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

Sponsor:	Meda Pharmaceuticals
Information provided by:	Meda Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00660517

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: fluticasone propionate Drug: azelastine hydrochloride/fluticasone propionate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Astelin Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis

Resource links provided by NLM:

MedlinePlus related topics: Allergy Hay Fever

Drug Information available for: Azelastine Azelastine hydrochloride Fluticasone propionate Fluticasone

U.S. FDA Resources

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 ]
Change from Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) [ Time Frame: 14 Days ] [ Designated as safety issue: No ]

Enrollment:	610
Study Start Date:	December 2007
Study Completion Date:	April 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo	Drug: Placebo
2: Active Comparator Active Comparator	Drug: azelastine hydrochloride azelastine hydrochloride 548 mcg
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

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female subjects 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 in all study procedures
Positive skin test to a prevalent Texas Mountain Cedar allergen

Exclusion Criteria:

On Focused Nasal Examination, the presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation (Grade 1b - 4) at either the screening visit or randomization visit will disqualify the subject from the study.
Other nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.
Nasal surgery or sinus surgery within the previous year.
Chronic sinusitis - more than 3 episodes per year
Planned travel outside of the study area during the study period
The use of any investigational drug within 30 days prior to Day screening. No investigational products are permitted for use during the conduct of this study
Presence of any hypersensitivity to drugs similar to azelastine hydrochloride or fluticasone propionate
Women who are pregnant or nursing
Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception* see section 6.1.1
Respiratory Tract Infections within 14 days prior to Day screening
Respiratory Tract Infections requiring antibiotic treatment 14 days prior to screening
Asthma (with the exception of mild, intermittent asthma). Subjects with mild, intermittent asthma who only require short-acting inhaled bronchodilators (not more often than twice per week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment
Significant pulmonary disease including COPD
Clinically significant arrhythmia or symptomatic cardiac conditions
A known history of alcohol or drug abuse within the last 2 years
Existence of any surgical or medical condition or physical or laboratory findings, which in the opinion of the investigator or sponsor's medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug; that might significantly affect the subject's ability to complete this trial; or their safety in this trial.
Clinically relevant abnormal physical findings within 1 week of randomization which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660517

Locations

United States, Texas
Allergy and Asthma Associates
Austin, Texas, United States, 78731
Allergy and Asthma Center
Waco, Texas, United States, 76712
Central Texas Research
New Braunfels, Texas, United States, 78130
Allergy, Asthma Research Center
San Antonio, Texas, United States, 78258
Allergy and Asthma Care
Waco, Texas, United States, 76708
Southwest Allergy and Asthma Center, P.A.
San Antonio, Texas, United States, 78229
Sylvana Research Associates
San Antonio, Texas, United States, 78229

Sponsors and Collaborators

Meda Pharmaceuticals

Investigators

Study Director:

Lewis M Fredane, MD

Meda Pharmaceuticals

More Information

No publications provided

Responsible Party:	Medical and Scientific Affairs ( Harry Sacks, MD Vice President )
Study ID Numbers:	MP4001
Study First Received:	April 14, 2008
Last Updated:	April 16, 2008
ClinicalTrials.gov Identifier:	NCT00660517 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Rhinitis
Azelastine
Hypersensitivity
Respiratory Tract Infections
Respiratory Tract Diseases
Therapeutic Uses
Fluticasone
Dermatologic Agents
Otorhinolaryngologic Diseases
Immune System Diseases

Anti-Asthmatic Agents
Histamine Agents
Enzyme Inhibitors
Anti-Allergic Agents
Nose Diseases
Pharmacologic Actions
Lipoxygenase Inhibitors
Histamine Antagonists
Autonomic Agents
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Histamine H1 Antagonists
Peripheral Nervous System Agents
Histamine H1 Antagonists, Non-Sedating
Bronchodilator Agents

ClinicalTrials.gov processed this record on November 27, 2009