Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Treatment of Seasonal Allergic Rhinitis (Study P05106).

• Conditions: Seasonal Allergic Rhinitis; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-004916-12-Outside-EU/EEA
• Lead Sponsor: Schering-Plough Research Institute, a Division of Schering Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-24
• Last Update Posted: 7 September 2015

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. A subject must have been 12 years of age or older, of either sex, and of any race.
2. A subject must have had at least a 2-year documented history of SAR which exacerbated during the study season.
3. A subject must have had a positive skin prick test response to an appropriate seasonal allergen at the Screening Visit. IgE-mediated hypersensitivity to an appropriate seasonal allergen (ie, prevailing trees
and/or grasses) must have been documented by a positive response to the skin prick test with wheal diameter at least 3 mm larger than diluent control after 20 minutes.
4. A subject must have been clinically symptomatic at the Screening Visit (assessed by the subject): nasal rhinorrhea must have been =2, nasal congestion must have been =2, TNSS must have been =6, TOSS must have been =4, and an overall evaluation of SAR must have been =2.
5. A subject must have been clinically symptomatic at the Baseline Visit. The total of the seven run-in diary reflective (PRIOR) scores for the 3 days prior to Baseline and the AM of the Baseline Visit must have been: rhinorrhea score =14, nasal congestion score =14, TNSS =42, and TOSS =28.
6. A subject must have been in general good health as confirmed by routine clinical and laboratory testing. All laboratory tests must have been within normal limits or clinically acceptable to the investigator and sponsor
7. A subject must have been free of any clinically significant disease, other than SAR, which would have interfered with the study evaluations.
8. A subject and/or parent/guardian must have been willing to give written informed consent and must have been able to adhere to dosing and visit schedules and met study requirements.
9. A female subject of childbearing potential must have had a negative serum pregnancy test (HCG) at Screening. Nonsterile and premenopausal female subjects must have been using a medically acceptable method of birth control, ie, double barrier method, oral contraceptive, hormonal implant, or depot injectable prior to Screening and during the study.

Are the trial subjects under 18? yes
Number of subjects for this age range: 56
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 365
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

1. A subject whose ability to provide informed consent was compromised.
2. A subject with a history of noncompliance with medications or treatment protocols.
3. A subject with a history of anaphylaxis and/or other severe local reaction(s) to skin testing.
4. A subject with significant medical condition(s) that, in the judgment of the investigator, might have interferedwith the study or required treatment.
5. A subject who 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 had a viral upper respiratory infection within
7 days prior to the Screening Visit.
6. A subject who had used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
7. Pregnant or nursing females.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified