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

Sponsored by:	Meda Pharmaceuticals
Information provided by:	Meda Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00712920

Purpose

The purpose of this study is to determine if two allergy medications are more effective than placebo.

Condition	Intervention	Phase
Perennial Allergic Rhinitis	Drug: 0.15% azelastine hydrochloride Drug: 0.1% azelastine hydrochloride Drug: Placebo	Phase III

MedlinePlus related topics: Allergy

Drug Information available for: Azelastine Azelastine hydrochloride

U.S. FDA Resources

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, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 and MP03-33 in Patients With Perennial 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: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in instantaneous TNSS compared to placebo [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Change from baseline in 12-hour reflective individual symptom scores compared to placebo [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Daily change from baseline in 12-hour reflective and instantaneous TNSS compared to placebo [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Change from baseline in 12-hour reflective SSCS compared to placebo [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Change from baseline in 12-hour reflective SSCS individual symptom scores [ Time Frame: 28 days ] [ Designated as safety issue: No ]
Change from baseline in RQLQ [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
Change from baseline o n direct visual nasal exams [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Study Start Date:

January 2007

Arms	Assigned Interventions
1: Placebo Comparator Placebo	Drug: Placebo Placebo
2: Experimental 0.15% azelastine hydrochloride 1644 mcg	Drug: 0.15% azelastine hydrochloride 0.15% azelastine hydrochloride 1644 mcg
3: Experimental 0.1% azelastine hydrochlorid	Drug: 0.1% azelastine hydrochloride 0.1% azelastine hydrochloride 1096 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
Must be in generally good health
Must meet minimum symptom requirements, as specified in protocol
Must be willing and able to provide informed consent and participate in all study procedures
2-year history of PAR
Positive skin test to cockroach, dust mite, mold or cat/dog dander

Exclusion Criteria:

On nasal examination, presence of any nasal mucosal erosion, nasal ulceration or nasal septal perforation at the screening or randomization visit
Nasal diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, significant polyposis or nasal structural abnormalities
Nasal surgery or sinus surgery within the previous year
The use of any investigational drug within 30 days
Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose
Women who are pregnant or nursing
Women of child-bearing potential who are not abstinent and not practicing a medically acceptable method of contraception
Respiratory tract infection within 2 weeks of screening
Respiratory tract infections requiring oral antibiotic treatment within 2 weeks of screening
Patients with asthma with the exception of mild, intermittent
Significant pulmonary disease including COPD
Patients with arrhythmia
Patients with a known history of alcohol or drug abuse
Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor may significantly alter the absorption, distribution, metabolism or excretion of study drug.
Clinically relevant abnormal physical findings within one week of randomization
Overnight abscences from home for more than 3 nights
Employees of the research center or private practice and family members are excluded
Patients who received prohibited medications within specified timepoints in protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00712920

Show 43 Study Locations

Sponsors and Collaborators

Meda Pharmaceuticals

More Information

Responsible Party:	Meda Pharmaceuticals ( Harry Sacks, MD Vice President, Medical and Scientific Affairs )
Study ID Numbers:	MP434
Study First Received:	July 8, 2008
Last Updated:	July 21, 2008
ClinicalTrials.gov Identifier:	NCT00712920
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, Perennial
Hypersensitivity, Immediate

Histamine phosphate
Rhinitis
Azelastine
Histamine
Respiratory Hypersensitivity

Additional relevant MeSH terms:

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
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 14, 2009