Official Title: “Randomized, 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”

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)

Study Type: Interventional

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

Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

• Drug: Placebo
  • Placebo
• Drug: azelastine hydrochloride
  • azelastine hydrochloride 548 mcg
• Drug: azelastine hydrochloride / fluticasone propionate
  • azelastine hydrochloride 548 mcg / fluticasone propionate 200 mcg
• Drug: fluticasone propionate
  • fluticasone propionate 200 mcg

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 3
  • fluticasone propionate nasal spray
• Experimental: 4
  • azelastine hydrochloride / fluticasone propionate
• Placebo Comparator: 1
  • Placebo
• Active Comparator: 2
  • azelastine hydrochloride

Primary Measures

• change from baseline in 12-hour reflective total nasal symptom score
  • Time Frame: 14-days
    Safety Issue?: No

Secondary Measures

• Change from baseline in 12 hour instantaneous total nasal symptom score
  • Time Frame: 14-days
    Safety Issue?: No
• Onset of action assessment
  • Time Frame: 4 hours
    Safety Issue?: No
• Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
  • Time Frame: 14 days
    Safety Issue?: No
• Nasal examinations
  • Time Frame: 14 days
    Safety Issue?: Yes

Inclusion Criteria:

• Male and female patients 12 years of age and older with a 2 year history of moderate to severe sasonal allergic rhinitis
• Must be in generally good health
• Must meet minimum symptom requirements, as specified in the protocol
• Must be wiling 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 or 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Meda Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Lewis M. Fredane, MD Study Director Meda Pharmaceuticals  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00651118

Study ID Number: MP4002

ClinicalTrials.gov Identifier: NCT00651118

Health Authority: United States: Food and Drug Administration