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History of Changes for Study: NCT00641680
Rhinocort Aqua Versus Placebo and Fluticasone Propionate
Latest version (submitted January 21, 2011) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 21, 2008 None (earliest Version on record)
2 March 24, 2009 Study Status
3 January 21, 2011 Study Status
Comparison Format:

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Study NCT00641680
Submitted Date:  March 21, 2008 (v1)

Open or close this module Study Identification
Unique Protocol ID: D5360C00005
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
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2008
Overall Status: Completed
Study Start: April 2003
Primary Completion: July 2003 [Actual]
Study Completion: September 2003 [Actual]
First Submitted: March 18, 2008
First Submitted that
Met QC Criteria:
March 21, 2008
First Posted: March 24, 2008 [Estimate]
Last Update Submitted that
Met QC Criteria:
March 21, 2008
Last Update Posted: March 24, 2008 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: AstraZeneca
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Seasonal Allergic Rhinitis
Keywords: Seasonal allergic rhinitis
Nasal symptoms
Congestion
Rhinorrhea
Sneeze
budesonide
Rhinocort AQUA
Fluticasone propionate
Flonase
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: Double (masked roles unspecified)
Allocation: Randomized
Enrollment: 750 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: 1
Budesonide
Drug: Budesonide
Other Names:
  • Rhinocort AQUA
Active Comparator: 2
Fluticasone propionate
Drug: Fluticasone propionate
Other Names:
  • Flonase®
Placebo Comparator: 3 Drug: Placebo
Open or close this module 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:
2. To compare once daily treatment with Rhinocort against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.

[Time Frame: 2 weeks]
3. To compare once daily treatment with placebo against Fluticasone Propionate at reliving the nasal symptoms of seasonal allergic rhinitis.

[Time Frame: 2 weeks]
4. Safety assessment via adverse events and clinical measurements.

[Time Frame: 2 & 4 weeks]
Open or close this module Eligibility
Minimum Age: 12 Years
Maximum Age:
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Study Officials: Michael E Ruff, MD
Principal Investigator
Pharmaceutical Research, Dallas, USA
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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