The purpose of this study is to compare the safety and efficacy of an investigational nasal spray with placebo. This study can last up to six weeks. Subjects will need to visit the clinic up to six times. Clinic visits could include physical examinations, medical history review, nasal examinations, vital sign assessments, clinical laboratory evaluations, ECGs and allergy skin testing. You will need to complete daily symptom assessment diary cards during your study participation.

Condition	Treatment or Intervention	Phase
Perennial Allergic Rhinitis	Drug: Investigational rhinitis nasal spray	Phase III

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

• Diagnosis of perennial allergic rhinitis.
• Must comply with study procedures and be literate.

Exclusion criteria:

• Significant concomitant medical conditions.
• Use of corticosteroids.
• Use of allergy medications and some other medications during the study.
• Current tobacco use.
• Clinically significant abnormal ECG or laboratory abnormality.

Arizona
      Little Rock,  Arizona,  72205,  United States
California
      Los Angeles,  California,  90025,  United States
      San Diego,  California,  92120,  United States
      San Diego,  California,  92123,  United States
      Mission Viejo,  California,  92691,  United States
      Orange County,  California,  92868,  United States
Colorado
      Colorado Springs,  Colorado,  80907,  United States
Florida
      Tallahassee,  Florida,  32308,  United States
      Vero Beach,  Florida,  32960,  United States
      Miami,  Florida,  33173,  United States
      Miami,  Florida,  33176,  United States
      Tampa,  Florida,  33613,  United States
Georgia
      Lawrenceville,  Georgia,  30045,  United States
      Lilburn,  Georgia,  30047,  United States
Indiana
      South Bend,  Indiana,  46617,  United States
Louisiana
      Metairie,  Louisiana,  70006,  United States
Maine
      Portland,  Maine,  04102,  United States
Maryland
      Rockville,  Maryland,  20850,  United States
      Baltimore,  Maryland,  21236,  United States
Massachusetts
      Springfield,  Massachusetts,  01107,  United States
      North Andover,  Massachusetts,  01845,  United States
      North Dartmouth,  Massachusetts,  02747,  United States
Missouri
      St. Louis,  Missouri,  63104,  United States
      St. Louis,  Missouri,  63141,  United States
Nebraska
      Omaha,  Nebraska,  68130,  United States
      Lincoln,  Nebraska,  68505,  United States
New Jersey
      Springfield,  New Jersey,  07081,  United States
      Ocean,  New Jersey,  07712,  United States
New York
      New York,  New York,  10021,  United States
North Carolina
      Raleigh,  North Carolina,  27607,  United States
Ohio
      Canton,  Ohio,  44718,  United States
      Cincinnati,  Ohio,  45231,  United States
Oklahoma
      Oklahoma City,  Oklahoma,  73104,  United States
Oregon
      Lake Oswego,  Oregon,  97035,  United States
      Eugene,  Oregon,  97401,  United States
      Medford,  Oregon,  97504,  United States
Rhode Island
      Providence,  Rhode Island,  02906,  United States
South Carolina
      Orangeburg,  South Carolina,  29118,  United States
Tennessee
      Nashville,  Tennessee,  37203,  United States
Texas
      New Braunfels,  Texas,  78130,  United States
      Austin,  Texas,  78731,  United States
Utah
      Murray,  Utah,  84107,  United States
Vermont
      South Burlington,  Vermont,  05403,  United States
Wisconsin
      West Allis,  Wisconsin,  53227,  United States

Study ID Numbers:  FFR30002
Record last reviewed:  March 2005
Last Updated:  April 1, 2005
Record first received:  February 8, 2005
ClinicalTrials.gov Identifier:  NCT00103454
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08