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

Information source: Meda Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Seasonal Allergic Rhinitis

Intervention: Placebo (Drug); 0.15% Azelastine Hydrochloride (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Meda Pharmaceuticals

Official(s) and/or principal investigator(s):
Lewis M Fredane, MD, Study Director, Affiliation: Meda Pharmaceuticals


The Purpose of this study is to determine if one allergy medication (0. 15% azelastine hydrochloride) is more effective than Placebo alone.

Clinical Details

Official title: Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 in Subjects With Seasonal Allergic Rhinitis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (TNSS) (AM and PM Combined)at 14 Days

Secondary outcome:

Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (AM) for the Entire 14-day Study Period Compared to Placebo.

Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (AM and PM Combined) at 14 Days

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)

Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)

Change From Baseline on Direct Visual Nasal Exams at 14 Days


Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.


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


- 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


- 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

Locations and Contacts

Allergy and Asthma Associates, Austin, Texas 78731, United States

Allergy and Asthma Center of Austin, Austin, Texas 78759, United States

Central Texas Research, New Braunfels, Texas 78130, United States

Biogenics Research Institute, San Antonio, Texas 78229, United States

Sylvana Research Associates, San Antonio, Texas 78229, United States

Allergy and Asthma Center, Waco, Texas 76712, United States

Additional Information

Starting date: December 2007
Last updated: April 9, 2015

Page last updated: August 23, 2015

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