A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies - Full Text View

Sponsor:	Meda Pharmaceuticals
Information provided by:	Meda Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00651118

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 hydrochloride Drug: azelastine hydrochloride / fluticasone propionate Drug: fluticasone propionate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Allergy Hay Fever

Drug Information available for: Azelastine Azelastine hydrochloride Fluticasone propionate Fluticasone

U.S. FDA Resources

Further study details as provided by Meda Pharmaceuticals:

Primary Outcome Measures:

change from baseline in 12-hour reflective total nasal symptom score [ Time Frame: 14-days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in 12 hour instantaneous total nasal symptom score [ Time Frame: 14-days ] [ Designated as safety issue: No ]
Onset of action assessment [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Nasal examinations [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

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
3: Active Comparator fluticasone propionate nasal spray	Drug: fluticasone propionate fluticasone propionate 200 mcg
4: Experimental azelastine hydrochloride / fluticasone propionate	Drug: azelastine hydrochloride / fluticasone propionate azelastine hydrochloride 548 mcg / fluticasone propionate 200 mcg
1: Placebo Comparator Placebo	Drug: Placebo Placebo
2: Active Comparator azelastine hydrochloride	Drug: azelastine hydrochloride azelastine hydrochloride 548 mcg

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 sasonal 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

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

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Locations

United States, Arizona
Allergy, Asthma and Immunology Associates
Scottsdale, Arizona, United States, 85251
United States, California
Bensch Research Associates
Stockton, California, United States, 95207
Southern California Research
Mission Viejo, California, United States, 92691
Allergy Research Foundation
Los Angeles, California, United States, 90025
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, United States, 94598
Allergy and Asthma Medical Group and Research Center
San Diego, California, United States, 92123
Clinical Research Center
Encinitas, California, United States, 92024
Peninsula Research Associates
Rolling Hills Estates, California, United States, 90274
United States, Colorado
Colorado Allergy and Asthma Centers
Lakewood, Colorado, United States, 80401
Colorado Allergy and Asthma Centers
Denver, Colorado, United States, 80230
Storms Clinical Research Institute
Colorado Springs, Colorado, United States, 80907
United States, Georgia
Aeroallergy Research Laboratories of Savannah
Savannah, Georgia, United States, 31406
Clinical Research Atlanta
Atlanta, Georgia, United States, 30342
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
Plymouth, Minnesota, United States, 55441
Clinical Research Institute
Minneapolis, Minnesota, United States, 55402
United States, Missouri
The Clinical Research Center
St. Louis, Missouri, United States, 63141
United States, Nebraska
The Asthma and Allergy Center
Papillion, Nebraska, United States, 68046
Allergy, Asthma and Immunology Associates
Lincoln, Nebraska, United States, 68505
United States, New Jersey
Research Asthma, Sinus and Allergy Centers
Warren, New Jersey, United States, 07059
Atlantic Research Center
Ocean, New Jersey, United States, 07712
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 Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States, 15241
Asthma and Allergy Research Associate
Upland, Pennsylvania, United States, 19013
Allergy and Consultants of NJ/PA
Collegeville, Pennsylvania, United States, 19426
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
Central Texas Health Research
New Braunfels, Texas, United States, 78130
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
Sylvana Research Associates
San Antonio, Texas, United States, 78229
Allergy and Asthma Associates
Austin, Texas, United States, 78731
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 ( Harry Sacks, MD Vice President, Medical and Scientific Affairs )
Study ID Numbers:	MP4002
Study First Received:	March 28, 2008
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00651118 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Rhinitis
Azelastine
Hypersensitivity
Respiratory Tract Infections
Respiratory Tract Diseases
Therapeutic Uses
Fluticasone
Dermatologic Agents
Otorhinolaryngologic Diseases
Immune System Diseases

Anti-Asthmatic Agents
Histamine Agents
Enzyme Inhibitors
Anti-Allergic Agents
Nose Diseases
Pharmacologic Actions
Lipoxygenase Inhibitors
Histamine Antagonists
Autonomic Agents
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Histamine H1 Antagonists
Peripheral Nervous System Agents
Histamine H1 Antagonists, Non-Sedating
Bronchodilator Agents

ClinicalTrials.gov processed this record on November 27, 2009