A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies

Official Title: “Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis”

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)

This will be a Phase III, randomized, double-blind, placebo-controlled, parallel-group study in subjects with moderate-to-severe seasonal allergic rhinitis (SAR). The study will begin with a 7-day, single-blind, 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). On Days 1 through 14, subjects will rate the instantaneous and reflective TNSS symptoms of sneezing, nasal congestion, runny nose, and nasal itching; the instantaneous and reflective total ocular symptom score (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. Additional secondary efficacy variables will include reflective individual nasal and ocular symptom scores, as well as change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).

Subjects ≥ 18 years of age will complete the 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.

Intervention(s) in this Clinical Trial

• Drug: Placebo
  • Placebo
• Drug: azelastine Hcl
  • azelastine Hcl 548 mcg
• Drug: azelastineHcl / fluticasone propionate
  • azelastine Hcl 548 mcg / fluticasone propionate 200 mcg
• Drug: fluticasone propionate
  • fluticasone propionate 200 mcg

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: fluticasone propionate
• Experimental: azelastineHcl/fluticasone propionate
• Placebo Comparator: Placebo
• Active Comparator: azelastine Hcl

Primary Measures

• change from baseline in 12-hour reflective total nasal symptom score
  • Time Frame: 14-days
    Safety Issue?: No

Secondary Measures

• Change from baseline in 12 hour instantaneous total nasal symptom score
  • Time Frame: 14-days
    Safety Issue?: No
• Onset of action assessment
  • Time Frame: 4 hours
    Safety Issue?: No
• Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
  • Time Frame: 14 days
    Safety Issue?: No
• Nasal examinations
  • Time Frame: 14 days
    Safety Issue?: Yes

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 wiling and able to provide informed consent and to participate all study procedures
• Positive skin test to a prevalent spring allergen

Exclusion criteria:

• On nasal examination,the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
• Nasal disease likely to affect the deposition of the medication or evaluation, such as sinus infection, nasal polyps or severe deviated septum
• Nasal or sinus surgery within the previous 6 months
• Chronic sinus infection (more than 3 per year)
• Planned travel outside the study area during the study period
• Use of any investigational drug within 30 days of the first visit
• Hypersensitivity (bad reaction) to azelastine hydrchloride nasal spray (Astelin), or fluticasone propionate nasal spray (Flonase)
• Women who are not using an acceptable method or birth control
• Women who are pregnant or nursing
• Upper respiratory tract infection such as common cold, flu, sinus infection within 2 weeks of first study visit
• Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with the investigator
• Irregular heartbeat or other symptomatic heart conditions
• History of alcohol or drug abuse
• History of glaucoma
• Use of medications that could affect the study results

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Meda Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Lewis M. Fredane, MD Study Director Meda Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00651118

Study ID Number: MP4002

ClinicalTrials.gov Identifier: NCT00651118

Health Authority: United States: Food and Drug Administration