Health Condition 1: J308- Other allergic rhinitis
Conditions
Interventions
Intervention1: Fluticasone
Furoate and Oxymetazoline Hydrochloride
Nasal Spray 27.5 / 50 mcg: Patients will be asked to take 2 sprays of the investigational product (nasal spray) in
each nostril once
Sponsors
Cadila Healthcare Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex 18 to 65 years of age (both inclusive) 2. Patient with a documented clinical history of Seasonal Allergic Rhinitis with exacerbations during the study season 3. Patients with Total Nasal Symptom Score >=6 and nasal congestion score greater than or equal to 2 4. Patients willing to provide written informed consent and comply with the protocol requirements 5. Patients literate enough to fill the diary card
Exclusion criteria
Exclusion criteria: 1. Patients with known hypersensitivity to Oxymetazoline, Fluticasone and / or any other drug of same class 2. Patients with allergic rhinitis with little or no seasonal exacerbations or nonallergic rhinitis 3. Patients with documented evidence of acute or chronic sinusitis, chronic purulent postnasal drip, rhinitis sicca, atrophic rhinitis or rhinitis medicamentosa as determined by the investigator. 4. Patients with nasal structure abnormalities, including nasal ulceration, nasal mucosal erosion, large nasal polyps, marked septal deviations and recent nasal surgery that significantly interfere with nasal air flow. 5. Patients with an active pulmonary disorder including asthma, upper respiratory tract or sinus infection that required antibiotic therapy within 14 days of the screening visit or a upper respiratory infection / ocular infection within 7 days of the screening visit. 6. Patients with history of narrow-angle glaucoma, increased intraocular pressure and posterior subcapsular cataract 7. Patients with abnormal laboratory values i.e. RBS > 140mg/dl, serum transaminases greater than or equal to 3 x Upper Normal Limit, serum bilirubin greater than or equal to 2.0 mg/dl and serum creatinine greater than or equal to 2.5 mg/dl 8. Patients with clinically significant uncontrolled systemic diseases such as gastrointestinal, cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy 9. Pregnant or lactating females and females of child bearing age not willing to use double methods of contraception during the study period 10. Patients who have received the following medications in the given time frame: nasal or oral decongestants, nasal or oral antihistamines: 72 h; nasal or inhaled corticosteroids, leucotriene receptor antagonists, 5-lipoxygenase inhibitors, methylxanthines, non-prescription drugs: 7 days; MAO inhibitors: 14 days; oral corticosteroids: 12 weeks 11. Patients taking prohibited concomitant medication 12. Patients with continuing history of alcohol and/or drug abuse 13. Participation in another clinical trial in the past 3 months prior to screening 14. Any other reason for which the investigator feels that the patient should not participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in TNSS (Night time) in the two groupsTimepoint: End of 3 days, 7 days, 14 days and 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving complete relief of symptomsTimepoint: End of 3 days, 7 days, 14 days and 28 days;Reduction in the individual symptom scores in the two groupsTimepoint: End of 3 days, 7 days, 14 days and 28 days;Reduction in TNSS (Day time) in the two groupsTimepoint: End of 3 days, 7 days, 14 days and 28 days;Reduction in TSS and TOSS in the two groupsTimepoint: End of 3 days, 7 days, 14 days and 28 days | — |
Countries
India
Contacts
Public ContactDr Jayesh Sanmukhani
Cadila Healthcare Limited
Outcome results
None listed