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

Seasonal Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719862
• Other study ID #: MP439
• Status: Completed
• Phase: Phase 3
• First received: July 21, 2008
• Last updated: January 27, 2010
• Start date: August 2007
• Est. completion date: November 2007

Study information

• Verified date: January 2010
• 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 medication (0.15% azelastine hydrochloride) is more effective than Placebo alone

Recruitment information / eligibility

• Status: Completed
• Enrollment: 481
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years and older

Eligibility

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.

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

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• Placebo nasal spray
Placebo
• 0.15% azelastine hydrochloride Nasal Spray
0.15% azelastine hydrochloride 822 mcg

Locations

Country	Name	City	State
United States	Chesapeake Clinical Research, Inc	Baltimore	Maryland
United States	Asthma and Allergy Research Associates	Chester	Pennsylvania
United States	Jane Lee, MD, PA Research Center	Dallas	Texas
United States	Pharmaceutical Research & Consulting Inc	Dallas	Texas
United States	Valley Clinical Research	Easton	Pennsylvania
United States	OIAA Clinical Research, LLC	Edmond	Oklahoma
United States	Western Sky Medical Research	El Paso	Texas
United States	Las Vegas Physicians Research Group	Henderson	Nevada
United States	Allergy and Asthma Specialist Medical Group	Huntington Beach	California
United States	Colorado Allergy and Asthma centers, PC	Lakewood	Colorado
United States	Allergy, Asthma and Respiratory Care medical Center	Long Beach	California
United States	RX R+D	Metairie	Louisiana
United States	Advanced Healthcare, SC	Milwaukee	Wisconsin
United States	Allergy and Asthma Research NJ inc	Mount Laurel	New Jersey
United States	Sneeze, Wheeze and Itch Associates	Normal	Illinois
United States	Allergy and Asthma Center of Michigan	Novi	Wisconsin
United States	Midwest Allergy and Asthma Clinic	Omaha	Nebraska
United States	Kansas City Allergy and Asthma	Overland Park	Kansas
United States	The Asthma and Allergy Center	Papillion	Nebraska
United States	UPMC-ENT	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	AAIR Research Center	Rochester	New York
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	Aeroallergy Research Laboratories of Savannah	Savannah	Georgia
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	University of South Florida	Tampa	Florida
United States	Allergy Consultants PA	Verona	New Jersey
United States	Allergy Asthma Research Institute	Waco	Texas
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 14 Days		baseline and 14 days	No
Secondary	Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (tNSS) (AM) for the Entire 14-day Study Period Compared to Placebo		baseline and 14 days	No
Secondary	Change From Baseline in 12 Hour Instantaneous Total Nasal Sytmptom Score (AM and PM Combined)at 14 Days		baseline and 14-days	No
Secondary	Change From Baseline in 12-hour Reflective SSCS for the Entire 14-day Study Period Compared to Placebo (Am and PM Combined)		baseline and 14-days	No
Secondary	Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at 14 Days		baseline and 14 Days	No
Secondary	Change From Baseline on Direct Visual Nasal Exams at 14 Days		baseline and 14 days	Yes