- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00641680
Rhinocort Aqua Versus Placebo and Fluticasone Propionate
January 21, 2011 updated by: AstraZeneca
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
750
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 3
|
|
Experimental: 1
Budesonide
|
Other Names:
|
Active Comparator: 2
Fluticasone propionate
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare once daily treatment with Rhinocort against placebo and at reliving the nasal symptoms of seasonal allergic rhinitis.
Time Frame: 2 weeks
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare once daily treatment with Rhinocort against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.
Time Frame: 2 weeks
|
2 weeks
|
To compare once daily treatment with placebo against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.
Time Frame: 2 weeks
|
2 weeks
|
Safety assessment via adverse events and clinical measurements.
Time Frame: 2 & 4 weeks
|
2 & 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michael E Ruff, MD, Pharmaceutical Research, Dallas, USA
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Primary Completion (Actual)
July 1, 2003
Study Completion (Actual)
July 1, 2003
Study Registration Dates
First Submitted
March 18, 2008
First Submitted That Met QC Criteria
March 21, 2008
First Posted (Estimate)
March 24, 2008
Study Record Updates
Last Update Posted (Estimate)
January 24, 2011
Last Update Submitted That Met QC Criteria
January 21, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Seasonal
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Budesonide
- Fluticasone
- Xhance
Other Study ID Numbers
- D5360C00005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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