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

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

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

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: Placebo nasal spray; Drug: 0.15% azelastine hydrochloride Nasal Spray

• Study Type: Interventional
• Enrollment (Actual): 481
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Huntington Beach, California, United States, 92647
      • Allergy and Asthma Specialist Medical Group
    • Long Beach, California, United States, 90806
      • Allergy, Asthma and Respiratory Care medical Center
    • San Diego, California, United States, 92123
      • Allergy and Asthma Medical Group and Research Center
    • San Jose, California, United States, 95117
      • Allergy & Asthma Associates of Santa Clara Valley Research Cntr
    • Stockton, California, United States, 95207
      • Bensch Research Associates
  • Colorado
    • Lakewood, Colorado, United States, 80401
      • Colorado Allergy and Asthma Centers, PC
  • Florida
    • Tampa, Florida, United States, 33613
      • University of South Florida
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Aeroallergy Research Laboratories of Savannah
    • Stockbridge, Georgia, United States, 30281
      • Clinical Research Atlanta
    • Woodstock, Georgia, United States, 30188
      • Atlanta Allergy and Asthma Clinic
  • Illinois
    • Normal, Illinois, United States, 61761
      • Sneeze, Wheeze and Itch Associates
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • Kansas City Allergy and Asthma
  • Louisiana
    • Metairie, Louisiana, United States, 70001
      • RX R+D
  • Maryland
    • Baltimore, Maryland, United States, 21236
      • Chesapeake Clinical Research, Inc
    • Wheaton, Maryland, United States, 20902
      • Institute for Asthma and Allergy PC
  • Minnesota
    • Plymouth, Minnesota, United States, 55441
      • Clinical Research Institute
  • Missouri
    • St. Louis, Missouri, United States, 63141
      • The Clinical Research Center
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Midwest Allergy and Asthma Clinic
    • Papillion, Nebraska, United States, 68046
      • The Asthma and Allergy Center
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Las Vegas Physicians Research Group
  • New Jersey
    • Mount Laurel, New Jersey, United States, 08054
      • Allergy and Asthma Research NJ inc
    • Verona, New Jersey, United States, 07044
      • Allergy Consultants PA
  • New York
    • Rochester, New York, United States, 14618
      • AAIR Research Center
  • Oklahoma
    • Edmond, Oklahoma, United States, 73003
      • OIAA Clinical Research, LLC
  • Pennsylvania
    • Chester, Pennsylvania, United States, 19013
      • Asthma and Allergy Research Associates
    • Easton, Pennsylvania, United States, 18045
      • Valley Clinical Research
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC-ENT
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Asthma, Nasal Disease & Allergy Research Center of New England
  • Texas
    • Dallas, Texas, United States, 75231
      • Pharmaceutical Research & Consulting Inc
    • Dallas, Texas, United States, 75246
      • Jane Lee, MD, PA Research Center
    • El Paso, Texas, United States, 79902
      • Western Sky Medical Research
    • Waco, Texas, United States, 76712
      • Allergy Asthma Research Institute
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53209
      • Advanced Healthcare, SC
    • Novi, Wisconsin, United States, 48375
      • Allergy and Asthma Center of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

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 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
• Respiratory tract infections requiring antibiotic treatment 14 days prior to screening
• Asthma (with the exception of mild, intermittent asthma). Subjects with mild, intermittent asthma who only require short-acting inhaled bronchodilators (not for more often tha twice a week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment
• Significant pulmonary disease including COPD
• Clinically significant arrythmia or symptomatic cardiac conditions
• A known history of alcohol or drug abuse within the last 2 years
• Existence of any surgical or medical condition or physical laboratory findings, which in the opinion of the investigator or sponsor's medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug; that might significantly affect the subject's ability to complete this trial; or their safety in this trial
• Clinically relevant abnormal physical findings which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo Nasal Spray; 0mg Placebo Nasal Spray	Drug: Placebo nasal spray; Placebo
ACTIVE_COMPARATOR: 0.15% azelastine hydrochloride nasal spray; 0.15% azelastine hydrochloride	Drug: 0.15% azelastine hydrochloride Nasal Spray; 0.15% azelastine hydrochloride 822 mcg; Other Names: astepro 0.15%

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 (AM and PM Combined)at 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.	baseline and 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (tNSS) (AM) for the Entire 14-day Study Period Compared to Placebo	End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous tNSS for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous tNSS consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. 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 baseline as a covariate.	baseline and 14 days
Change From Baseline in 12 Hour Instantaneous Total Nasal Sytmptom Score (AM and PM Combined)at 14 Days	instantaneous (subjects rate how they feel "right now") 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.	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)	Reflective secondary symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS 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.	baseline and 14-days
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at 14 Days	A 28-item RQLQ was completed on Day 1 and Day 14 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time. Total overall score is not calculated by adding all subscales scores for an overall score. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.	baseline and 14 Days
Change From Baseline on Direct Visual Nasal Exams at 14 Days	Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None,Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation	baseline and 14 days

Collaborators and Investigators

• Sponsor: Meda Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (ACTUAL): November 1, 2007
• Study Completion (ACTUAL): November 1, 2007

Study Registration Dates

• First Submitted: July 21, 2008
• First Submitted That Met QC Criteria: July 21, 2008
• First Posted (ESTIMATE): July 22, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): February 2, 2010
• Last Update Submitted That Met QC Criteria: January 27, 2010
• Last Verified: January 1, 2010

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; 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; Azelastine
• Other Study ID Numbers: MP439