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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Meda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00651118
First received: March 28, 2008
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

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)


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: Placebo
Drug: azelastine Hcl
Drug: azelastineHcl / fluticasone propionate
Drug: fluticasone propionate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Meda Pharmaceuticals:

Primary Outcome Measures:
  • Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (rTNSS) [ Time Frame: days 1 to 14 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS) [ Time Frame: day 1 to day 14 ] [ Designated as safety issue: No ]

    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.


  • Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days [ Time Frame: day 1 to day 14 ] [ Designated as safety issue: No ]

    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.



Enrollment: 832
Study Start Date: March 2008
Study Completion Date: July 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: fluticasone propionate Drug: fluticasone propionate
fluticasone propionate 200 mcg
Other Name: fluticasone
Experimental: azelastineHcl/fluticasone propionate Drug: azelastineHcl / fluticasone propionate
azelastine Hcl 548 mcg / fluticasone propionate 200 mcg
Other Name: MP29-02
Placebo Comparator: Placebo Drug: Placebo
placebo
Active Comparator: azelastine Hcl Drug: azelastine Hcl
azelastine Hcl 548 mcg
Other Name: azelastine

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651118

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

No publications provided

Responsible Party: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00651118     History of Changes
Other Study ID Numbers: MP4002
Study First Received: March 28, 2008
Results First Received: May 10, 2012
Last Updated: August 27, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Azelastine
Fluticasone
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Lipoxygenase Inhibitors
Enzyme Inhibitors
Anti-Allergic Agents
Therapeutic Uses
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on July 22, 2014