Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 and MP03-33 in Patients With Perennial Allergic Rhinitis
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Perennial Allergic Rhinitis
- Sponsor
- Meda Pharmaceuticals
- Enrollment
- 581
- Locations
- 42
- Primary Endpoint
- Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
The purpose of this study is to determine if two allergy medications are more effective than placebo.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female patients 12 years of age and older
- •Must be in generally good health
- •Must meet minimum symptom requirements, as specified in protocol
- •Must be willing and able to provide informed consent and participate in all study procedures
- •2-year history of PAR
- •Positive skin test to cockroach, dust mite, mold or cat/dog dander
Exclusion Criteria
- •On nasal examination, presence of any nasal mucosal erosion, nasal ulceration or nasal septal perforation at the screening or randomization visit
- •Nasal diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, significant polyposis or nasal structural abnormalities
- •Nasal surgery or sinus surgery within the previous year
- •The use of any investigational drug within 30 days
- •Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose
- •Women who are pregnant or nursing
- •Women of child-bearing potential who are not abstinent and not practicing a medically acceptable method of contraception
- •Respiratory tract infection within 2 weeks of screening
- •Respiratory tract infections requiring oral antibiotic treatment within 2 weeks of screening
- •Patients with asthma with the exception of mild, intermittent
Arms & Interventions
1
Placebo
Intervention: Placebo
2
0.15% azelastine hydrochloride 1644 mcg/2 sprays per nostril 2 times a day for 4 weeks
Intervention: 0.15% azelastine hydrochloride
3
0.1% azelastine hydrochloride 1096 mcg/2 sprays per nostril 2 times a day for 4 weeks
Intervention: 0.1% azelastine hydrochloride
Outcomes
Primary Outcomes
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.
Time Frame: baseline and 28 days
Reflective total nasal symptom score consisting of Runny nose, itchy nose, nasal Congestion, and Sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day Least square means (LS Mean) was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.
Secondary Outcomes
- Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days(baseline and 28 days)
- Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days(baseline and 28 days)
- Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days(baseline and 28 Days)
- Change From Baseline on Direct Visual Nasal Exams and 28 Days(baseline and 28 days)