Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention Phase
Allergic Rhinitis
Drug: Budesonide
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 650
Study Start Date: April 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Nasal Spray
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
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641693

Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Liza O'Dowd, MD AstraZeneca
Study Director: Bertil Andersson AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00641693     History of Changes
Other Study ID Numbers: D5360C00703, SD-005-0703
Study First Received: March 18, 2008
Last Updated: January 21, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Allergic rhinitis
Paediatric
Nasal symptoms
Congestion
Rhinorrhea
Sneeze
budesonide
Rhinocort AQUA

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Budesonide
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014