Clinical study to evaluate the efficacy and safety of FluticasoneFuroate and Oxymetazoline Hydrochloride Nasal Spray 27.5 / 50 mcg as compared to Fluticasone Furoate Nasal Spray 27.5mcg in patients with allergic rhinitis

Phase 3

• Conditions: Health Condition 1: J308- Other allergic rhinitis

• Registration Number: CTRI/2020/10/028347
• Lead Sponsor: Cadila Healthcare Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified