A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
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
Randomised, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis
Conditions
- Seasonal Allergic Rhinitis
Study Type
Interventional
Study Design
Treatment, Randomised, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Further Details
Primary Outcome Measures:
- change from baseline in 12-hour reflective total nasal symptom score
Secondary Outcome Measures:
- Change from baseline in 12 hour instantaneous total nasal symptom score
- Onset of action assessment
- Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
- Nasal examinations
Study Start
March, 2008
Eligibility & Criteria
Official Title
Randomised, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis
Conditions
- Seasonal Allergic Rhinitis
Study Type
Interventional
Study Design
Treatment, Randomised, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Further Details
Primary Outcome Measures:
- change from baseline in 12-hour reflective total nasal symptom score
Secondary Outcome Measures:
- Change from baseline in 12 hour instantaneous total nasal symptom score
- Onset of action assessment
- Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
- Nasal examinations
Study Start
March, 2008
Eligibility & Criteria
Eligibility
- Ages Eligible for Study: 12 Years and older
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers: No
Criteria
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 all study procedures
- Positive skin test to a prevalent spring allergen
Exclusion criteria
- On nasal examination, the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
- Nasal disease likely to affect the deposition of the medication or evaluation, such as sinus infection, nasal polyps or severe deviated septum
- Nasal or sinus surgery within the previous 6 months
- Chronic sinus infection (more than 3 per year)
- Planned travel outside the study area during the study period
- Use of any investigational drug within 30 days of the first visit
- Hypersensitivity (bad reaction) to azelastine hydrchloride nasal spray (Astelin), or fluticasone propionate nasal spray (Flonase)
- Women who are not using an acceptable method of birth control
- Women who are pregnant or nursing
- Upper respiratory tract infection such as common cold, flu, sinus infection within 2 weeks of first study visit
- Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with the investigator
- Irregular heartbeat or other symptomatic heart conditions
- History of alcohol or drug abuse
- History of glaucoma
- Use of medications that could affect the study results
Total Enrolment
780
Contact Details
Location Details
Location: Allergy, Asthma and Immunology Associates
7514 East Monterey Way, Suite #1
Scottsdale, Arizona 85251
Contact Details
POC: Lewis M. Fredane, MD
Phone No.: +1 (480) 949-7377
Fax No.: +1 (480) 949-8339
Email: contact@allergyasthmaaz.com
Website: www.allergyasthmaaz.com
Total Enrolment
780
Contact Details
Location Details
Location: Allergy, Asthma and Immunology Associates
7514 East Monterey Way, Suite #1
Scottsdale, Arizona 85251
Contact Details
POC: Lewis M. Fredane, MD
Phone No.: +1 (480) 949-7377
Fax No.: +1 (480) 949-8339
Email: contact@allergyasthmaaz.com
Website: www.allergyasthmaaz.com
Dates
Tags
Created by: