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A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
This study has been completed.
First Received: April 14, 2008   Last Updated: April 16, 2008   History of Changes
Sponsored by: Meda Pharmaceuticals
Information provided by: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00660829
  Purpose

The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone.


Condition Intervention Phase
Seasonal Allergic Rhinitis
Drug: Placebo
Drug: 0.15% Azelastine Hydrochloride
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title: Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 in Subjects With Seasonal Allergic Rhinitis

Resource links provided by NLM:


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-day ] [ 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: 536
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
Placebo
2: Active Comparator
0.15% Azelastine Hydrochloride
Drug: 0.15% Azelastine Hydrochloride
0.15% Azelastine Hydrochloride 822 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 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 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 Screening. No investigational products are permitted for use during the conduct of this study
  • Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
  • Women who are pregnant or nursing
  • Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception
  • Respiratory Tract Infections within 14 days prior to 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 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: NCT00660829

Locations
United States, Texas
Allergy and Asthma Center
Waco, Texas, United States, 76712
Central Texas Research
New Braunfels, Texas, United States, 78130
Sylvana Research Associates
San Antonio, Texas, United States, 78229
Biogenics Research Institute
San Antonio, Texas, United States, 78229
Allergy and Asthma Center of Austin
Austin, Texas, United States, 78759
Allergy and Asthma Associates
Austin, Texas, United States, 78731
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: MP440
Study First Received: April 14, 2008
Last Updated: April 16, 2008
ClinicalTrials.gov Identifier: NCT00660829     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Neurotransmitter Agents
Otorhinolaryngologic Diseases
Anti-Asthmatic Agents
Rhinitis
Anti-Allergic Agents
Azelastine
Lipoxygenase Inhibitors
Histamine
Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Histamine Antagonists
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Histamine H1 Antagonists
Histamine phosphate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:
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
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
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 11, 2009