A clinical trial to study the effect of FDC of Azelastine and Mometasone Nasal Spray in Patients with Seasonal Allergic Rhinitis (symptoms similar to those of a cold such as runny nose and sore throat, caused by an allergic reaction to an allergen such as dust, plant pollens or animal dander)
- Conditions
- Health Condition 1: null- Seasonal Allergic Rhinitis
- Registration Number
- CTRI/2013/01/003334
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 560
1. Patients age >=12 and <= 65 years inclusive of either sex.
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method