Clinical trial NCT01018862: A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Children With Perennial Allergic Rhinitis
Official title: Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 (0.15% Solution) and MP03-33 (0.10% Solution) in Children Ages >6 to <12 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: 2009-11-25
Enrollment: 489
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of an Investigational use of an allergy medication (MP03-33) used to treat perennial allergic rhinitis (PAR) to placebo (a nasal spray that contains no medicine). In addition, the study will also compare the safety and effectiveness of an investigational use of another allergy medication (MP03-36) used to treat perennial allergic rhinitis to placebo.

Detailed description: in Children Ages \>6 to \<12 with Perennial Allergic Rhinitis (PAR)

Eligibility criteria: Inclusion Criteria:

* Male and female subjects \>6-\<12, inclusive at the screening visit
* At least a 1-year history of PAR
* The parent must provide written informed consent and the child must provide written assent.
* Willing and able to comply with the study requirements
* The presence of immunoglobulin E (IgE)-mediated hypersensitivity to dust mite, cockroach, mold, cat or dog dander, confirmed by a positive response to skin prick testing at the Visit 1. A positive response is defined as a wheal diameter of ≥5 mm larger than the negative control for the skin prick test. Histamine control must also be positive with a wheal diameter \>5 mm larger than the control. If there are prevailing seasonal allergies, the subject must have a negative skin test to the specific allergen.
* Screening Visit: Have a 12-hour reflective TNSS of at least 6 out of a possible 12 and a congestion score of ≥2 or a rhinorrhea score of ≥2 on Visit 1
* Randomization Visit: to be eligible for entry into the double-blind treatment period, subjects/caregivers must record:

  1. at least 3 symptom assessments (either AM or PM score) during the past 3 days of the Lead-In Period or the Day of Randomization:

     1. a 12-hour reflective TNSS ≥ 6
     2. a 12-hour reflective congestion score of ≥2 or a rhinorrhea score of ≥2
  2. the total of the seven Lead-In symptom assessments during the past 3 days of the Lead-In Period including the Day of Randomization (Visit 2/Day 1):

     1. a 12-hour reflective TNSS ≥ 42
     2. a 12-hour reflective congestion score of ≥14 or a rhinorrhea score of ≥14
* Must have taken at least 10 doses of study medication during the placebo Lead-In Period
* 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
* Subjects 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 do not preclude participation). Subjects receiving sublingual immunotherapy are excluded. A 6 month washout period is required following the last dose of sublingual immunotherapy.

Exclusion Criteria:

* On nasal examination, subjects with superficial nasal mucosal erosion, moderate nasal mucosal erosion, nasal mucosal ulceration, nasal septum perforation (Grade 1B - 4) (see section 8.1.4).
* Other nasal disease(s) likely to affect deposition of intranasal medication, such as acute sinusitis, rhinitis medicamentosa or clinically significant polyposis or nasal structural abnormalities.
* Nasal surgery or sinus surgery within the previous year.
* Chronic sinusitis
* The use of any investigational drug within 30 days prior to Visit 1. 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)
* Females who are pregnant or nursing
* Females of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception
* Respiratory tract infections within two weeks prior to Visit 1
* Subjects with significant pulmonary disease including asthma. Subjects with intermittent asthma who only require short-acting inhaled bronchodilators are eligible for enrollment.
* Chronic obstructive sleep apnea syndrome (clinical diagnosis)
* Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor's medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug or that might significantly affect the subject's ability to complete this trial.
* 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
* Overnight absences from home for more than 3 nights
* Family members of research center or private practice personnel who are directly involved in this study are excluded
* Members of the same family cannot enroll in the study at the same time
* Subjects who have used the medications or therapies that could interfere with symptom evaluation within the time period specified (see Section 4.0).
* Any behavioral condition which could affect subject's ability to accurately report symptoms to the caregiver such as developmental delay, attention deficit disorder, and autism

Primary outcomes:
measure: Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) for the Entire 28-day Study Period Compared to Placebo
timeFrame: baseline to 28 Days
Secondary outcomes:
measure: Change From Baseline in the Instantaneous Total Nasal Symptoms Score (TNSS) for the Entire 28-day Study Period Compared to Placebo
timeFrame: baseline to 28 days
measure: Change From Baseline in 12-hour Reflective Total Ocular Symptoms Score (TOSS) and Instantaneous Total Ocular Symptoms Score (TOSS) for the Entire 28-day Study Period Compared to Placebo
timeFrame: baseline to 28 days
measure: Change From Baseline to Visit 4 in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Compared to Placebo
timeFrame: baseline to 28 Days
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: West Coast Clinical Trials
state: California
city: Long Beach
country: United States
facility: Allergy, Asthma and Respiratory Care Center
state: California
city: Mission Viejo
country: United States
facility: Southern California Research
state: California
city: Palo Alto
country: United States
facility: Joann Blessing-Moore,MD
state: California
city: Sacramento
country: United States
facility: Capital Allergy and Respiratory Disease 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: Denver
country: United States
facility: Colorado Allergy and Asthma Centers, PC
state: Colorado
city: Waterbury
country: United States
facility: Center for Allergy, Asthma and Immunology
state: Connecticut
city: Atlanta
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Eagle
country: United States
facility: Idaho Allergy
state: Idaho
city: Normal
country: United States
facility: Sneeze, Wheeze and Itch Associates
state: Illinois
city: Indianapolis
country: United States
facility: Clinical Research Institute of Indiana
state: Indiana
city: Baltimore
country: United States
facility: Chesapeake Clinical Research, Inc
state: Maryland
city: Ypsilanti
country: United States
facility: Respiratory Medicine Research Institute of Michigan
state: Michigan
city: Plymouth
country: United States
facility: Clinical Research Institute
state: Minnesota
city: Papillion
country: United States
facility: Asthma and Allergy Center, PC
state: Nebraska
city: Skillman
country: United States
facility: Princeton Center for Clinical Research
state: New Jersey
city: Warren
country: United States
facility: Asthma, Sinus & Allergy Centers, LLC
state: New Jersey
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: Sylvania
country: United States
facility: Toledo Center for Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Allergy, Asthma & Clinical Research Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Institute of Allergy and Asthma
state: Oklahoma
city: Lake Oswego
country: United States
facility: Baker Asthma, Allergy and Dermatology Research Center, LLC
state: Oregon
city: Portland
country: United States
facility: Allergy Associated Research Center
state: Oregon
city: Collegeville
country: United States
facility: Allergy and Asthma Consultants of NJ-PA, P.C
state: Pennsylvania
city: Charleston
country: United States
facility: Allergy and Asthma Consultants, LLP
state: South Carolina
city: Ausitn
country: United States
facility: Isis Clinical Research, LLC
state: Texas
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: Austin
country: United States
facility: Sirius Clinical Research
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: San Antonio
country: United States
facility: Sylvana Research Associates
state: Texas
city: Draper
country: United States
facility: Intermountain Clinical Research
state: Utah
city: Spokane
country: United States
facility: Marycliff Allergy Specialists
state: Washington
city: Greenfield
country: United States
facility: Gary Steven, MD
state: Wisconsin
Study officials:
affiliation: Meda Phamaceuticals, Sr.Dir Medical and Scientific Affairs
name: David Ginsberg, DO
role: STUDY_DIRECTOR
References: