Overview

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

Status:
Completed
Trial end date:
2008-04-01
Target enrollment:
0
Participant gender:
All
Summary
The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Meda Pharmaceuticals
Treatments:
Azelastine
Criteria
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