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

NCT00719862 | Completed Phase 3 Results

• 1 other identifier: MP439
• Study Type: interventional
• Target: 481
• Locations: 1 country
• Sites: 34

Brief Summary

The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined)at 14 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 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 14 days

Secondary Outcomes (5)

• 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

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

  baseline and 14-days

• 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

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

  baseline and 14 Days

• Change From Baseline on Direct Visual Nasal Exams at 14 Days

  baseline and 14 days

Study Arms (2)

Placebo Nasal Spray

PLACEBO COMPARATOR

0mg Placebo Nasal Spray

Drug: Placebo nasal spray

0.15% azelastine hydrochloride nasal spray

ACTIVE COMPARATOR

0.15% azelastine hydrochloride

Drug: 0.15% azelastine hydrochloride Nasal Spray

Interventions

Placebo nasal spray DRUG

Placebo

Placebo Nasal Spray

0.15% azelastine hydrochloride Nasal Spray DRUG

0.15% azelastine hydrochloride 822 mcg

Also known as: astepro 0.15%

0.15% azelastine hydrochloride nasal spray

Eligibility Criteria

• Age: 12 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meda Pharmaceuticals: lead

Study Sites (34)

Allergy and Asthma Specialist Medical Group

Huntington Beach, California, 92647, United States

Location

Allergy, Asthma and Respiratory Care medical Center

Long Beach, California, 90806, United States

Location

Allergy and Asthma Medical Group and Research Center

San Diego, California, 92123, United States

Location

Allergy & Asthma Associates of Santa Clara Valley Research Cntr

San Jose, California, 95117, United States

Location

Bensch Research Associates

Stockton, California, 95207, United States

Location

Colorado Allergy and Asthma centers, PC

Lakewood, Colorado, 80401, United States

Location

University of South Florida

Tampa, Florida, 33613, United States

Location

Aeroallergy Research Laboratories of Savannah

Savannah, Georgia, 31406, United States

Location

Clinical Research Atlanta

Stockbridge, Georgia, 30281, United States

Location

Atlanta Allergy and Asthma Clinic

Woodstock, Georgia, 30188, United States

Location

Sneeze, Wheeze and Itch Associates

Normal, Illinois, 61761, United States

Location

Kansas City Allergy and Asthma

Overland Park, Kansas, 66210, United States

Location

RX R+D

Metairie, Louisiana, 70001, United States

Location

Chesapeake Clinical Research, Inc

Baltimore, Maryland, 21236, United States

Location

Institute for Asthma and Allergy PC

Wheaton, Maryland, 20902, United States

Location

Clinical Research Institute

Plymouth, Minnesota, 55441, United States

Location

The Clinical Research Center

St Louis, Missouri, 63141, United States

Location

Midwest Allergy and Asthma Clinic

Omaha, Nebraska, 68130, United States

Location

The Asthma and Allergy Center

Papillion, Nebraska, 68046, United States

Location

Las Vegas Physicians Research Group

Henderson, Nevada, 89052, United States

Location

Allergy and Asthma Research NJ inc

Mount Laurel, New Jersey, 08054, United States

Location

Allergy Consultants PA

Verona, New Jersey, 07044, United States

Location

AAIR Research Center

Rochester, New York, 14618, United States

Location

OIAA Clinical Research, LLC

Edmond, Oklahoma, 73003, United States

Location

Asthma and Allergy Research Associates

Chester, Pennsylvania, 19013, United States

Location

Valley Clinical Research

Easton, Pennsylvania, 18045, United States

Location

UPMC-ENT

Pittsburgh, Pennsylvania, 15213, United States

Location

Asthma, Nasal Disease & Allergy Research Center of New England

Providence, Rhode Island, 02906, United States

Location

Pharmaceutical Research & Consulting Inc

Dallas, Texas, 75231, United States

Location

Jane Lee, MD, PA Research Center

Dallas, Texas, 75246, United States

Location

Western Sky Medical Research

El Paso, Texas, 79902, United States

Location

Allergy Asthma Research Institute

Waco, Texas, 76712, United States

Location

Advanced Healthcare, SC

Milwaukee, Wisconsin, 53209, United States

Location

Allergy and Asthma Center of Michigan

Novi, Wisconsin, 48375, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: William Wheeler, PhD
• Organization: Meda Pharmaceuticals

WWheeler@medapharma.us

732-564-2351

Study Officials

• Lewis M Fredane, MD

  Meda Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 21, 2008
• First Posted: July 22, 2008
• Study Start: August 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: February 2, 2010
• Results First Posted: January 28, 2010

Record last verified: 2010-01

Locations

US (34)