A Study to Evaluate the Safety and Efficacy of Two Nasal Sprays to Treat Seasonal Allergies

Phase 3

Completed

Conditions: Seasonal Allergic Rhinitis

Interventions: Drug: Placebo
Drug: 0.1% azelastine hydrochloride 1096 mcg daily
Drug: 0.15% azelastine hydrochloride 1644 mcg daily

Registration Number: NCT00720278

Lead Sponsor: Meda Pharmaceuticals

Brief Summary: The purpose of this study was to determine if two allergy medications are more effective than placebo.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 526

Inclusion Criteria

Male and female patients 12 years of age and older
Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent
Screening Visit: Have a 12-hour reflective TNSS of at least 8 out of a possible 12 and a congestion score of 2 or 3 on Day -7
Randomization Visit: Have a 12-hour reflective TNSS (AM or PM) of at least 8 on 3 separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) during the Lead-in Period. In addition, an AM or PM 12-hour reflective nasal congestion score of 2 or 3 must have been recorded on 3 separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1)
Randomization Visit: An instantaneous TNSS of ≥ 8 before beginning the onset of action assessment on Day 1
Must have taken at least 10 doses of study medication during the lead-in period
Willing and able to comply with the study requirements
At least a 2-year history of SAR
The presence of IgE-mediated hypersensitivity to ragweed antigen or other local fall allergens, confirmed by a positive response to either skin prick within the last year. A positive response is defined as a wheal diameter of at least 3 mm larger than the negative control for the skin prick test.
General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor's medical officer. When in doubt, the investigator should confer with the sponsor's medical monitor or designee to determine eligibility for the study.
Patients receiving immunotherapy injections (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit (adjustments to regimen following a brief period of missed injections does not preclude participation). Patients currently receiving sublingual immunotherapy are excluded. A 6-month washout period is required following the last dose of sublingual immunotherapy.

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 patient from the study.
Other nasal disease(s) likely 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 per year
Planned travel outside of the study area during the study period
The use of any investigational drug within 30 days prior to Day -7. No investigational products are permitted for use during the conduct of this study
Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
Women who are pregnant or nursing
Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception
Respiratory Tract Infections within 14 days prior to Day -7
Respiratory Tract Infections requiring oral antibiotic within 14 days of Day -7
Asthma (with the exception of mild, intermittent asthma). Patients with mild, intermittent asthma who only require short-acting inhaled bronchodilators are eligible for enrollment.
Significant pulmonary disease including COPD
Clinically significant arrhythmia or with symptomatic cardiac conditions
A known history of alcohol or drug abuse
Existence of any surgical or medical condition or physical or 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 or that might significantly affect the patient's ability to complete this trial.
Clinically relevant abnormal physical findings within 1 week of randomization which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures
Participation in MedPointe Protocols MP433, MP434, MP435, or MP436.
Employees of the research center or private practice and their family members are excluded
Patients who received prohibited medications within specified timepoints in the protocol.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Nasal Spray	Placebo	Placebo nasal spray
Astepro 0.1%	0.1% azelastine hydrochloride 1096 mcg daily	0.1% azelastine hydrochloride nasal spray
Astepro 0.15%	0.15% azelastine hydrochloride 1644 mcg daily	0.15% azelastine hydrochloride nasal spray

Primary Outcome Measures

Name	Time	Method
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo	baseline and 14 days	rTNSS 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. (maximum 12 points per assessment.) 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 baseline as a covariate.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo	baseline and 14 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. 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.
Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo	baseline and 14 days	Reflective secondary symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headache) 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. 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.
Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older	baseline and 14 days	A 28-item RQLQ was completed on Day 1 and Day 14 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.
Change From Baseline on Direct Visual Nasal Exams	14 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

Trial Locations

Locations (29): Atlantic Research Center
🇺🇸
Ocean, New Jersey, United States
Research Asthma, Sinus and Allergy Centers
🇺🇸
Warren, New Jersey, United States
National Allergy, Asthma and Urticaria of Charleston
🇺🇸
Charleston, South Carolina, United States
Allergy Research Foundation
🇺🇸
Los Angeles, California, United States
Biogenics Research Institute
🇺🇸
San Antonio, Texas, United States
Clinical Research Center
🇺🇸
Encinitas, California, United States
Southern California Research
🇺🇸
Mission Viejo, California, United States
AAIR Research Center
🇺🇸
Rochester, New York, United States
Allergy, Asthma and Clinical Research Center
🇺🇸
Oklahoma City, Oklahoma, United States
Northeast Medical Research Associates
🇺🇸
North Dartmouth, Massachusetts, United States
Allergy Associates Medical Group Inc
🇺🇸
San Diego, California, United States
Bernstein Clinical Research Center
🇺🇸
Cincinnati, Ohio, United States
Center of Research Excellence, LLC
🇺🇸
Oxford, Alabama, United States
ENTA Allergy, Head and Neck Associates
🇺🇸
Decatur, Illinois, United States
North Carolina Clinical Research
🇺🇸
Raleigh, North Carolina, United States
Central Texas Health Research
🇺🇸
New Braunfels, Texas, United States
Colorado Allergy and Asthma Centers
🇺🇸
Denver, Colorado, United States
Sneeze, Wheeze and Itch Associates
🇺🇸
Normal, Illinois, United States
Allergy and Asthma Associates
🇺🇸
Austin, Texas, United States
Family Allergy and Asthma Reserach
🇺🇸
Louisville, Kentucky, United States
Storms Clinical Research Institute
🇺🇸
Colorado Springs, Colorado, United States
Allergy, Asthma and Immunology Associates
🇺🇸
Lincoln, Nebraska, United States
Allergy and Consultants of NJ/PA
🇺🇸
Collegeville, Pennsylvania, United States
Princeton Center for Clinical Research
🇺🇸
Skillman, New Jersey, United States
Allergy and Clinical Immunology Associates
🇺🇸
Pittsburgh, Pennsylvania, United States
Sylvana Research Associates
🇺🇸
San Antonio, Texas, United States
Allergy and Asthma Care
🇺🇸
Waco, Texas, United States
East Tennesse Center for Clinical Research
🇺🇸
Knoxville, Tennessee, United States
Clinical Research Institute
🇺🇸
Plymouth, Minnesota, United States