Efficacy and Safety of S0597 Nasal Spray in Hay Fever Provoqued in a Room with Pollen Atmosphere

Conditions: Seasonal allergic rhinitis
MedDRA version: 14.1Level: PTClassification code 10039095Term: Rhinitis seasonalSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2012-001613-16-DE

Lead Sponsor: Sun Pharma Advanced Research Company Ltd. (SPARC)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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 <10 pack years.
Pack years = (Number cigarettes smoked per day /20) x number of years smoked.
7.Women will be considered for inclusion if they are:Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal, with documented proof of hysterectomy or tubal ligation, or meet clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit)
OR
Of child-bearing potential and are practicing an acceptable method of birth control. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence, double barrier method and vasectomised partner.
8.In the opinion of the investigator, patients must be, able to understand and willing to sign the Informed Consent Form (ICF)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 155
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

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.