Clinical trial NCT00651118: A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Seasonal Allergic Rhinitis
Lead sponsor: Meda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-04-02
Enrollment: 832
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 (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)

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 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

Primary outcomes:
measure: Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (rTNSS)
timeFrame: days 1 to 14
Secondary outcomes:
measure: Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)
timeFrame: day 1 to day 14
measure: Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days
timeFrame: day 1 to day 14
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Allergy, Asthma and Immunology Associates
state: Arizona
city: Encinitas
country: United States
facility: Clinical Research 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: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates
state: California
city: San Diego
country: United States
facility: Allergy and Asthma Medical Group and Research Center
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: Storms Clinical Research Institute
state: Colorado
city: Denver
country: United States
facility: Colorado Allergy and Asthma Centers
state: Colorado
city: Lakewood
country: United States
facility: Colorado Allergy and Asthma Centers
state: Colorado
city: Atlanta
country: United States
facility: Clinical Research Atlanta
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: 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: Lincoln
country: United States
facility: Allergy, Asthma and Immunology Associates
state: Nebraska
city: Papillion
country: United States
facility: The Asthma and Allergy Center
state: Nebraska
city: Ocean
country: United States
facility: Atlantic Research Center
state: New Jersey
city: Warren
country: United States
facility: Research Asthma, Sinus and Allergy Centers
state: New Jersey
city: Rochester
country: United States
facility: AAIR Research Center
state: New York
city: Rockville Center
country: United States
facility: Island Medical Research
state: New York
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center
state: Ohio
city: Tulsa
country: United States
facility: Allergy Clinic of Tulsa
state: Oklahoma
city: Lake Oswego
country: United States
facility: Allergy Asthma and Dermatology Research
state: Oregon
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: Charleston
country: United States
facility: National Allergy, Asthma and Urticaria of Charleston
state: South Carolina
city: Knoxville
country: United States
facility: East Tennesse Center for Clinical Research
state: Tennessee
city: Austin
country: United States
facility: Allergy and Asthma Associates
state: Texas
city: Austin
country: United States
facility: Allergy and Asthma Center of Austin
state: Texas
city: Dallas
country: United States
facility: AARA Research Center
state: Texas
city: Dallas
country: United States
facility: Jane Lee, MD, PA Research Center
state: Texas
city: New Braunfels
country: United States
facility: Central Texas Health Research
state: Texas
city: San Antonio
country: United States
facility: Sylvana Research Associates
state: Texas
city: Draper
country: United States
facility: Intermountain Clinical Research
state: Utah
city: Seattle
country: United States
facility: Asthma, Inc.
state: Washington
Study officials:
affiliation: Meda Pharmaceuticals
name: Lewis M. Fredane, MD
role: STUDY_DIRECTOR
References: