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Rhinocort Aqua Versus Placebo and Fluticasone Propionate

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Seasonal Allergic Rhinitis

Intervention: Budesonide (Drug); Fluticasone propionate (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Michael E Ruff, MD, Principal Investigator, Affiliation: Pharmaceutical Research, Dallas, USA

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.

Clinical Details

Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-group, Phase IIIb Study to Assess the Efficacy, Safety & Product Attributes of Rhinocort Aqua(Budesonide) Versus Placebo and FluticasonePropionate as an Active Comparator in Patients 12yrs Age &Older With SeasonalAllergicRhinitis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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

Secondary outcome:

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

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

Safety assessment via adverse events and clinical measurements.

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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. 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 specifies in the protocol.

Locations and Contacts

Additional Information

Starting date: April 2003
Last updated: January 21, 2011

Page last updated: August 23, 2015

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