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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01018862
Other study ID # MP441
Secondary ID
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


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
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