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

Condition(s) targeted: Seasonal Allergic Rhinitis

Intervention: Placebo (Drug); azelastine hydrochloride (Drug); fluticasone propionate (Drug); azelastine hydrochloride/fluticasone propionate (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 two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)

Official title: Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Astelin Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Change from baseline in 12 hour reflective total nasal symptom score

Secondary outcome:

Change from baseline in 12 hour instantaneous total nasal symptom score

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

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

Criteria:

Inclusion Criteria:

- Male and female subjects 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 (Grade 1b - 4) 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 Day screening. No

investigational products are permitted for use during the conduct of this study

- Presence of any hypersensitivity to drugs similar to azelastine hydrochloride or

fluticasone propionate

- Women who are pregnant or nursing

- Women of childbearing potential who are not abstinent or not practicing a medically

acceptable method of contraception* see section 6. 1.1

- Respiratory Tract Infections within 14 days prior to Day 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 within 1 week of randomization which,

in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures

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

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

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

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

Allergy and Asthma Care, Waco, Texas 76708, United States

Southwest Allergy and Asthma Center, P.A., San Antonio, Texas 78229, United States

Allergy, Asthma Research Center, San Antonio, Texas 78258, United States

Starting date: December 2007
Ending date: April 2008
Last updated: April 16, 2008