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New Nasal Applicator / New Formulation - User Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00641979
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : January 24, 2011
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: budesonide Device: Budesonide Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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).
Study Start Date : April 2002
Actual Primary Completion Date : August 2002
Actual Study Completion Date : August 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever
Drug Information available for: Budesonide

Arm Intervention/treatment
Experimental: 1
Drug: budesonide
Current product
Other Name: Rhinocort AQUA

Device: Budesonide
New type device
Other Name: Rhinocort Aqua

Placebo Comparator: 2 Drug: Placebo

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00641979

Sponsors and Collaborators
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Principal Investigator: Shaile Shah, MD Allergy & Asthma Consultant, NJ, USA.
Study Director: Bertil Andersson AstraZeneca
Layout table for additonal information Identifier: NCT00641979    
Other Study ID Numbers: SD-005-0698
First Posted: March 24, 2008    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011
Keywords provided by AstraZeneca:
Allergic rhinitis
Nasal symptoms
Rhinocort AQUA
Additional relevant MeSH terms:
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Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Respiratory Tract Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists