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

Perennial Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00712920
• Other study ID #: MP434
• Status: Completed
• Phase: Phase 3
• First received: July 8, 2008
• Last updated: June 6, 2011
• Start date: January 2007

Study information

• Verified date: June 2011
• 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 two allergy medications are more effective than placebo.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 581
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

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:
• 0.15% azelastine hydrochloride
0.15% azelastine hydrochloride 1644 mcg
• 0.1% azelastine hydrochloride
0.1% azelastine hydrochloride 1096 mcg
• Placebo
Placebo

Locations

Country	Name	City	State
United States	Allergy and Asthma Associates	Austin	Texas
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	The William Storms Allergy Clinic	Colorodo Springs	Colorado
United States	AARA Research Center	Dallas	Texas
United States	Pharmaceutical Research & Consulting Inc	Dallas	Texas
United States	Las Vegas Physicians Research Group	Henderson	Nevada
United States	Allergy and Asthma Specialist Medical Group	Huntington Beach	California
United States	Allergy Asthma and Dermatology Research	Lake Oswego	Oregon
United States	Allergy, Asthma and Respiratory Care medical Center	Long Beach	California
United States	Allergy Research Foundation	Los Angeles	California
United States	Clinical Research Institute of Southern Oregon, PC	Medford	Oregon
United States	Advanced Healthcare, SC	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 Research	New Braunfels	Texas
United States	Sneeze, Wheeze and Itch Associates	Normal	Illinois
United States	Northeast Medical Research Associates	North Dartmouth	Massachusetts
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	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	Virginia Adult & Pediactric Allergy & Asthma, PC	Richmond	Virginia
United States	AAIR Research Center	Rochester	New York
United States	Biogenics Research Institute	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	Asthma, Inc.	Seattle	Washington
United States	The Clinical Research Center	St. Louis	Missouri
United States	Dr. Perin	Teaneck	New Jersey
United States	Asthma and Allergy Research Associate	Upland	Pennsylvania
United States	Allergy and Asthma Center	Waco	Texas
United States	Allergy and Asthma Clinical Research, Inc.	Walnut Creek	California
United States	Institute for Asthma and Allergy PC	Wheaton	Maryland
United States	Atlanta Allergy and Asthma Clinic	Woodstock	Georgia

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 (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.	baseline and 28 days	No
Secondary	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.	baseline and 28 days	No
Secondary	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.	baseline and 28 days	No
Secondary	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.	baseline and 28 Days	No
Secondary	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	baseline and 28 days	Yes