A Study to Evaluate the Safety and Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis

Perennial Allergic Rhinitis Clinical Trial

Official title:

Active Controlled Trial of the Safety and Tolerability of MP 03-036 (Astepro 0.15%) in Patients With Perennial Allergic Rhinitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00720382
• Other study ID #: MP436
• Status: Completed
• Phase: Phase 3
• First received: July 21, 2008
• Last updated: May 4, 2015
• Start date: March 2007
• Est. completion date: July 2008

Study information

• Verified date: May 2015
• 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 determine if one allergy treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 703
• Est. completion date: July 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Male and female patients 12 years and older with a compatible history greater than or equal to 1 year of rhinitis due to perennial allergies.

• Must be willing and able to provide informed consent and to participate in all study procedures

• Must be in generally good health

• Positive skin test to a prevalent perennial allergen

Exclusion Criteria:

• On nasal examination, the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation

• Use of any investigational drug within 30 days of the first visit

• Any nasal surgery or sinus surgery within the previous year

• Presence of any hypersensitivity to drugs similar to azelastine or mometasone furoate and to either sorbital or sucralose

• Women who are pregnant or nursing

• Women who are not using an acceptable method of birth control

• Nasal Diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities.

• Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with investigator.

• Patients with Arrythmia

• Patients with know history of alcohol and drug abuse

• Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of the study.

• Use of medications that could affect the study results

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• 0.15% azelastine hydrochloride
1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM
• Mometasone furoate
200 mcg (50 mcg/spray) 2 sprays per nostril Once a day (AM)

Locations

Country	Name	City	State
United States	Georgia Pollens Clinical Research Centers Inc	Albany	Georgia
United States	Allergy and Asthma Associates	Austin	Texas
United States	Allergy and Asthma Specialist PC	Blue Bell	Pennsylvania
United States	National Allergy, Asthma and Urticaria of Charleston	Charleston	South Carolina
United States	Bernstein Clinical Research Center	Cincinnati	Ohio
United States	New Horizon's Clinical Research	Cincinnati	Ohio
United States	Allergy and Consultants of NJ/PA	Collegeville	Pennsylvania
United States	Asthma and Allergy Associates	Colorado Springs	Colorado
United States	AARA Research Center	Dallas	Texas
United States	Pharmaceutical Research & Consulting Inc	Dallas	Texas
United States	Oklahoma Institute of Allergy and Asthma Clinical	Edmond	Oklahoma
United States	Western Sky Medical Research	El Paso	Texas
United States	AABI Associates Medical Group	Fountain Valley	California
United States	Las Vegas Physicians Research Group	Henderson	Nevada
United States	SWAAA Research Center	Houston	Texas
United States	Allergy and Asthma Specialist Medical Group	Huntington Beach	California
United States	Allergy Asthma and Dermatology Research	Lake Oswego	Oregon
United States	West Coast Clinical Trials	Long Beach	California
United States	Allergy Research Foundation	Los Angeles	California
United States	Clinical Research Institute of Southern Oregon, PC	Medford	Oregon
United States	RX R+D	Metairie	Louisiana
United States	Advanced Healthcare	Milwaukee	Wisconsin
United States	Clinical Research Institute	Minneapolis	Minnesota
United States	Southern California Research	Mission Viejo	California
United States	Allergy and Asthma Research NJ inc	Mount Laurel	New Jersey
United States	Central Texas Health Research	New Braunfels	Texas
United States	Sneeze, Wheeze and Itch Associates	Normal	Illinois
United States	Northeast Medical Research Associates	North Dartmouth	Massachusetts
United States	Medical Research Associates of CNY, PLLC	North Syracuse	New York
United States	Allergy and Asthma Care of Florida	Ocala	Florida
United States	Atlantic Research Center	Ocean	New Jersey
United States	Allergy, Asthma and Clinical Research Center	Oklahoma City	Oklahoma
United States	Kansas City Allergy and Asthma	Overland Park	Kansas
United States	Center of Research Excellence, LLC	Oxford	Alabama
United States	The Asthma and Allergy Center	Papillion	Nebraska
United States	Allergy and Clinical Immunology Associates	Pittsburgh	Pennsylvania
United States	Clinical Research Institute	Plymouth	Minnesota
United States	Asthma, Nasal Disease & Allergy Research Center of New England	Providence	Rhode Island
United States	North Carolina Clinical Research	Raleigh	North Carolina
United States	Wake Research Associates, LLC	Raleigh	North Carolina
United States	VA Adult and Pediatric Allergy and Asthma	Richmond	Virginia
United States	AAIR Research Center	Rochester	New York
United States	Biogenics Research Institute	San Antonio	Texas
United States	Live Oak Allergy and Asthma Clinic	San Antonio	Texas
United States	Sylvana Research Associates	San Antonio	Texas
United States	Allergy and Asthma Medical Group and Research Center	San Diego	California
United States	Allergy Associates Medical Group Inc	San Diego	California
United States	Allergy & Asthma Associates of Santa Clara Valley Research Cntr	San Jose	California
United States	Aeroallergy Research Laboratories of Savannah	Savannah	Georgia
United States	Asthma, Inc.	Seattle	Washington
United States	The Clinical Research Center	St. Louis	Missouri
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Bensch Research Associates	Stockton	California
United States	Allergy and Asthma DTC	Tallahassee	Florida
United States	Dr. Perin	Teaneck	New Jersey
United States	Asthma and Allergy Research Associate	Upland	Pennsylvania
United States	Allergy Asthma Research Institute	Waco	Texas
United States	Allergy and Asthma Clinical Research, Inc.	Walnut Creek	California
United States	Institute for Asthma and Allergy PC	Wheaton	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Meda Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline to 12 Months in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older	A 28-item RQLQ was completed on Day 1, Month 1, Month 3, Month 6, month 9 and month 12 or Early termination. 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 to 12 months	No
Primary	Change From Baseline on Direct Visual Nasal Exams to 12 Months	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 irritation 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	Change from baseline to 12 months	Yes