A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Children With Perennial Allergic Rhinitis

Perennial Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01018862
• Other study ID #: MP441
• Status: Completed
• Phase: Phase 3
• First received: November 24, 2009
• Last updated: May 10, 2012
• Start date: November 2009
• Est. completion date: April 2011

Study information

• Verified date: May 2012
• Source: Meda Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

in Children Ages >6 to <12 with Perennial Allergic Rhinitis (PAR)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 489
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• Azelastine hydrochloride nasal spray 0.15%
822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
• Azelastine hydrochloride nasal spray 0.10%
548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
• Placebo
0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks

Locations

Country	Name	City	State
United States	Clinical Research Atlanta	Atlanta	Georgia
United States	Isis Clinical Research, LLC	Ausitn	Texas
United States	Central Texas Clinical Research	Austin	Texas
United States	Sirius Clinical Research	Austin	Texas
United States	Chesapeake Clinical Research, Inc	Baltimore	Maryland
United States	Allergy and Asthma Consultants, LLP	Charleston	South Carolina
United States	Bernstein Clinical Research Center	Cincinnati	Ohio
United States	Allergy and Asthma Consultants of NJ-PA, P.C	Collegeville	Pennsylvania
United States	West Coast Clinical Trials	Costa Mesa	California
United States	Pharmaceutical Research & Consulting Inc	Dallas	Texas
United States	Colorado Allergy and Asthma Centers, PC	Denver	Colorado
United States	Intermountain Clinical Research	Draper	Utah
United States	Idaho Allergy	Eagle	Idaho
United States	Western Sky Medical Research	El Paso	Texas
United States	Gary Steven, MD	Greenfield	Wisconsin
United States	Clinical Research Institute of Indiana	Indianapolis	Indiana
United States	Baker Asthma, Allergy and Dermatology Research Center, LLC	Lake Oswego	Oregon
United States	Allergy, Asthma and Respiratory Care Center	Long Beach	California
United States	Southern California Research	Mission Viejo	California
United States	Sneeze, Wheeze and Itch Associates	Normal	Illinois
United States	Allergy, Asthma & Clinical Research Center	Oklahoma City	Oklahoma
United States	Oklahoma Institute of Allergy and Asthma	Oklahoma City	Oklahoma
United States	Joann Blessing-Moore,MD	Palo Alto	California
United States	Asthma and Allergy Center, PC	Papillion	Nebraska
United States	Clinical Research Institute	Plymouth	Minnesota
United States	Allergy Associated Research Center	Portland	Oregon
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	Island Medical Research	Rockville Center	New York
United States	Capital Allergy and Respiratory Disease Center	Sacramento	California
United States	Sylvana Research Associates	San Antonio	Texas
United States	Allergy and Asthma Medical Group and Research Center	San Diego	California
United States	Allergy & Asthma Associates of Santa Clara Valley Research Cntr	San Jose	California
United States	Princeton Center for Clinical Research	Skillman	New Jersey
United States	Marycliff Allergy Specialists	Spokane	Washington
United States	Bensch Research Associates	Stockton	California
United States	Toledo Center for Clinical Research	Sylvania	Ohio
United States	Asthma, Sinus & Allergy Centers, LLC	Warren	New Jersey
United States	Center for Allergy, Asthma and Immunology	Waterbury	Connecticut
United States	Respiratory Medicine Research Institute of Michigan	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Meda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) for the Entire 28-day Study Period Compared to Placebo	Change from baseline in 12-hour reflective total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms.	baseline to 28 Days	No
Secondary	Change From Baseline in the Instantaneous Total Nasal Symptoms Score (TNSS) for the Entire 28-day Study Period Compared to Placebo	change from baseline in 12-hour instantaneous total nasal symptom score (TNSS) for the entire 28-day study period compared to placebo,scored on a 0 to 24 scale with 0 being no symptoms and 24 being severe symptoms.	baseline to 28 days	No
Secondary	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	change from baseline in 12-hour instantaneous total ocular symptom score (TOSS) for the entire 28-day study period compared to placebo,scored on a 0 to 18 scale with 0 being no symptoms and 18 being severe symptoms.	baseline to 28 days	No
Secondary	Change From Baseline to Visit 4 in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Compared to Placebo	change from baseline in the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) compared to placebo for the entire 28-day study period compared to placebo,scored on a 0 to 42 scale with 0 being not troubled at all and 42 being extremely troublesome.	baseline to 28 Days	No