion

July 1, 2003

Study Completion

July 1, 2003

Last Updated

January 24, 2011

Record last verified: 2011-01