Phase 3
N=832
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
Seasonal Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT00651118 ↗Enrolled (actual)
832
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcome: Primary: Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (rTNSS) — -5.6; -4.7; -4.2; -2.9 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); azelastine Hcl (Drug); azelastineHcl / fluticasone propionate (Drug); fluticasone propionate (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Meda Pharmaceuticals
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (rTNSS) |
-5.6; -4.7; -4.2; -2.9 | — |
| SECONDARY Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS) |
-5.2; -4.5; -4.0; -2.6 | — |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days |
-1.6; -1.6; -1.4; -0.9 | — |
Summary
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)
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00651118). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.