MULTICENTER, RANDOMIZED, DOUBLE BLIND, CONTROLLED, CLINICAL STUDY TO DEMONSTRATE THE THERAPEUTIC CLINICAL EQUIVALENCE OF TWO MOMETASONE NASAL SPRAYS IN THE RELIEF OF THE SIGNS AND SYMPTOMS OF SEASONAL ALLERGIC RHINITIS

• Conditions: SEASONAL ALLERGIC RHINITIS; MedDRA version: 14.1Level: LLTClassification code 10039776Term: Seasonal allergic rhinitisSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-001318-14-BG
• Lead Sponsor: PH&T SpA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-28
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

•Male and female, 12 years until 65 years old.
•Subjects with a minimum of 2 years history of seasonal allergic rhinitis
•Documented positive allergy skin test, either intradermal or epicutaneous, and or validated IgE (RAST, Western Blot, ELISA)*
•Seasonal allergic rhinitis symptoms present at the time of the study randomization: a TNSS score of at least 6 up to a maximum score of 12 at the day of randomization visit.
•Subjects capable of recording seasonal nasal allergy symptoms throughout a diary to be filled-in every day for all study duration.
•Subjects able to provide written inform consent. For Subjects under the age of majority the parent or legal guardian should sign the consent form and the child will be required to sign a Subject assent form.

Are the trial subjects under 18? yes
Number of subjects for this age range: 35
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 315
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Females pregnant, lactating or planning to get pregnant during the study.
•Non seasonal allergic rhinitis
•Clinically significant nasal disease (other than SAR) or nasal surgery or significant nasal structural abnormalities
•Bacterial or viral infection of the upper or lower respiratory tract ,nasal sinus or middle ear within the previous 30 days.
•Presence of a significant pulmonary disease including asthma requiring use of controller medication
•Subject previously treated with mometasone within the previous 30 days
•Subject who have received anti-allergy immunotherapy (desensitising subjects with increase of allergen challenges) in the previous 2 years or are still receiving this kind of therapy.
•Subject with a history of tuberculosis.
•Subject with glaucoma, cataracts, ocular herpes simplex, conjunctivitis or other eye infection.
•Subject with a recent exposure (30 days) or at risk of being exposed to chicken pox or measles.
•Use of concomitant medication(s) that could affect the assessment of efficacy and safety of study treatment
•Any known hypersensitivity to mometasone, other steroids or any of the components of the study nasal spray.
•Subjects with a history of alcohol or drug abuse.
•Congenital or acquired severe immunodeficiency or know immunodeficiency virus (HIV) infection
•Significant psychiatric disease that in the Investigator would affect subject safety or influence study outcome

Study & Design

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