0.15% azelastine hydrochloride
Drug1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM
NCT Number: NCT00720382
The purpose of this study is to determine if one allergy treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.
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Notify Me12 year and older
All sexes
Interventional
Phase 3
Center of Research Excellence, LLC, Oxford, Alabama, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM
200 mcg (50 mcg/spray) 2 sprays per nostril Once a day (AM)
Time frame: Change from baseline to 12 months
Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irritation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation
Time frame: change from baseline to 12 months
A 28-item RQLQ was completed on Day 1, Month 1, Month 3, Month 6, month 9 and month 12 or Early termination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.
Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.
Meda Pharmaceuticals
Industry
Active Controlled Trial of the Safety and Tolerability of MP 03-036 (Astepro 0.15%) in Patients With Perennial Allergic Rhinitis
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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