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

NCT ID: NCT00660829

Last Updated: 2015-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 536 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

2

0.15% Azelastine Hydrochloride

Group Type: ACTIVE_COMPARATOR

0.15% Azelastine Hydrochloride

Intervention Type: DRUG

0.15% Azelastine Hydrochloride 822 mcg

Interventions

Placebo

Placebo

Intervention Type: DRUG

0.15% Azelastine Hydrochloride

0.15% Azelastine Hydrochloride 822 mcg

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meda Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lewis M Fredane, MD

Role: STUDY_DIRECTOR

Meda Pharmaceuticals

Locations

Allergy and Asthma Associates

Austin, Texas, United States

Allergy and Asthma Center of Austin

Austin, Texas, United States

Central Texas Research

New Braunfels, Texas, United States

Biogenics Research Institute

San Antonio, Texas, United States

Sylvana Research Associates

San Antonio, Texas, United States

Allergy and Asthma Center

Waco, Texas, United States

Countries

United States

Other Identifiers

MP440

Identifier Type: -

Identifier Source: org_study_id