Back to resultsRhinocort Aqua Versus Placebo and Fluticasone Propionate
Primary Purpose
Seasonal Allergic Rhinitis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Budesonide
Fluticasone propionate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring Seasonal allergic rhinitis, Nasal symptoms, Congestion, Rhinorrhea, Sneeze, budesonide, Rhinocort AQUA, Fluticasone propionate, Flonase
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
1
2
3
Arm Description
Budesonide
Fluticasone propionate
Outcomes
Primary Outcome Measures
To compare once daily treatment with Rhinocort against placebo and at reliving the nasal symptoms of seasonal allergic rhinitis.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00641680
Brief Title
Rhinocort Aqua Versus Placebo and Fluticasone Propionate
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 Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
July 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
Keywords
Seasonal allergic rhinitis, Nasal symptoms, Congestion, Rhinorrhea, Sneeze, budesonide, Rhinocort AQUA, Fluticasone propionate, Flonase
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
750 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Budesonide
Arm Title
2
Arm Type
Active Comparator
Arm Description
Fluticasone propionate
Arm Title
3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Budesonide
Other Intervention Name(s)
Rhinocort AQUA
Intervention Type
Drug
Intervention Name(s)
Fluticasone propionate
Other Intervention Name(s)
Flonase®
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To compare once daily treatment with Rhinocort against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.
Time Frame
2 weeks
Title
To compare once daily treatment with placebo against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.
Time Frame
2 weeks
Title
Safety assessment via adverse events and clinical measurements.
Time Frame
2 & 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael E Ruff, MD
Organizational Affiliation
Pharmaceutical Research, Dallas, USA
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Rhinocort Aqua Versus Placebo and Fluticasone Propionate
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