A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies - Full Text View

Sponsored by:	Meda Pharmaceuticals
Information provided by:	Meda Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00651118

Purpose

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)

Condition	Intervention	Phase
Seasonal Allergic Rhinitis	Drug: Placebo Drug: azelastine hydrochloride Drug: azelastine hydrochloride / fluticasone propionate Drug: fluticasone propionate	Phase III

MedlinePlus related topics: Allergy Hay Fever

Drug Information available for: Fluticasone Fluticasone propionate Azelastine Azelastine hydrochloride

U.S. FDA Resources

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

Further study details as provided by Meda Pharmaceuticals:

Primary Outcome Measures:

change from baseline in 12-hour reflective total nasal symptom score [ Time Frame: 14-days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	832
Study Start Date:	March 2008
Study Completion Date:	July 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
3: Active Comparator fluticasone propionate nasal spray	Drug: fluticasone propionate fluticasone propionate 200 mcg
4: Experimental azelastine hydrochloride / fluticasone propionate	Drug: azelastine hydrochloride / fluticasone propionate azelastine hydrochloride 548 mcg / fluticasone propionate 200 mcg
1: Placebo Comparator Placebo	Drug: Placebo Placebo
2: Active Comparator azelastine hydrochloride	Drug: azelastine hydrochloride azelastine hydrochloride 548 mcg

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651118

Show 43 Study Locations

Sponsors and Collaborators

Meda Pharmaceuticals

Investigators

Study Director:

Lewis M. Fredane, MD

Meda Pharmaceuticals

More Information

Responsible Party:	Meda Pharmaceuticals ( Harry Sacks, MD Vice President, Medical and Scientific Affairs )
Study ID Numbers:	MP4002
Study First Received:	March 28, 2008
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00651118
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate

Histamine phosphate
Fluticasone
Rhinitis
Azelastine
Histamine
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Histamine Agents
Enzyme Inhibitors
Anti-Allergic Agents
Nose Diseases

Pharmacologic Actions
Lipoxygenase Inhibitors
Histamine Antagonists
Autonomic Agents
Therapeutic Uses
Histamine H1 Antagonists
Peripheral Nervous System Agents
Histamine H1 Antagonists, Non-Sedating
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009