Clinical trial NCT01368445: A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Seasonal Allergies
Official title: Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 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: 2011-06-08
Enrollment: 617
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The Purpose of this study is to evaluate the safety and efficacy of MP03-36 (0.15% azelastine hydrochloride)at dosages of 2 sprays per nostril once daily and 2 sprays per nostril twice daily in patients with seasonal allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Male and female patients 12 years of age and older
* Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent
* Screening Visit: Have a 12-hour reflective total nasal symptoms score ( TNSS) of at least 8 out of a possible 12 and a congestion score of 2 or 3 on Day -7
* Randomization Visit: Have a 12-hour reflective total nasal symptoms score (TNSS) (AM or PM) of at least 8 on 3 separate assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) during the Lead-in Period. In addition, an AM or PM nasal congestion score of 2 or 3 must have been recorded on 3 separate assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1).
* Must have taken at least 10 doses of study medication during the lead-in period
* Randomization Visit: An instantaneous (TNSS) of ≥ 8 before beginning the onset of action assessment on Day 1
* Willing and able to comply with the study requirements
* At least a 2-year history of seasonal allergic rhinitis (SAR) during the fall pollen allergy season
* The presence of IgE-mediated hypersensitivity to local fall pollen confirmed by a positive response to either skin prick or intradermal testing within the last year. A positive response is defined as a wheal diameter of at least 3 mm larger than the control for the skin prick test or at least 7 mm larger than the control for the intradermal test.
* General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor's medical officer
* Patients receiving immunotherapy injections (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit (adjustments to regimen following a brief period of missed injections does not preclude participation). Patients who are on maintenance doses of sublingual immunotherapy may be considered for the trial on a case-by-case basis after discussion with the sponsor's medical monitor or designee.

Exclusion Criteria:

* The use of any investigational drug within 30 days prior to Day -7. No investigational products are permitted for use during the conduct of this study
* Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
* Women who are pregnant or nursing
* Women of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception
* Respiratory tract infections within two weeks prior to Day -7
* Respiratory Infections requiring oral antibiotic treatment two weeks prior to Day -7
* Other nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant polyposis or nasal structural abnormalities
* Patients with asthma (with the exception of mild, intermittent asthma)
* Patients with significant pulmonary disease
* 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, might significantly alter the absorption, distribution, metabolism, or excretion of study drug
* Clinically relevant abnormal physical findings within 1 week of randomization which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures
* Planned travel outside the study area during the study period
* Family members and employees should be excluded
* Patients who received prohibited medications within specified timepoints in the protocol.

Primary outcomes:
measure: Change from baseline in 12-hour reflective total nasal symptoms score(TNSS) for the entire 14-day study period compared to placebo
timeFrame: 14 Days
Secondary outcomes:
measure: Change from baseline in instantaneous total nasal symptoms score (TNSS) for the entire 14-day study period compared to placebo
timeFrame: 14 Days
measure: Change from baseline to Day 14 in Roland Quality of Life Questionnaire (RQLQ )compared to placebo
timeFrame: 14 Days
measure: Change From Baseline on Direct Visual Nasal Exams
timeFrame: 14 Days
Other outcomes:
Locations:
city: Fountain Valley
country: United States
facility: AABI Associates 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: Roseville
country: United States
facility: Allergy Medical Group
state: California
city: San Diego
country: United States
facility: Allergy Associates Medical Group
state: California
city: San Jose
country: United States
facility: Allergy and Asthma Associates of CA
state: California
city: Colorado Springs
country: United States
facility: The William Storms Allergy Clinic
state: Colorado
city: Denver
country: United States
facility: Colorado Allergy and Asthma Centers, PC
state: Colorado
city: Savannah
country: United States
facility: Coastal Allergy and Asthma P.C.
state: Georgia
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, P.C.
state: Maryland
city: N. Dartmouth
country: United States
facility: Northeast Medical Research Associates, Inc.
state: Massachusetts
city: Minneapolis
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Papillion
country: United States
facility: The Asthma and Allergy Center, PC
state: Nebraska
city: Ocean
country: United States
facility: Atlantic Allergy, Asthma & Immunology
state: New Jersey
city: Skillman
country: United States
facility: Princeton Center for Clinical Research
state: New Jersey
city: Rochester
country: United States
facility: Allergy and Asthma Institue of Rochester
state: New York
city: Raleigh
country: United States
facility: North Carolina Clinical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Clinical Research Center
state: Ohio
city: Edmond
country: United States
facility: Oklahoma Institute of Allergy and Asthma
state: Oklahoma
city: Collegeville
country: United States
facility: Allergy and Asthma Consultants of NJ-PA, P.C
state: Pennsylvania
city: Easton
country: United States
facility: Valley Clinical Research Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allergy and Clinical Immunology Associates
state: Pennsylvania
city: Austin
country: United States
facility: Allergy Asthma Associates Research Dept.
state: Texas
city: Dallas,
country: United States
facility: Research Across America
state: Texas
city: Dallas
country: United States
facility: AARA 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: Waco
country: United States
facility: Allergy and Asthma Center
state: Texas
Study officials:
References: