Clinical trial NCT00720382: A Study to Evaluate the Safety and Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis
Official title: Active Controlled Trial of the Safety and Tolerability of MP 03-036 (Astepro 0.15%) in Patients With Perennial Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perennial Allergic Rhinitis
Lead sponsor: Meda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-07-22
Enrollment: 703
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if one allergy treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.


Eligibility criteria: Inclusion Criteria:

* Male and female patients 12 years and older with a compatible history greater than or equal to 1 year of rhinitis due to perennial allergies.
* Must be willing and able to provide informed consent and to participate in all study procedures
* Must be in generally good health
* Positive skin test to a prevalent perennial allergen

Exclusion Criteria:

* On nasal examination, the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
* Use of any investigational drug within 30 days of the first visit
* Any nasal surgery or sinus surgery within the previous year
* Presence of any hypersensitivity to drugs similar to azelastine or mometasone furoate and to either sorbital or sucralose
* Women who are pregnant or nursing
* Women who are not using an acceptable method of birth control
* Nasal Diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities.
* Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with investigator.
* Patients with Arrythmia
* Patients with know history of alcohol and drug abuse
* Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of the study.
* Use of medications that could affect the study results

Primary outcomes:
measure: Change From Baseline on Direct Visual Nasal Exams to 12 Months
timeFrame: Change from baseline to 12 months
Secondary outcomes:
Other outcomes:
measure: Change From Baseline to 12 Months in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older
timeFrame: change from baseline to 12 months
Locations:
city: Oxford
country: United States
facility: Center of Research Excellence, LLC
state: Alabama
city: Fountain Valley
country: United States
facility: AABI Associates Medical Group
state: California
city: Huntington Beach
country: United States
facility: Allergy and Asthma Specialist Medical Group
state: California
city: Long Beach
country: United States
facility: West Coast Clinical Trials
state: California
city: Los Angeles
country: United States
facility: Allergy Research Foundation
state: California
city: Mission Viejo
country: United States
facility: Southern California Research
state: California
city: San Diego
country: United States
facility: Allergy Associates Medical Group Inc
state: California
city: San Diego
country: United States
facility: Allergy and Asthma Medical Group and Research Center
state: California
city: San Jose
country: United States
facility: Allergy & Asthma Associates of Santa Clara Valley Research Cntr
state: California
city: Stockton
country: United States
facility: Bensch Research Associates
state: California
city: Walnut Creek
country: United States
facility: Allergy and Asthma Clinical Research, Inc.
state: California
city: Colorado Springs
country: United States
facility: Asthma and Allergy Associates
state: Colorado
city: Ocala
country: United States
facility: Allergy and Asthma Care of Florida
state: Florida
city: Tallahassee
country: United States
facility: Allergy and Asthma DTC
state: Florida
city: Albany
country: United States
facility: Georgia Pollens Clinical Research Centers Inc
state: Georgia
city: Savannah
country: United States
facility: Aeroallergy Research Laboratories of Savannah
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Normal
country: United States
facility: Sneeze, Wheeze and Itch Associates
state: Illinois
city: Overland Park
country: United States
facility: Kansas City Allergy and Asthma
state: Kansas
city: Metairie
country: United States
facility: RX R+D
state: Louisiana
city: Wheaton
country: United States
facility: Institute for Asthma and Allergy PC
state: Maryland
city: North Dartmouth
country: United States
facility: Northeast Medical Research Associates
state: Massachusetts
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Plymouth
country: United States
facility: Clinical Research Institute
state: Minnesota
city: St. Louis
country: United States
facility: The Clinical Research Center
state: Missouri
city: Papillion
country: United States
facility: The Asthma and Allergy Center
state: Nebraska
city: Henderson
country: United States
facility: Las Vegas Physicians Research Group
state: Nevada
city: Mount Laurel
country: United States
facility: Allergy and Asthma Research NJ inc
state: New Jersey
city: Ocean
country: United States
facility: Atlantic Research Center
state: New Jersey
city: Teaneck
country: United States
facility: Dr. Perin
state: New Jersey
city: North Syracuse
country: United States
facility: Medical Research Associates of CNY, PLLC
state: New York
city: Rochester
country: United States
facility: AAIR Research Center
state: New York
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: New Horizon's Clinical Research
state: Ohio
city: Edmond
country: United States
facility: Oklahoma Institute of Allergy and Asthma Clinical
state: Oklahoma
city: Oklahoma City
country: United States
facility: Allergy, Asthma and Clinical Research Center
state: Oklahoma
city: Lake Oswego
country: United States
facility: Allergy Asthma and Dermatology Research
state: Oregon
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon, PC
state: Oregon
city: Blue Bell
country: United States
facility: Allergy and Asthma Specialist PC
state: Pennsylvania
city: Collegeville
country: United States
facility: Allergy and Consultants of NJ/PA
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allergy and Clinical Immunology Associates
state: Pennsylvania
city: Upland
country: United States
facility: Asthma and Allergy Research Associate
state: Pennsylvania
city: Providence
country: United States
facility: Asthma, Nasal Disease & Allergy Research Center of New England
state: Rhode Island
city: Charleston
country: United States
facility: National Allergy, Asthma and Urticaria of Charleston
state: South Carolina
city: Austin
country: United States
facility: Allergy and Asthma Associates
state: Texas
city: Dallas
country: United States
facility: AARA Research Center
state: Texas
city: Dallas
country: United States
facility: Pharmaceutical Research & Consulting Inc
state: Texas
city: El Paso
country: United States
facility: Western Sky Medical Research
state: Texas
city: Houston
country: United States
facility: SWAAA Research Center
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Antonio
country: United States
facility: Biogenics Research Institute
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research Associates
state: Texas
city: San Antonio
country: United States
facility: Live Oak Allergy and Asthma Clinic
state: Texas
city: Waco
country: United States
facility: Allergy Asthma Research Institute
state: Texas
city: Richmond
country: United States
facility: VA Adult and Pediatric Allergy and Asthma
state: Virginia
city: Seattle
country: United States
facility: Asthma, Inc.
state: Washington
city: Milwaukee
country: United States
facility: Advanced Healthcare
state: Wisconsin
Study officials:
affiliation: Meda Pharmaceuticals
name: Lewis M. Fredane, MD
role: STUDY_DIRECTOR
References: