Health Condition 1: null- Seasonal Allergic Rhinitis
Conditions
Interventions
Intervention1: 1. Fixed Dose Combination of Azelastine hydrochloride and Mometasone furoate Nasal Spray: The dose is 1 or 2 sprays per nostril once or twice daily for two weeks
Control Intervention1:
Sponsors
Glenmark Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients age >=12 and 2. The combined score of nasal symptoms (nasal congestion, rhinorrhea, nasal itching and sneezing) must be at least 6; and nasal congestion severity score must be at least 2 at screening. 3. Patient with a documented clinical history of Seasonal Allergic Rhinitis with exacerbations during the study season and/or exhibiting a positive skin prick test 4. Patient with ability to understand and sign written informed consent form, which must have been obtained prior to screening. Subjects under the legal age of consent must have provided assent and have had the written informed consent of the parent or guardian.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. 2. Patients with known hypersensitivity to any of the components of the formulation. 3. Patients with a history of anaphylaxis and/or other severe local reaction(s) to skin testing 4. Patients with alcohol or drug dependence. 5. Patients with perennial rhinitis with little or no seasonal exacerbations; non-allergic rhinitis or ocular infection within 3 weeks before the screening. 6. Patients with documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip or Rhinitis Medicamentosa as determined by the investigator. 7. Patients with a history of psychiatric illness. 8. Patients with nasal structure abnormalities, including nasal ulceration, nasal mucosal erosion, large nasal polyps and marked septal deviations that significantly interfere with nasal air flow. 9. Patients with an active pulmonary disorder, upper respiratory tract or sinus infection that required antibiotic therapy at least 14 day prior to the Screening Visit or a viral upper respiratory infection within 7 days before the Screening Visit. 10. Patients with history of narrow-angle glaucoma, increased intraocular pressure, posterior subcapsular cataract, urinary retention, hypertension, severe Coronary Artery Disease, Ischemic Heart Disease, Diabetes Mellitus, Hyperthyroidism, Renal Impairment or Prostatic Hypertrophy, and those receiving monoamine oxidase (MAO) inhibitor therapy. 11. Patients with current evidence of clinically significant hematopoietic, cardiovascular, hepatic renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the subjectâ??s participation in the study. Particular attention should be given to exclude subjects with conditions that would currently interfere with the absorption, distribution, metabolism or excretion of the study drug or interfere with the subjectâ??s ability to complete or reliably complete the patientâ??s diary. 12. Patients who have participated in any clinical trial in the past 1 month
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in Total Nasal Symptoms Score from Baseline to End of treatment.Timepoint: Time Point: 14 days (two weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in individual symptom scores from Baseline to End of treatment.Timepoint: Time Point: 14 days (two weeks).;Mean change in Rhinoconjunctivitis Quality-of-Life Score (RQOL) from Baseline to End of treatment.Timepoint: Time point: 14 days (two weeks).;Patients Self Evaluation for overall Response to Treatment at the End of treatment.Timepoint: Time point: 14 days (two weeks). | — |
Countries
India
Contacts
Public ContactDr Shailendra Sachan
Glenmark Pharmaceuticals Ltd
Outcome results
None listed