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New Nasal Applicator / New Formulation - User Study
This study has been completed.
Study NCT00641979   Information provided by AstraZeneca
First Received: March 18, 2008   Last Updated: March 24, 2009   History of Changes

March 18, 2008
March 24, 2009
April 2002
August 2002   (final data collection date for primary outcome measure)
Assessment of Total Nasal Symptom scores (Rhinorrhea, Congestion, Itching & Sneezing) [ Time Frame: 2 weekly ]
Same as current
Complete list of historical versions of study NCT00641979 on ClinicalTrials.gov Archive Site
  • Durability of device [ Time Frame: End of study ]
  • Safety assessment via adverse events and clinical measurements [ Time Frame: 2 weekly ]
Same as current
 
New Nasal Applicator / New Formulation - User Study
A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Functionality of a New Nasal Device With Reformulated Rhinocort Aqua (Budesonide) Versus the Current Product and Versus Placebo in Subjects With Seasonal Allergic Rhinitis (SAR).

The purpose of this study is to compare the efficacy of once daily dosing with Rhinocort Aqua (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the symptoms of seasonal allergic rhinitis (SAR).

 
Phase III
Interventional
Allocation:  Randomized
Endpoint Classification:  Safety/Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Double-Blind
Primary Purpose:  Treatment
Seasonal Allergic Rhinitis
  • Drug: budesonide
    Current product
    Other Name: Rhinocort AQUA
  • Device: Budesonide
    New type device
    Other Name: Rhinocort Aqua
  • Drug: Placebo
  • 1: Experimental
    Rhinocort
    Interventions:
    • Drug: budesonide
    • Device: Budesonide
  • 2: Placebo Comparator
    Intervention: Drug: Placebo
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
200
August 2002
August 2002   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 documented history of at least one year of seasonal allergic rhinitis.
  • A positive response to a skin prick test for grass allergens that must be present in the subject's environment throughout 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 specified in the protocol.
Both
6 Years and older
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00641979
 
SD-005-0698, D5360C00698
AstraZeneca
 
Principal Investigator: Shaile Shah, MD Allergy & Asthma Consultant, NJ, USA.
Study Director: Bertil Andersson AstraZeneca
AstraZeneca
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP