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Assess the Efficacy and Safety of Rhinocort Aqua

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00641693
First received: March 18, 2008
Last updated: January 21, 2011
Last verified: January 2011
History of Changes

March 18, 2008
January 21, 2011
April 2004
May 2005   (final data collection date for primary outcome measure)
To compare Rhinocort with placebo to compare effects on nasal symptoms such as sneezing, runny and stuffy noses as assessed by caregivers. [ Time Frame: At 2 weeks ]
Same as current
Complete list of historical versions of study NCT00641693 on ClinicalTrials.gov Archive Site
  • Safety assessment via adverse events and clinical measurements [ Time Frame: At 1 & 2 weeks ]
  • To assess efficacy of Rhinocort via the physician and caregivers assessments [ Time Frame: At 2 weeks ]
Same as current
Not Provided
Not Provided
 
Assess the Efficacy and Safety of Rhinocort Aqua
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group, Phase II Study to Assess the Efficacy and Safety of RHINOCORT AQUA (Budesonide) Nasal Spray 16mg, 32mg and 64mg Per Day Versus Placebo in Paediatric Subjects Ages 2-5 Years Old With Allergic Rhinitis.

The purpose of this study is to compare Rhinocort with placebo in pediatric subjects aged 2-5 years with allergic rhinitis to study effects on nasal symptoms such as sneezing, runny and stuffy noses.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Allergic Rhinitis
  • Drug: Budesonide
    16mg Nasal Spray
    Other Name: Rhinocort AQUA
  • Drug: Budesonide
    32mg Nasal Spray
    Other Name: Rhinocort AQUA
  • Drug: Budesonide
    64mg Nasal Spray
    Other Name: Rhinocort AQUA
  • Drug: Placebo
  • Experimental: 1
    Nasal Spray
    Interventions:
    • Drug: Budesonide
    • Drug: Budesonide
    • Drug: Budesonide
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
650
May 2005
May 2005   (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 allergic rhinitis and a positive response to a skin prick test at Visit 1 or within the last 12 months for allergens that must be present in the subject's environment for the duration of the study.
  • At randomisation having nasal symptom scores as defined by the protocol.

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.
Both
2 Years to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00641693
D5360C00703, SD-005-0703
No
Not Provided
AstraZeneca
Not Provided
Study Director: Liza O'Dowd, MD AstraZeneca
Study Director: Bertil Andersson AstraZeneca
AstraZeneca
January 2011

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