Clinical trial NCT00719862: A Study to Evaluate the Safety & Effectiveness of a Nasal Spray to Treat Seasonal Allergies
Official title: Randomized, Double Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-036 in Patients With Seasonal Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Meda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-07-22
Enrollment: 481
Sex: FEMALE
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 medication (0.15% azelastine hydrochloride) is more effective than Placebo alone


Eligibility 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 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.

Primary outcomes:
measure: Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined)at 14 Days
timeFrame: baseline and 14 days
Secondary outcomes:
measure: Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (tNSS) (AM) for the Entire 14-day Study Period Compared to Placebo
timeFrame: baseline and 14 days
measure: Change From Baseline in 12 Hour Instantaneous Total Nasal Sytmptom Score (AM and PM Combined)at 14 Days
timeFrame: baseline and 14-days
measure: Change From Baseline in 12-hour Reflective SSCS for the Entire 14-day Study Period Compared to Placebo (Am and PM Combined)
timeFrame: baseline and 14-days
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at 14 Days
timeFrame: baseline and 14 Days
measure: Change From Baseline on Direct Visual Nasal Exams at 14 Days
timeFrame: baseline and 14 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: 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: Lakewood
country: United States
facility: Colorado Allergy and Asthma centers, PC
state: Colorado
city: Tampa
country: United States
facility: University of South Florida
state: Florida
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: 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: Metairie
country: United States
facility: RX R+D
state: Louisiana
city: Baltimore
country: United States
facility: Chesapeake Clinical Research, Inc
state: Maryland
city: Wheaton
country: United States
facility: Institute for Asthma and Allergy PC
state: Maryland
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: Omaha
country: United States
facility: Midwest Allergy and Asthma Clinic
state: Nebraska
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: Verona
country: United States
facility: Allergy Consultants PA
state: New Jersey
city: Rochester
country: United States
facility: AAIR Research Center
state: New York
city: Edmond
country: United States
facility: OIAA Clinical Research, LLC
state: Oklahoma
city: Chester
country: United States
facility: Asthma and Allergy Research Associates
state: Pennsylvania
city: Easton
country: United States
facility: Valley Clinical Research
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC-ENT
state: Pennsylvania
city: Providence
country: United States
facility: Asthma, Nasal Disease & Allergy Research Center of New England
state: Rhode Island
city: Dallas
country: United States
facility: Pharmaceutical Research & Consulting Inc
state: Texas
city: Dallas
country: United States
facility: Jane Lee, MD, PA Research Center
state: Texas
city: El Paso
country: United States
facility: Western Sky Medical Research
state: Texas
city: Waco
country: United States
facility: Allergy Asthma Research Institute
state: Texas
city: Milwaukee
country: United States
facility: Advanced Healthcare, SC
state: Wisconsin
city: Novi
country: United States
facility: Allergy and Asthma Center of Michigan
state: Wisconsin
Study officials:
affiliation: Meda Pharmaceuticals
name: Lewis M Fredane, MD
role: STUDY_DIRECTOR
References: