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New Nasal Applicator / New Formulation - User Study

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00641979
First received: March 18, 2008
Last updated: January 21, 2011
Last verified: January 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Seasonal Allergic Rhinitis
 Drug: budesonide
Device: 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 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).

Resource links provided by NLM:

MedlinePlus related topics: Hay Fever
Drug Information available for: Budesonide
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Assessment of Total Nasal Symptom scores (Rhinorrhea, Congestion, Itching & Sneezing) [ Time Frame: 2 weekly ]

Secondary Outcome Measures:
  • Durability of device [ Time Frame: End of study ]
  • Safety assessment via adverse events and clinical measurements [ Time Frame: 2 weekly ]

Estimated Enrollment: 200
Study Start Date: April 2002
Study Completion Date: August 2002
Primary Completion Date: August 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Rhinocort
 Drug: budesonide
Current product
Other Name: Rhinocort AQUA
Device: Budesonide
New type device
Other Name: Rhinocort Aqua
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   6 Years and older
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00641979

Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Shaile Shah, MD Allergy & Asthma Consultant, NJ, USA.
Study Director: Bertil Andersson AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00641979     History of Changes
Other Study ID Numbers: SD-005-0698, D5360C00698
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
Nasal symptoms
Congestion
Rhinorrhea
 Sneeze
budesonide
Rhinocort AQUA

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

ClinicalTrials.gov processed this record on May 23, 2013