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

Meda Pharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Seasonal Allergic Rhinitis

Treatments

Drug: 0.15% Azelastine Hydrochloride

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00660829

MP440

Details and patient eligibility

About

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

Enrollment

536 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

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