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Rhinocort Aqua Versus Placebo and Fluticasone Propionate

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ClinicalTrials.gov Identifier: NCT00641680
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: Budesonide Drug: Fluticasone propionate Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : April 2003
Primary Completion Date : July 2003
Study Completion Date : July 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
Budesonide
Drug: Budesonide
Other Name: Rhinocort AQUA
Active Comparator: 2
Fluticasone propionate
Drug: Fluticasone propionate
Other Name: Flonase®
Placebo Comparator: 3 Drug: Placebo


Outcome Measures

Primary Outcome Measures :
  1. To compare once daily treatment with Rhinocort against placebo and at reliving the nasal symptoms of seasonal allergic rhinitis. [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. To compare once daily treatment with Rhinocort against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis. [ Time Frame: 2 weeks ]
  2. To compare once daily treatment with placebo against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis. [ Time Frame: 2 weeks ]
  3. Safety assessment via adverse events and clinical measurements. [ Time Frame: 2 & 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00641680


Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Michael E Ruff, MD Pharmaceutical Research, Dallas, USA
More Information

ClinicalTrials.gov Identifier: NCT00641680     History of Changes
Other Study ID Numbers: D5360C00005
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Seasonal allergic rhinitis
Nasal symptoms
Congestion
Rhinorrhea
Sneeze
budesonide
Rhinocort AQUA
Fluticasone propionate
Flonase

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Budesonide
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists