Study of Mometasone Furoate Nasal Spray and Oxymetazoline Nasal Spray Given Together Once A Day To Treat Seasonal Allergic Rhinitis (P04500)

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

• Registration Number: EUCTR2014-004924-23-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: 875

Inclusion Criteria

1. A subject must be 12 years of age or older, of either sex, and of any race.
2. A subject must have at least a 2-year documented history of SAR which exacerbates during the time period over which the subject will be participating.
3. At screening (Visit 1), a subject must have a documented positive skin-prick test response to an appropriate seasonal allergen appropriate to the geographical vicinity in which the study is being carried out and over the period of time the subject is participating. Immunoglobulin E (IgE)-mediated
hypersensitivity to a seasonal allergen (eg, prevailing trees and/or grasses) must be 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 be clinically symptomatic at the Screening Visit based upon NOW (instantaneous) allergy signs/symptom scores: nasal rhinorrhea must be =2, nasal congestion must be =2, and TNSS must be =6 (see Section 7.6 for details).
5. A subject must be clinically symptomatic at the Baseline Visit based upon NOW (instantaneous) allergy signs/symptom scores. For the 3 calendar days immediately before the Baseline Visit, the 7 twice-daily (AM plus PM, plus AM of the Baseline Visit) run-in diary NOW rhinorrhea score must be =14, nasal
congestion score must be =14, and TNSS must total =42.
6. A subject must be in general good health as confirmed by routine clinical and laboratory testing and ECG results. Clinical laboratory tests (complete blood count [CBC], blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator and the sponsor.
7. A subject must be free of any clinically significant disease, other than SAR, which would interfere with the study evaluations.
8. A subject and/or a parent/guardian must be willing to give written informed consent and must be able to adhere to dosing and visit schedules and study requirements.
9. A female subject of child-bearing potential must have a negative serum pregnancy test (beta-human chorionic gonadotropin [ß-hCG]) at screening. Nonsterile and premenopausal female subjects must be using a medically acceptable method of birth control, ie, double barrier method (eg, condom with spermicide), oral contraceptive, hormonal implant, medically prescribed intrauterine device (IUD), or depot injectable prior to screening and during the entire study.
10. A subject has the ability to transmit electronic diary data on a regular basis.
Are the trial subjects under 18? yes
Number of subjects for this age range: 42
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 649
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14

Exclusion Criteria

1. A subject with a history of anaphylaxis and/or other severe local reaction(s) to skin testing.
2. A subject with asthma who require chronic use of inhaled or systemic corticosteroids.
3. A subject with current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
4. A subject with rhinitis medicamentosa.
5. A subject with glaucoma and/or increased intraocular pressure.
6. A subject who received a monoamine oxidase (MAO) inhibitor, ß-blocker or tricyclic antidepressants with 14 days of the Screening Visit.
7. A subject with a history of allergies to more than 2 classes of medications or who are allergic to or cannot tolerate nasal sprays.
8. 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 before the Screening Visit.
9. A subject who has nasal structural abnormalities, including large nasal polyps and marked septal deviations, which significantly interfere with nasal air flow.
10. A subject who, in the opinion of the investigator, is dependent on nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids.
11. A subject who has used any drug in an investigational protocol in the 30 days before the Screening Visit.
12. A subject on immunotherapy (desensitization therapy), unless the subject is on a regular maintenance schedule prior to the Screening Visit and will stay on this schedule for the remainder of the study. A subject may not receive desensitization treatment within 24 hours before any visit.
13. A pregnant or nursing female.
14. A family member of the investigation study staff.
15. Members of the same family living in the same household.
16. A subject with current evidence of clinically significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, pulmonary, autoimmune disease, or other disease that precludes the subject’s participation in the study. Particular attention should be given to exclude subjects with conditions that
would currently interfere with the absorption, distribution, metabolism, or excretion of the study drug or interfere with the subject’s ability to complete or reliably complete the diaries.
17. A subject with significant medical condition(s) that, in the judgment of the investigator, might interfere with the study or require treatment (including eg, uncontrolled hypertension or diabetes).
18. A subject whose ability to provide informed consent (or, in the case of subjects less than the age of majority in their jurisdiction, their parent’s consent and their assent) is compromised.
19. A subject with a history of noncompliance with medications or treatment protocols.

Study & Design

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