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Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05528)(COMPLETED)

Primary Purpose

Allergic Rhinitis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Mometasone furoate nasal spray (MFNS)

Matching placebo nasal spray

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

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

Inclusion Criteria:

A subject must be 12 years of age or older, of either sex, and of any race.
A subject must have at least a 2-year history of SAR which exacerbates during the study season.
A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1.
A subject must be clinically symptomatic at the Screening and Baseline Visits.

Exclusion Criteria:

A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit.
A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
A subject who is participating in any other clinical study.
A subject who is part of the staff personnel directly involved with this study.
A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.
A female subject who is breast-feeding, pregnant, or intends to become pregnant.
A subject previously randomized into this study.
A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm Description

Mometasone furoate nasal spray 200 mcg QD (once per day)

Matching placebo nasal spray

Outcomes

Primary Outcome Measures

The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days.

Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective])

Secondary Outcome Measures

The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days

Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12.

Full Information

NCT ID

NCT00733005

First Posted

August 8, 2008

Last Updated

February 7, 2022

Sponsor

Organon and Co

1. Study Identification

Unique Protocol Identification Number

NCT00733005

Brief Title

Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05528)(COMPLETED)

Official Title

Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Organon and Co

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.

6. Conditions and Keywords

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

Allergic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

324 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Arm Description

Mometasone furoate nasal spray 200 mcg QD (once per day)

Arm Title

Arm 2

Arm Type

Placebo Comparator

Arm Description

Matching placebo nasal spray

Intervention Type

Drug

Intervention Name(s)

Mometasone furoate nasal spray (MFNS)

Other Intervention Name(s)

Nasonex Nasal Spray

Intervention Description

MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days

Intervention Type

Drug

Intervention Name(s)

Matching placebo nasal spray

Other Intervention Name(s)

Placebo

Intervention Description

Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days

Primary Outcome Measure Information:

Title

The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days.

Description

Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective])

Time Frame

15 days of treatment

Secondary Outcome Measure Information:

Title

The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days

Description

Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12.

Time Frame

15 days of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A subject must be 12 years of age or older, of either sex, and of any race. A subject must have at least a 2-year history of SAR which exacerbates during the study season. A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1. A subject must be clinically symptomatic at the Screening and Baseline Visits. Exclusion Criteria: A subject with a history of severe local reaction(s) or anaphylaxis to skin testing. A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit. A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit. A subject who is participating in any other clinical study. A subject who is part of the staff personnel directly involved with this study. A subject who is a family member (parent, spouse, or sibling) of the investigational study staff. A female subject who is breast-feeding, pregnant, or intends to become pregnant. A subject previously randomized into this study. A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Learn more about this trial

Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05528)(COMPLETED)

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