We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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.
ClinicalTrials.gov Identifier: NCT00641979
Recruitment Status : Completed
First Posted : March 24, 2008
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:

Study Description
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

Study Design

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
Primary Completion Date : August 2002
Study Completion Date : August 2002

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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 ]

Eligibility Criteria

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.


Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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

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 ClinicalTrials.gov identifier (NCT number): NCT00641979


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

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

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