Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 (0.15% Solution) and MP03-33 (0.10% Solution) in Children Ages >6 to <12 With Perennial Allergic Rhinitis
Overview
- Phase
- Phase 3
- Intervention
- Azelastine hydrochloride nasal spray 0.15%
- Conditions
- Perennial Allergic Rhinitis
- Sponsor
- Meda Pharmaceuticals
- Enrollment
- 489
- Locations
- 39
- Primary Endpoint
- Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) for the Entire 28-day Study Period Compared to Placebo
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief Summary
The purpose of this study is to compare the effectiveness of an Investigational use of an allergy medication (MP03-33) used to treat perennial allergic rhinitis (PAR) to placebo (a nasal spray that contains no medicine). In addition, the study will also compare the safety and effectiveness of an investigational use of another allergy medication (MP03-36) used to treat perennial allergic rhinitis to placebo.
Detailed Description
in Children Ages \>6 to \<12 with Perennial Allergic Rhinitis (PAR)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female subjects \>6-\<12, inclusive at the screening visit
- •At least a 1-year history of PAR
- •The parent must provide written informed consent and the child must provide written assent.
- •Willing and able to comply with the study requirements
- •The presence of immunoglobulin E (IgE)-mediated hypersensitivity to dust mite, cockroach, mold, cat or dog dander, confirmed by a positive response to skin prick testing at the Visit
- •A positive response is defined as a wheal diameter of ≥5 mm larger than the negative control for the skin prick test. Histamine control must also be positive with a wheal diameter \>5 mm larger than the control. If there are prevailing seasonal allergies, the subject must have a negative skin test to the specific allergen.
- •Screening Visit: Have a 12-hour reflective TNSS of at least 6 out of a possible 12 and a congestion score of ≥2 or a rhinorrhea score of ≥2 on Visit 1
- •Randomization Visit: to be eligible for entry into the double-blind treatment period, subjects/caregivers must record:
- •at least 3 symptom assessments (either AM or PM score) during the past 3 days of the Lead-In Period or the Day of Randomization:
- •a 12-hour reflective TNSS ≥ 6
Exclusion Criteria
- •On nasal examination, subjects with superficial nasal mucosal erosion, moderate nasal mucosal erosion, nasal mucosal ulceration, nasal septum perforation (Grade 1B - 4) (see section 8.1.4).
- •Other nasal disease(s) likely to affect deposition of intranasal medication, such as acute sinusitis, rhinitis medicamentosa or clinically significant polyposis or nasal structural abnormalities.
- •Nasal surgery or sinus surgery within the previous year.
- •Chronic sinusitis
- •The use of any investigational drug within 30 days prior to Visit
- •No investigational products are permitted for use during the conduct of this study
- •Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
- •Females who are pregnant or nursing
- •Females of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception
- •Respiratory tract infections within two weeks prior to Visit 1
Arms & Interventions
MP03-36 (0.15% solution)
822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
Intervention: Azelastine hydrochloride nasal spray 0.15%
MP03-33 (0.10% solution)
548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
Intervention: Azelastine hydrochloride nasal spray 0.10%
Placebo
0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) for the Entire 28-day Study Period Compared to Placebo
Time Frame: baseline to 28 Days
Change from baseline in 12-hour reflective total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms.
Secondary Outcomes
- Change From Baseline in the Instantaneous Total Nasal Symptoms Score (TNSS) for the Entire 28-day Study Period Compared to Placebo(baseline to 28 days)
- Change From Baseline in 12-hour Reflective Total Ocular Symptoms Score (TOSS) and Instantaneous Total Ocular Symptoms Score (TOSS) for the Entire 28-day Study Period Compared to Placebo(baseline to 28 days)
- Change From Baseline to Visit 4 in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Compared to Placebo(baseline to 28 Days)