Seasonal allergic rhinitis MedDRA version: 14.1 Level: PT Classification code 10039095 Term: Rhinitis seasonal System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Code: S0597 0.05%
Pharmaceutical Form: Nasal spray, suspension
Current Sponsor code: S0597
Other descriptive name: S0597
Concentration unit: % (W/W) percent weight/weight
Concentration type: e
Sponsors
Sun Pharma Advanced Research Company Ltd. (SPARC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or female patients aged 18 to 65 years (inclusive) 2.History of seasonal allergic rhinitis 3.Positive skin prick test to Dactylis glomerata within 12 months prior to or on Visit 1 4.Total Nasal Symptom Score of =6 at least once during the 2h-screening EEC exposure 5.Forced Expiratory Volume in one second (FEV1) =80 % predicted at screening 6.A non-smoker for at least the past 12 months with a pack history of =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1.History or presence of perennial allergic rhinitis 2.Upper or lower respiratory tract infection 2 weeks before Visit 2 3.Significant pulmonary disease other than allergic rhinitis or mild asthma controlled by beta-2-agonists alone 4.History of cataract, glaucoma or ocular hypertension 5.Immunizations or vaccinations within 4 weeks prior to Visit 1 6.Anti-allergy immunotherapy (desensitizing with allergens) within two years prior to Visit 1 7.Presence of clinically significant polyposis nasi 8.Anatomical deviations of the nasal septum that significantly impair ventilation or airflow 9.Received treatment with systemic, topical, nasal or inhalative corticosteroids within the last 4 weeks prior to Visit 1 10.Received treatment with oral H1-Antihistamines or cromoglycates or leukotriene modifiers or topical decongestants within 72 hrs before Visit 1 11.Received treatment with medication that might interfere with rescue medication for allergic shock (e.g. beta blocker) within the one weeks prior to Visit 1 12.Pregnant or nursing women 13.Malignant growth (actual, condition after carcinoma not longer than 5 years without relapse) 14.History of alcohol (male > 28 units of alcohol per week, female > 21 units per week. One unit of alcohol is defined as a medium (125 ml) glass of wine, half a pint (250 ml) of beer or one measure (24 ml) of spirits)or drug abuse (amphetamines, cocaine or phencyclidine) 15.Positive serology for an infectious disease (including hepatitis B or C) at screening and known case of human immunodeficiency virus (HIV) 16.Parallel participation in another study, participation in a study within less than 30 days prior to study entry, or previous participation in this same study 17.Any clinically significant local or systemic, acute or chronic medical conditions or laboratory finding, which, at discretion of the Investigator, would preclude application of the study medication and/or influence the outcome of the study and/or affect safety and/or participation of the patient in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess efficacy and safety of intranasal S0597 compared to placebo in alleviating the signs and symptoms of seasonal allergic rhinitis in environmental Exposure chamber (EEC) model after 2 weeks of treatment;Secondary Objective: Safety of intranasal S0597;Primary end point(s): Change in TNSS (Total Nasal Symptom Score) in a 4-hour environmental challenge with Dactylis glomerate pollen in an EEC from baseline to Day 15/16.;Timepoint(s) of evaluation of this end point: Baseline (day 1)/day 15/16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change in TNSS subscales in a 4-hour environmental challenge with Dactylis glomerate pollen in an EEC from baseline to Day 15/16 Change in the amount of nasal secretion in grams in a 4-hour environmental challenge with Dactylis glomerate pollen in an EEC from baseline to Day 15/16 Incidence of treatment-emergent adverse events;Timepoint(s) of evaluation of this end point: Baseline (day 1)/day 15/16 | — |
Countries
Germany
Contacts
Public ContactClinical Operations
SIRO Clinpharm Germany GmbH
Outcome results
None listed