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

This study has been completed.
Sponsor:
Information provided by:
Meda Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00720382
First received: July 21, 2008
Last updated: February 19, 2010
Last verified: February 2010
  Purpose

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


Condition Intervention Phase
Perennial Allergic Rhinitis
Drug: 0.15% azelastine hydrochloride
Drug: Mometasone furoate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Active Controlled Trial of the Safety and Tolerability of MP 03-036 (Astepro 0.15%) in Patients With Perennial Allergic Rhinitis

Resource links provided by NLM:


Further study details as provided by Meda Pharmaceuticals:

Primary Outcome Measures:
  • Change From Baseline on Direct Visual Nasal Exams to 12 Months [ Time Frame: Change from baseline to 12 months ] [ Designated as safety issue: Yes ]
    Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation


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
Experimental: 1
0.15% azelastine hydrochloride 1644 mcg
Drug: 0.15% azelastine hydrochloride
1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM
Experimental: 2
Mometasone furoate 200 mcg
Drug: Mometasone furoate
200 mcg (50 mcg/spray) 2 sprays per nostril Once a day (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 days 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: Harry Sacks M.D. Vice President of Medical Affairs, Medical and Scientific Affairs
ClinicalTrials.gov Identifier: NCT00720382     History of Changes
Other Study ID Numbers: MP436
Study First Received: July 21, 2008
Results First Received: November 6, 2009
Last Updated: February 19, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Azelastine
Mometasone furoate
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Lipoxygenase Inhibitors
Enzyme Inhibitors
Anti-Allergic Agents
Therapeutic Uses
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014