Clinical trial NCT00660517
Conditions: Seasonal Allergic Rhinitis
Sponsor: Meda Pharmaceuticals
Start date: 2007-12-01; Completion date: 2008-04-01
Enrollment: 607 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)

Detailed description:
This will be a Phase III, randomized, double-blind, parallel-group study in subjects with moderate-to-severe SAR. The study will be conducted at 8 investigational sites during the 2007-2008 Texas Mountain Cedar allergy season. After a 7-day Placebo Lead-In Period (Day -7 to Day 1), subjects will be instructed to take placebo lead-in medication twice daily (1 spray per nostril), approximately every 12 hours. On Day 1, subjects who satisfy the symptom severity requirements and continue to meet all of the study inclusion/exclusion criteria will be randomized in a 1:1:1:1 ratio to receive 1 spray per nostril twice daily of MP29-02, azelastine hydrochloride, fluticasone propionate, or placebo nasal spray.

Efficacy will be assessed by the change from baseline in the subject-reported 12-hour reflective Total Nasal Symptom Score (TNSS), consisting of the sum of the scores of sneezing, nasal congestion, runny nose, and nasal itching. On Days -7 through 14, subjects will rate the TNSS symptoms, the TOSS symptoms of itchy eyes, watery eyes and eye redness, and the symptom of postnasal drip twice daily (AM and PM) in a diary prior to the dose of study medication. Symptoms will be scored on a 0 to 3 scale (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms), such that the maximum daily symptom severity score will be 24 for the TNSS and 18 for the TOSS. The 12-hour reflective TNSS, the instantaneous TNSS, the 12-hour reflective score for postnasal drip, the 12-hour reflective TOSS, and the instantaneous TOSS will be calculated based on these scores. Additional secondary efficacy variables will include reflective and individual nasal and ocular symptom scores and change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).

Subjects ≥ 18 years of age will complete the adult RQLQ on Day 1 (prior to dosing) and Day 14. Subjects will return to the clinic on Day 7 for an interim evaluation. After completing the 2-week double-blind treatment period, subjects will return to the clinic on Day 14 (or at time of early termination) for an end-of-study evaluation. Safety and tolerability assessments will be made on Days 7 and 14. Tolerability will be evaluated by subject reported adverse events (AEs), nasal examinations, and vital signs assessments.

Arms: arm 1: azelastine HCl 548 mcg / fluticasone propionate 200 mcg nasal spray arm 2: azelastine Hcl 548 mcg nasal spray arm 3: fluticasone propionate 200 mcg nasal spray arm 4: placebo nasal spray
Interventions: intervention 1: MP29-02 intervention 2: azelastine Hcl intervention 3: fluticasone propionate intervention 4: placebo
Intervention descriptions: intervention 1: azelastine HCl 548 mcg / fluticasone propionate 200 mcg nasal spray one spray per nostril twice a day intervention 2: azelastine Hcl nasal spray one spray per nostril two times a day intervention 3: fluticasone propionate 200 mcg nasal spray one spray per nostril two times a day intervention 4: placebo nasal spray one spray per nostril two times a day

Protocol documents: