SEASONAL ALLERGIC RHINITIS MedDRA version: 14.1 Level: LLT Classification code 10039776 Term: Seasonal allergic rhinitis System Organ Class: 100000004855
Conditions
Interventions
Product Name: Mometasone Furoate nasal spray
Pharmaceutical Form: Nasal spray, suspension
INN or Proposed INN: mometasone furoate monohydrated
CAS Number: 141646-00-6
Current Sponsor code: N/A
Concent
Sponsors
PH&T SpA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary efficacy evaluation is to demonstrate the therapeutic clinical equivalence among a generic mometasone product and the Nasonex Nasal Spray through evaluation of TNSS PM .;Timepoint(s) of evaluation of this end point: After 2 weeks of treatment;Main Objective: The primary objective of this multicenter, randomized, double blind, controlled, clinical study is to demonstrate the therapeutic clinical equivalence of two mometasone nasal sprays in the relief of the signs and symptoms of seasonal allergic rhinitis, in term of change from baseline in average instantaneous PM Total Nasal Symptom Scores (TNSS the sum of individual symptom scores) recorded in subject’s diary. ;Secondary Objective: Efficacy monitoring in term of assessment of evolution during the study treatments of AM total nasal symptoms score , AM total non nasal symptoms score and PM total non nasal symptoms score recorded in subject’s diary . Overall Subject’s and Physician’s global assessment. Clinical Global Improvement (CGI) evaluation Quality of life evaluation (RQLQ) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: Evaluation of TNSS AM and TNNSS AM and PM; The patient’s Global Assessment for Efficacy and Safety and the investigator’s Global Assessment for Efficacy and Safety Clinical Global Improvement (CGI) evaluation. Quality of life (QoL) evaluation (only for adult subjects) ;Timepoint(s) of evaluation of this end point: After 2 weeks of treatment | — |
Countries
Bulgaria, Romania
Contacts
Public ContactElisabetta Pieri
Phidea Group Srl a socio unico
Outcome results
None listed