Clinical trial NCT00712920: A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergies
Official title: Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 and MP03-33 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: 2008-07-10
Enrollment: 581
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 two allergy medications are more effective than placebo.


Eligibility criteria: Inclusion Criteria:

* Male and female patients 12 years of age and older
* Must be in generally good health
* Must meet minimum symptom requirements, as specified in protocol
* Must be willing and able to provide informed consent and participate in all study procedures
* 2-year history of PAR
* Positive skin test to cockroach, dust mite, mold or cat/dog dander

Exclusion Criteria:

* On nasal examination, presence of any nasal mucosal erosion, nasal ulceration or nasal septal perforation at the screening or randomization visit
* Nasal diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, significant polyposis or nasal structural abnormalities
* Nasal surgery or sinus surgery within the previous year
* The use of any investigational drug within 30 days
* Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose
* Women who are pregnant or nursing
* Women of child-bearing potential who are not abstinent and not practicing a medically acceptable method of contraception
* Respiratory tract infection within 2 weeks of screening
* Respiratory tract infections requiring oral antibiotic treatment within 2 weeks of screening
* Patients with asthma with the exception of mild, intermittent
* Significant pulmonary disease including COPD
* Patients with arrhythmia
* Patients with a known history of alcohol or drug abuse
* Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor may significantly alter the absorption, distribution, metabolism or excretion of study drug.
* Clinically relevant abnormal physical findings within one week of randomization
* Overnight abscences from home for more than 3 nights
* Employees of the research center or private practice and family members are excluded
* Patients who received prohibited medications within specified timepoints in protocol.

Primary outcomes:
measure: Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.
timeFrame: baseline and 28 days
Secondary outcomes:
measure: Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days
timeFrame: baseline and 28 days
measure: Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days
timeFrame: baseline and 28 days
measure: Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days
timeFrame: baseline and 28 Days
measure: Change From Baseline on Direct Visual Nasal Exams and 28 Days
timeFrame: baseline and 28 days
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Allergy and Asthma Specialist Medical Group
state: California
city: Long Beach
country: United States
facility: Allergy, Asthma and Respiratory Care medical Center
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: 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: Colorodo Springs
country: United States
facility: The William Storms Allergy Clinic
state: Colorado
city: Woodstock
country: United States
facility: Atlanta Allergy and Asthma Clinic
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: 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: 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: 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: 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: Collegeville
country: United States
facility: Allergy and Consultants of NJ/PA
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: New Braunfels
country: United States
facility: Central Texas 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: Waco
country: United States
facility: Allergy and Asthma Center
state: Texas
city: Richmond
country: United States
facility: Virginia Adult & Pediactric Allergy & Asthma, PC
state: Virginia
city: Seattle
country: United States
facility: Asthma, Inc.
state: Washington
city: Milwaukee
country: United States
facility: Advanced Healthcare, SC
state: Wisconsin
Study officials:
References: