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New Nasal Applicator / New Formulation - User Study

Primary Purpose

Seasonal Allergic Rhinitis

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

budesonide

Budesonide

Placebo

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring Allergic rhinitis, Nasal symptoms, Congestion, Rhinorrhea, Sneeze, budesonide, Rhinocort AQUA

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Rhinocort

Outcomes

Primary Outcome Measures

Assessment of Total Nasal Symptom scores (Rhinorrhea, Congestion, Itching & Sneezing)

Secondary Outcome Measures

Durability of device

Safety assessment via adverse events and clinical measurements

Full Information

NCT ID

NCT00641979

First Posted

March 18, 2008

Last Updated

January 21, 2011

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00641979

Brief Title

New Nasal Applicator / New Formulation - User Study

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 Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

April 2002 (undefined)

Primary Completion Date

August 2002 (Actual)

Study Completion Date

August 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Seasonal Allergic Rhinitis

Keywords

Allergic rhinitis, Nasal symptoms, Congestion, Rhinorrhea, Sneeze, budesonide, Rhinocort AQUA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Rhinocort

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

budesonide

Other Intervention Name(s)

Rhinocort AQUA

Intervention Description

Current product

Intervention Type

Device

Intervention Name(s)

Budesonide

Other Intervention Name(s)

Rhinocort Aqua

Intervention Description

New type device

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Assessment of Total Nasal Symptom scores (Rhinorrhea, Congestion, Itching & Sneezing)

Time Frame

2 weekly

Secondary Outcome Measure Information:

Title

Durability of device

Time Frame

End of study

Title

Safety assessment via adverse events and clinical measurements

Time Frame

2 weekly

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shaile Shah, MD

Organizational Affiliation

Allergy & Asthma Consultant, NJ, USA.

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Bertil Andersson

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

New Nasal Applicator / New Formulation - User Study

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