A Study to Evaluate the Safety and Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis - Full Text View

Sponsored by:	Meda Pharmaceuticals
Information provided by:	Meda Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00720382

Purpose

The purpose of this study is to determine if one allergy (0.15% azelastine hydrochloride)is as safe as mometasone furoate alone.

Condition	Intervention	Phase
Perennial Allergic Rhinitis	Drug: 0.15% azelastine hydrochloride Drug: Mometasone furoate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	Active Controlled Trial of the Safety and Tolerability of MP 03-036 in Patients With Perennial Allergic Rhinitis

Resource links provided by NLM:

MedlinePlus related topics: Allergy

Drug Information available for: Azelastine Azelastine hydrochloride Mometasone furoate

U.S. FDA Resources

Further study details as provided by Meda Pharmaceuticals:

Primary Outcome Measures:

Frequency of patient-reported adverse events. Nasal symptoms that have been reported with nasal medications. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Frequency of patient-reported non-nasal adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Change from baseline on direct visual nasal exams [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change from baseline on RQLQ [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	703
Study Start Date:	March 2007
Study Completion Date:	July 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 0.15% azelastine hydrochloride 1644 mcg	Drug: 0.15% azelastine hydrochloride 1644 mcg (205.5 mcg/spray) 2 sprays per nostril bid
2: Experimental Mometasone furoate 200 mcg	Drug: Mometasone furoate 200mcg (50 mcg/spray) 2 sprays per nostril qd AM

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 and older with a compatible history greater than or equal to 1 year of rhinitis due to perennial allergies.
Must be willing and able to provide informed consent and to participate in all study procedures
Must be in generally good health
Positive skin test to a prevalent perennial allergen

Exclusion Criteria:

On nasal examination, the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
Use of any investigational drug within 30 dyas of the first visit
Any nasal surgery or sinus surgery within the previous year
Presence of any hypersensitivity to drugs similar to azelastine or mometasone furoate and to either sorbital or sucralose
Women who are pregnant or nursing
Women who are not using an acceptable method of birth control
Nasal Diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities.
Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with investigator.
Patients with Arrythmia
Patients with know history of alcohol and drug abuse
Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of the study.
Use of medications that could affect the study results

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720382

Show 59 Study Locations

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 M.D. Vice President of Medical Affairs )
Study ID Numbers:	MP436
Study First Received:	July 21, 2008
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00720382 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anti-Inflammatory Agents
Neurotransmitter Agents
Otorhinolaryngologic Diseases
Mometasone furoate
Anti-Asthmatic Agents
Rhinitis
Anti-Allergic Agents
Azelastine
Lipoxygenase Inhibitors
Histamine
Hypersensitivity

Histamine Antagonists
Rhinitis, Allergic, Perennial
Respiratory Tract Diseases
Respiratory Tract Infections
Hypersensitivity, Immediate
Histamine H1 Antagonists
Histamine phosphate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

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
Rhinitis, Allergic, Perennial
Therapeutic Uses
Otorhinolaryngologic Diseases
Immune System Diseases
Mometasone furoate

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

ClinicalTrials.gov processed this record on September 09, 2009