| March 28, 2008 |
| November 4, 2008 |
| March 2008 |
| June 2008 (final data collection date for primary outcome measure) |
| change from baseline in 12-hour reflective total nasal symptom score [ Time Frame: 14-days ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00651118 on ClinicalTrials.gov Archive Site |
- Change from baseline in 12 hour instantaneous total nasal symptom score [ Time Frame: 14-days ] [ Designated as safety issue: No ]
- Onset of action assessment [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
- Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Nasal examinations [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
|
| Same as current |
| |
| A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies |
| 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) |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
| Seasonal Allergic Rhinitis |
- Drug: Placebo
- Drug: azelastine hydrochloride
- Drug: azelastine hydrochloride / fluticasone propionate
- Drug: fluticasone propionate
|
- Active Comparator: fluticasone propionate nasal spray
- Experimental: azelastine hydrochloride / fluticasone propionate
- Placebo Comparator: Placebo
- Active Comparator: azelastine hydrochloride
|
| |
| |
| Completed |
| 832 |
| July 2008 |
| June 2008 (final data collection date for primary outcome measure) |
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
|
| Both |
| 12 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00651118 |
| Harry Sacks, MD Vice President, Medical and Scientific Affairs, Meda Pharmaceuticals |
| MP4002 |
| Meda Pharmaceuticals |
|
| Study Director: |
Lewis M. Fredane, MD |
Meda Pharmaceuticals |
|
|
| Meda Pharmaceuticals |
| November 2008 |
