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

Phase 3

Completed

Conditions: Seasonal Allergic Rhinitis

Interventions: Drug: Placebo
Drug: 0.15% Azelastine Hydrochloride

Registration Number: NCT00660829

Lead Sponsor: Meda Pharmaceuticals

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 536

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 Texas Mountain Cedar 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 per 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 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 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 more often than twice per week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment
Significant pulmonary disease including COPD
Clinically significant arrhythmia 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 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; 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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo	Placebo
2	0.15% Azelastine Hydrochloride	0.15% Azelastine Hydrochloride

Primary Outcome Measures

Name	Time	Method
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) (AM and PM Combined)at 14 Days	baseline and 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 Means Square 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 co-variate

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score (SSCS) for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)	baseline and 14-days	Reflective secondary complex 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 Means Square 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 co-variate
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)	baseline and 14 Days	A 28-item RQLQ was completed on Day 1 and Day 14 or Early termination. 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. Scores for a series of subscales are not combined for a total overall score, rather 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 at 14 Days	baseline and 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 irritation 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
Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (AM) for the Entire 14-day Study Period Compared to Placebo.	baseline and 14 days	End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous (tNSS) for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous (tNSS) consists of runny nose, itchy nose, nasal congestion, and sneezing. 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 baseline as a covariate.
Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (AM and PM Combined) at 14 Days	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 Means Square 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 co-variate

Trial Locations

Locations (6): Allergy and Asthma Associates
🇺🇸
Austin, Texas, United States
Central Texas Research
🇺🇸
New Braunfels, Texas, United States
Sylvana Research Associates
🇺🇸
San Antonio, Texas, United States
Biogenics Research Institute
🇺🇸
San Antonio, Texas, United States
Allergy and Asthma Center
🇺🇸
Waco, Texas, United States
Allergy and Asthma Center of Austin
🇺🇸
Austin, Texas, United States