Status:
COMPLETED
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
Lead Sponsor:
Meda Pharmaceuticals
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
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 (...
Detailed Description
This will be a Phase III, randomized, double-blind, placebo-controlled, parallel-group study in subjects with moderate-to-severe seasonal allergic rhinitis (SAR). The study will begin with a 7-day, si...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
1791 Patients enrolled
Trial Details
Trial ID
NCT00883168
Start Date
April 1 2009
End Date
July 1 2009
Last Update
June 24 2013
Active Locations (45)
Enter a location and click search to find clinical trials sorted by distance.
1
Allergy, Asthma and Immunology Associates
Scottsdale, Arizona, United States, 85251
2
Clinical Research Center
Encinitas, California, United States, 92024
3
AABI Associates Medical Group
Fountain Valley, California, United States, 92708
4
Allergy & Asthma Care Center of So. Cal
Long Beach, California, United States, 90808