EUCTR2012-001613-16-DEActive, not recruitingNot Applicable
Efficacy And Safety of Intranasal S0597 in Environmental Exposure Chamber Model of Seasonal Allergic Rhinitis: A Phase II, Single-Center, Randomized, Double-Blind, Placebo-Controlled Parallel Group Study
Sun Pharma Advanced Research Company Ltd. (SPARC)0 sitesStarted: April 30, 2012Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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)
- •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.
Investigators
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