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

Completed · Phase 3 · Has a placebo group

Conditions studied: Seasonal Allergic Rhinitis

In brief

The purpose of this study is to determine if the combination of two allergy medications (formulated azelastine/fluticasone product)is more effective than placebo or either component medication alone (azelastine or fluticasone).

Key facts

Study ID

NCT00883168

Run by

Meda Pharmaceuticals

People needed

1791

Starts

2009-04-01

Expected to finish

2009-07-01

Last updated by the study team

2013-06-24

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male/female subjects 12 years of age and older
• Provide written informed consent/pediatric assent.
• Subjects must have moderate-to-severe rhinitis, with one or more of the following present:
• Sleep disturbance
• Impairment of daily activities, leisure and/or sport
• Impairment of school or work
• Troublesome symptoms
• Screening Visit: Have a 12-hour reflective TNSS of at least 8 out of a possible 12 and a congestion score of 2 or 3 on Visit 1
• Randomization Visit: For the 3 days prior to Randomization and on the morning of Randomization, the sum of the 7 consecutive reflective AM and PM TNSS assessments shall be equal to or greater than 56, with a nasal congestion score equal to or greater than 14
• Randomization Visit: instantaneous TNSS score of at least 8 and a congestion score of at least 2 just prior to beginning the onset of action assessment
• Have taken at least 10 doses of the lead-in medication
• Willing and able to comply with the study requirements
• At least a 2-year history of SAR during the current allergy season
• The presence of IgE-mediated hypersensitivity to a prevailing, individual, seasonal pollen, confirmed by a positive response to skin prick within the last year.
• General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results.
• Subjects receiving immunotherapy injections (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit
• Subjects currently receiving sublingual immunotherapy are excluded. A 6-month washout period is required following the last dose of sublingual immunotherapy.

You may not qualify if…

• On Focused Nasal Examination, the presence of any superficial and moderate nasal mucosal erosion, nasal mucosal ulceration, or nasal septum 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.
• Nasal surgery or sinus surgery within the previous year.
• Chronic sinusitis - more than 3 episodes per year
• Planned travel outside of the pollen area during the study period
• The use of any investigational drug within 30 days prior to Visit 1. 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 Visit 1
• Respiratory Tract Infections requiring antibiotic treatment 14 days prior to Visit 1
• Asthma (with the exception of intermittent asthma).
• 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, 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.
• Patients with a history of glaucoma
• Clinically relevant abnormal physical findings within 1 week of randomization may preclude compliance with the study procedures
• Employees of the research center or private practice and their family members
• no more than 50% of their subjects have participated in protocol MP4001, MP4002 or MP4004

Where it is running

• Allergy, Asthma and Immunology Associates — Scottsdale, Arizona, United States
• Clinical Research Center — Encinitas, California, United States
• AABI Associates Medical Group — Fountain Valley, California, United States
• Allergy & Asthma Care Center of So. Cal — Long Beach, California, United States
• Allergy Research Foundation — Los Angeles, California, United States
• Southern California Research — Mission Viejo, California, United States
• Allergy Associates Medical Group Inc — San Diego, California, United States
• Allergy and Asthma Medical Group and Research Center — San Diego, California, United States
• Bensch Research Associates — Stockton, California, United States
• Allergy and Asthma Clinical Research, Inc. — Walnut Creek, California, United States
• Asthma and Allergy Associates — Colorado Springs, Colorado, United States
• Storms Clinical Research Institute — Colorado Springs, Colorado, United States
• Colorado Allergy and Asthma Centers — Denver, Colorado, United States
• Clinical Research Atlanta — Atlanta, Georgia, United States
• Sneeze, Wheeze and Itch Associates — Normal, Illinois, United States
• Kansas City Allergy and Asthma — Overland Park, Kansas, United States
• Family Allergy and Asthma Reserach — Louisville, Kentucky, United States
• Northeast Medical Research Associates — North Dartmouth, Massachusetts, United States
• Clinical Reseacrh Institute — Minneapolis, Minnesota, United States
• The Clinical Research Center — St Louis, Missouri, United States
• The Asthma and Allergy Center — Papillion, Nebraska, United States
• Atlantic Research Center — Ocean City, New Jersey, United States
• Princeton Center for Clinical Research — Skillman, New Jersey, United States
• Research Asthma, Sinus and Allergy Centers — Warren Township, New Jersey, United States
• North Carolina Clinical Research — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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