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

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)

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: Placebo; Drug: fluticasone propionate; Drug: azelastineHcl / fluticasone propionate; Drug: azelastine Hcl

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 832
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Allergy, Asthma and Immunology Associates
  • California
    • Encinitas, California, United States, 92024
      • Clinical Research Center
    • Los Angeles, California, United States, 90025
      • Allergy Research Foundation
    • Mission Viejo, California, United States, 92691
      • Southern California Research
    • Rolling Hills Estates, California, United States, 90274
      • Peninsula Research Associates
    • San Diego, California, United States, 92123
      • Allergy and Asthma Medical Group and Research Center
    • Stockton, California, United States, 95207
      • Bensch Research Associates
    • Walnut Creek, California, United States, 94598
      • Allergy and Asthma Clinical Research, Inc.
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Storms Clinical Research Institute
    • Denver, Colorado, United States, 80230
      • Colorado Allergy and Asthma Centers
    • Lakewood, Colorado, United States, 80401
      • Colorado Allergy and Asthma Centers
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Clinical Research Atlanta
    • Savannah, Georgia, United States, 31406
      • Aeroallergy Research Laboratories of Savannah
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
  • Illinois
    • Normal, Illinois, United States, 61761
      • Sneeze, Wheeze and Itch Associates
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Kansas City Allergy and Asthma
  • Massachusetts
    • North Dartmouth, Massachusetts, United States, 02747
      • Northeast Medical Research Associates
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute
    • Plymouth, Minnesota, United States, 55441
      • Clinical Research Institute
  • Missouri
    • St. Louis, Missouri, United States, 63141
      • The Clinical Research Center
  • Nebraska
    • Lincoln, Nebraska, United States, 68505
      • Allergy, Asthma and Immunology Associates
    • Papillion, Nebraska, United States, 68046
      • The Asthma and Allergy Center
  • New Jersey
    • Ocean, New Jersey, United States, 07712
      • Atlantic Research Center
    • Warren, New Jersey, United States, 07059
      • Research Asthma, Sinus and Allergy Centers
  • New York
    • Rochester, New York, United States, 14618
      • AAIR Research Center
    • Rockville Center, New York, United States, 11570
      • Island Medical Research
  • North Carolina
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Clinical Research
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • Bernstein Clinical Research Center
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74133
      • Allergy Clinic of Tulsa
  • Oregon
    • Lake Oswego, Oregon, United States, 97035
      • Allergy Asthma and Dermatology Research
  • Pennsylvania
    • Collegeville, Pennsylvania, United States, 19426
      • Allergy and Consultants of NJ/PA
    • Pittsburgh, Pennsylvania, United States, 15241
      • Allergy and Clinical Immunology Associates
    • Upland, Pennsylvania, United States, 19013
      • Asthma and Allergy Research Associate
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • National Allergy, Asthma and Urticaria of Charleston
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • East Tennesse Center for Clinical Research
  • Texas
    • Austin, Texas, United States, 78731
      • Allergy and Asthma Associates
    • Austin, Texas, United States, 78759
      • Allergy and Asthma Center of Austin
    • Dallas, Texas, United States, 75231
      • AARA Research Center
    • Dallas, Texas, United States, 75246
      • Jane Lee, MD, PA Research Center
    • New Braunfels, Texas, United States, 78130
      • Central Texas Health Research
    • San Antonio, Texas, United States, 78229
      • Sylvana Research Associates
  • Utah
    • Draper, Utah, United States, 84020
      • Intermountain Clinical Research
  • Washington
    • Seattle, Washington, United States, 98105
      • ASTHMA, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; placebo
Active Comparator: azelastine Hcl	Drug: azelastine Hcl; azelastine Hcl 548 mcg; Other Names: azelastine
Active Comparator: fluticasone propionate	Drug: fluticasone propionate; fluticasone propionate 200 mcg; Other Names: fluticasone
Experimental: azelastineHcl/fluticasone propionate	Drug: azelastineHcl / fluticasone propionate; azelastine Hcl 548 mcg / fluticasone propionate 200 mcg; Other Names: MP29-02

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (rTNSS)	change from baseline in 12-hour reflective(how did you feel in the last 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period. The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative value the better the result.	days 1 to 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)	change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period. The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative the value the better the result.	day 1 to day 14
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days	adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14. The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement.The more negative the value the better the result.	day 1 to day 14

Collaborators and Investigators

• Sponsor: Meda Pharmaceuticals
• Investigators: Study Director: Lewis M. Fredane, MD, Meda Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: March 28, 2008
• First Submitted That Met QC Criteria: March 28, 2008
• First Posted (Estimate): April 2, 2008

Study Record Updates

• Last Update Posted (Estimate): September 26, 2012
• Last Update Submitted That Met QC Criteria: August 27, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Lipoxygenase Inhibitors; Fluticasone; Xhance; Azelastine
• Other Study ID Numbers: MP4002