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A Study to Evaluate the Safety & Effectiveness of a Nasal Spray to Treat Seasonal Allergies

Information source: Meda Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Seasonal Allergic Rhinitis

Intervention: Placebo nasal spray (Drug); 0.15% azelastine hydrochloride Nasal Spray (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Meda Pharmaceuticals

Official(s) and/or principal investigator(s):
Lewis M Fredane, MD, Study Director, Affiliation: Meda Pharmaceuticals

Summary

The Purpose of this study is to determine if one allergy medication (0. 15% azelastine hydrochloride) is more effective than Placebo alone

Clinical Details

Official title: Randomized, Double Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-036 in Patients With Seasonal Allergic Rhinitis

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

Primary outcome: Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined)at 14 Days

Secondary outcome:

Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (tNSS) (AM) for the Entire 14-day Study Period Compared to Placebo

Change From Baseline in 12 Hour Instantaneous Total Nasal Sytmptom Score (AM and PM Combined)at 14 Days

Change From Baseline in 12-hour Reflective SSCS for the Entire 14-day Study Period Compared to Placebo (Am and PM Combined)

Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at 14 Days

Change From Baseline on Direct Visual Nasal Exams at 14 Days

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Male and female patients 12 years of age and older with a 2 year history of moderate

to severe seasonal allergic rhinitis

- Must be in generally good health

- Must meet minimum symptom requirements, as specified in the protocol

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

procedures

- Positive skin test to a prevalent fall allergen

Exclusion Criteria:

- On focused Nasal Examination, the presence of any nasal mucosal erosion, nasal

ulceration, or nasal septal perforation at either the screening visit or randomization visit will disqualify the subject from the study.

- Other nasal disease(s)likely to affect deposition of intranasal medication, such as

sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.

- Nasal Surgery or sinus surgery within the previous year

- Chronic sinusitis-more than 3 episodes a year

- Planned travel outside of the study area during the study period

- The use of any investigational drug within 30 days prior to screening. No

investigational products are permitted for use during the conduct of the study.

- Presence of any hypersensitivity to drugs similar to azelastine and to either

sorbital or sucralose (Splenda brand sweetener)

- Women who are pregnant or nursing

- Women of childbearing potential who are not abstinent or not practicing medically

acceptable method of contraception

- Respiratory tract infection within 14 days prior to screening

- Respiratory tract infections requiring antibiotic treatment 14 days prior to

screening

- Asthma (with the exception of mild, intermittent asthma). Subjects with mild,

intermittent asthma who only require short-acting inhaled bronchodilators (not for more often tha twice a week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment

- Significant pulmonary disease including COPD

- Clinically significant arrythmia or symptomatic cardiac conditions

- A known history of alcohol or drug abuse within the last 2 years

- Existence of any surgical or medical condition or physical laboratory findings, which

in the opinion of the investigator or sponsor's medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug; that might significantly affect the subject's ability to complete this trial; or their safety in this trial

- Clinically relevant abnormal physical findings which, in the opinion of the

investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures.

Locations and Contacts

Allergy and Asthma Specialist Medical Group, Huntington Beach, California 92647, United States

Allergy, Asthma and Respiratory Care medical Center, Long Beach, California 90806, United States

Allergy and Asthma Medical Group and Research Center, San Diego, California 92123, United States

Allergy & Asthma Associates of Santa Clara Valley Research Cntr, San Jose, California 95117, United States

Bensch Research Associates, Stockton, California 95207, United States

Colorado Allergy and Asthma centers, PC, Lakewood, Colorado 80401, United States

University of South Florida, Tampa, Florida 33613, United States

Aeroallergy Research Laboratories of Savannah, Savannah, Georgia 31406, United States

Clinical Research Atlanta, Stockbridge, Georgia 30281, United States

Atlanta Allergy and Asthma Clinic, Woodstock, Georgia 30188, United States

Sneeze, Wheeze and Itch Associates, Normal, Illinois 61761, United States

Kansas City Allergy and Asthma, Overland Park, Kansas 66210, United States

RX R+D, Metairie, Louisiana 70001, United States

Chesapeake Clinical Research, Inc, Baltimore, Maryland 21236, United States

Institute for Asthma and Allergy PC, Wheaton, Maryland 20902, United States

Clinical Research Institute, Plymouth, Minnesota 55441, United States

The Clinical Research Center, St. Louis, Missouri 63141, United States

Midwest Allergy and Asthma Clinic, Omaha, Nebraska 68130, United States

The Asthma and Allergy Center, Papillion, Nebraska 68046, United States

Las Vegas Physicians Research Group, Henderson, Nevada 89052, United States

Allergy and Asthma Research NJ inc, Mount Laurel, New Jersey 08054, United States

Allergy Consultants PA, Verona, New Jersey 07044, United States

AAIR Research Center, Rochester, New York 14618, United States

OIAA Clinical Research, LLC, Edmond, Oklahoma 73003, United States

Asthma and Allergy Research Associates, Chester, Pennsylvania 19013, United States

Valley Clinical Research, Easton, Pennsylvania 18045, United States

UPMC-ENT, Pittsburgh, Pennsylvania 15213, United States

Asthma, Nasal Disease & Allergy Research Center of New England, Providence, Rhode Island 02906, United States

Jane Lee, MD, PA Research Center, Dallas, Texas 75246, United States

Pharmaceutical Research & Consulting Inc, Dallas, Texas 75231, United States

Western Sky Medical Research, El Paso, Texas 79902, United States

Allergy Asthma Research Institute, Waco, Texas 76712, United States

Advanced Healthcare, SC, Milwaukee, Wisconsin 53209, United States

Allergy and Asthma Center of Michigan, Novi, Wisconsin 48375, United States

Additional Information

Starting date: August 2007
Last updated: January 27, 2010

Page last updated: August 23, 2015

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