New Nasal Applicator / New Formulation - User Study
This study has been completed.
Information provided by:
First received: March 18, 2008
Last updated: January 21, 2011
Last verified: January 2011
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).
Seasonal Allergic Rhinitis
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
||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).
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:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2002 (Final data collection date for primary outcome measure)
Other Name: Rhinocort AQUA
New type device
Other Name: Rhinocort Aqua
Placebo Comparator: 2
|Ages Eligible for Study:
||6 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
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: NCT00641979
||Shaile Shah, MD
||Allergy & Asthma Consultant, NJ, USA.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 18, 2008
||January 21, 2011
||United States: Food and Drug Administration
Keywords provided by AstraZeneca:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 31, 2015
Rhinitis, Allergic, Seasonal
Immune System Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents