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A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergies

Primary Purpose

Perennial Allergic Rhinitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
0.15% azelastine hydrochloride
0.1% azelastine hydrochloride
Placebo
Sponsored by
Meda Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perennial Allergic Rhinitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female patients 12 years of age and older
  • Must be in generally good health
  • Must meet minimum symptom requirements, as specified in protocol
  • Must be willing and able to provide informed consent and participate in all study procedures
  • 2-year history of PAR
  • Positive skin test to cockroach, dust mite, mold or cat/dog dander

Exclusion Criteria:

  • On nasal examination, presence of any nasal mucosal erosion, nasal ulceration or nasal septal perforation at the screening or randomization visit
  • Nasal diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, significant polyposis or nasal structural abnormalities
  • Nasal surgery or sinus surgery within the previous year
  • The use of any investigational drug within 30 days
  • Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose
  • Women who are pregnant or nursing
  • Women of child-bearing potential who are not abstinent and not practicing a medically acceptable method of contraception
  • Respiratory tract infection within 2 weeks of screening
  • Respiratory tract infections requiring oral antibiotic treatment within 2 weeks of screening
  • Patients with asthma with the exception of mild, intermittent
  • Significant pulmonary disease including COPD
  • Patients with arrhythmia
  • 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 may significantly alter the absorption, distribution, metabolism or excretion of study drug.
  • Clinically relevant abnormal physical findings within one week of randomization
  • Overnight abscences from home for more than 3 nights
  • Employees of the research center or private practice and family members are excluded
  • Patients who received prohibited medications within specified timepoints in protocol.

Sites / Locations

  • Allergy and Asthma Specialist Medical Group
  • Allergy, Asthma and Respiratory Care medical Center
  • Allergy Research Foundation
  • Southern California Research
  • Allergy Associates Medical Group Inc
  • Allergy and Asthma Medical Group and Research Center
  • Allergy and Asthma Clinical Research, Inc.
  • Asthma and Allergy Associates
  • The William Storms Allergy Clinic
  • Atlanta Allergy and Asthma Clinic
  • Sneeze, Wheeze and Itch Associates
  • Kansas City Allergy and Asthma
  • Institute for Asthma and Allergy PC
  • Northeast Medical Research Associates
  • Clinical Research Institute
  • Clinical Research Institute
  • The Clinical Research Center
  • Las Vegas Physicians Research Group
  • Allergy and Asthma Research NJ inc
  • Atlantic Research Center
  • Dr. Perin
  • AAIR Research Center
  • North Carolina Clinical Research
  • Wake Research Associates, LLC
  • Bernstein Clinical Research Center
  • New Horizon's Clinical Research
  • Allergy, Asthma and Clinical Research Center
  • Allergy Asthma and Dermatology Research
  • Clinical Research Institute of Southern Oregon, PC
  • Allergy and Consultants of NJ/PA
  • Asthma and Allergy Research Associate
  • Asthma, Nasal Disease & Allergy Research Center of New England
  • National Allergy, Asthma and Urticaria of Charleston
  • Allergy and Asthma Associates
  • AARA Research Center
  • Pharmaceutical Research & Consulting Inc
  • Central Texas Research
  • Biogenics Research Institute
  • Sylvana Research Associates
  • Allergy and Asthma Center
  • Virginia Adult & Pediactric Allergy & Asthma, PC
  • Asthma, Inc.
  • Advanced Healthcare, SC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Placebo

0.15% azelastine hydrochloride 1644 mcg/2 sprays per nostril 2 times a day for 4 weeks

0.1% azelastine hydrochloride 1096 mcg/2 sprays per nostril 2 times a day for 4 weeks

Outcomes

Primary Outcome Measures

Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.
Reflective total nasal symptom score consisting of Runny nose, itchy nose, nasal Congestion, and Sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day Least square means (LS Mean) was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.

Secondary Outcome Measures

Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days
instantaneous (subjects rate how they feel "right now") total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.
Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days
Reflective secondary symptom complex scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.
Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days
A 28-item RQLQ was completed on Day 1 and Day 28 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation

Full Information

First Posted
July 8, 2008
Last Updated
June 6, 2011
Sponsor
Meda Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00712920
Brief Title
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergies
Official Title
Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 and MP03-33 in Patients With Perennial Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Meda Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if two allergy medications are more effective than placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perennial Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
581 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
2
Arm Type
Experimental
Arm Description
0.15% azelastine hydrochloride 1644 mcg/2 sprays per nostril 2 times a day for 4 weeks
Arm Title
3
Arm Type
Experimental
Arm Description
0.1% azelastine hydrochloride 1096 mcg/2 sprays per nostril 2 times a day for 4 weeks
Intervention Type
Drug
Intervention Name(s)
0.15% azelastine hydrochloride
Intervention Description
0.15% azelastine hydrochloride 1644 mcg
Intervention Type
Drug
Intervention Name(s)
0.1% azelastine hydrochloride
Intervention Description
0.1% azelastine hydrochloride 1096 mcg
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.
Description
Reflective total nasal symptom score consisting of Runny nose, itchy nose, nasal Congestion, and Sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day Least square means (LS Mean) was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.
Time Frame
baseline and 28 days
Secondary Outcome Measure Information:
Title
Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days
Description
instantaneous (subjects rate how they feel "right now") total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.
Time Frame
baseline and 28 days
Title
Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days
Description
Reflective secondary symptom complex scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.
Time Frame
baseline and 28 days
Title
Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days
Description
A 28-item RQLQ was completed on Day 1 and Day 28 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.
Time Frame
baseline and 28 Days
Title
Change From Baseline on Direct Visual Nasal Exams and 28 Days
Description
Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation
Time Frame
baseline and 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients 12 years of age and older Must be in generally good health Must meet minimum symptom requirements, as specified in protocol Must be willing and able to provide informed consent and participate in all study procedures 2-year history of PAR Positive skin test to cockroach, dust mite, mold or cat/dog dander Exclusion Criteria: On nasal examination, presence of any nasal mucosal erosion, nasal ulceration or nasal septal perforation at the screening or randomization visit Nasal diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, significant polyposis or nasal structural abnormalities Nasal surgery or sinus surgery within the previous year The use of any investigational drug within 30 days Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose Women who are pregnant or nursing Women of child-bearing potential who are not abstinent and not practicing a medically acceptable method of contraception Respiratory tract infection within 2 weeks of screening Respiratory tract infections requiring oral antibiotic treatment within 2 weeks of screening Patients with asthma with the exception of mild, intermittent Significant pulmonary disease including COPD Patients with arrhythmia 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 may significantly alter the absorption, distribution, metabolism or excretion of study drug. Clinically relevant abnormal physical findings within one week of randomization Overnight abscences from home for more than 3 nights Employees of the research center or private practice and family members are excluded Patients who received prohibited medications within specified timepoints in protocol.
Facility Information:
Facility Name
Allergy and Asthma Specialist Medical Group
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Allergy, Asthma and Respiratory Care medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Allergy Research Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Southern California Research
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Allergy Associates Medical Group Inc
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Allergy and Asthma Medical Group and Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Allergy and Asthma Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Asthma and Allergy Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
The William Storms Allergy Clinic
City
Colorodo Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Atlanta Allergy and Asthma Clinic
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30188
Country
United States
Facility Name
Sneeze, Wheeze and Itch Associates
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Kansas City Allergy and Asthma
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Institute for Asthma and Allergy PC
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Northeast Medical Research Associates
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Clinical Research Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Clinical Research Institute
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
The Clinical Research Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Las Vegas Physicians Research Group
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Allergy and Asthma Research NJ inc
City
Mount Laurel
State/Province
New Jersey
ZIP/Postal Code
08054
Country
United States
Facility Name
Atlantic Research Center
City
Ocean
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Dr. Perin
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
AAIR Research Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
North Carolina Clinical Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Bernstein Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
New Horizon's Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45252
Country
United States
Facility Name
Allergy, Asthma and Clinical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Allergy Asthma and Dermatology Research
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Clinical Research Institute of Southern Oregon, PC
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Allergy and Consultants of NJ/PA
City
Collegeville
State/Province
Pennsylvania
ZIP/Postal Code
19426
Country
United States
Facility Name
Asthma and Allergy Research Associate
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
Asthma, Nasal Disease & Allergy Research Center of New England
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
National Allergy, Asthma and Urticaria of Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Allergy and Asthma Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
AARA Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Pharmaceutical Research & Consulting Inc
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Central Texas Research
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Biogenics Research Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Sylvana Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Allergy and Asthma Center
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Virginia Adult & Pediactric Allergy & Asthma, PC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Asthma, Inc.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Advanced Healthcare, SC
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergies

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