Randomized, Double Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-036 in Patients With Seasonal Allergic Rhinitis

Meda Pharmaceuticals34 sites in 1 country481 target enrollmentAugust 2007

ConditionsSeasonal Allergic Rhinitis

InterventionsPlacebo nasal spray 0.15% azelastine hydrochloride Nasal Spray

DrugsPlacebo nasal spray 0.15% azelastine hydrochloride Nasal Spray

Overview

Phase: Phase 3
Intervention: Placebo nasal spray
Conditions: Seasonal Allergic Rhinitis
Sponsor: Meda Pharmaceuticals
Enrollment: 481
Locations: 34
Primary Endpoint: Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined)at 14 Days
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone

Registry

clinicaltrials.gov

Start Date

August 2007

End Date

November 2007

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Meda Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

•Male and female patients 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis
•Must be in generally good health
•Must meet minimum symptom requirements, as specified in the protocol
•Must be willing and able to provide informed consent and to participate in all study procedures
•Positive skin test to a prevalent fall allergen

Exclusion Criteria

•On focused Nasal Examination, the presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation at either the screening visit or randomization visit will disqualify the subject from the study.
•Other nasal disease(s)likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.
•Nasal Surgery or sinus surgery within the previous year
•Chronic sinusitis-more than 3 episodes a year
•Planned travel outside of the study area during the study period
•The use of any investigational drug within 30 days prior to screening. No investigational products are permitted for use during the conduct of the study.
•Presence of any hypersensitivity to drugs similar to azelastine and to either sorbital or sucralose (Splenda brand sweetener)
•Women who are pregnant or nursing
•Women of childbearing potential who are not abstinent or not practicing medically acceptable method of contraception
•Respiratory tract infection within 14 days prior to screening

Arms & Interventions

Placebo Nasal Spray

0mg Placebo Nasal Spray

Intervention: Placebo nasal spray

0.15% azelastine hydrochloride nasal spray

0.15% azelastine hydrochloride

Intervention: 0.15% azelastine hydrochloride Nasal Spray

Outcomes

Primary Outcomes

Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined)at 14 Days

Time Frame: baseline and 14 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 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

Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (tNSS) (AM) for the Entire 14-day Study Period Compared to Placebo(baseline and 14 days)
Change From Baseline in 12 Hour Instantaneous Total Nasal Sytmptom Score (AM and PM Combined)at 14 Days(baseline and 14-days)
Change From Baseline in 12-hour Reflective SSCS for the Entire 14-day Study Period Compared to Placebo (Am and PM Combined)(baseline and 14-days)
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at 14 Days(baseline and 14 Days)
Change From Baseline on Direct Visual Nasal Exams at 14 Days(baseline and 14 days)