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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00720382
First Posted: July 22, 2008
Last Update Posted: May 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Meda Pharmaceuticals
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 irritation 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


Other Outcome Measures:
  • Change From Baseline to 12 Months in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older [ Time Frame: change from baseline to 12 months ]

    A 28-item RQLQ was completed on Day 1, Month 1, Month 3, Month 6, month 9 and month 12 or Early termination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time.

    Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.



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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720382


  Show 59 Study Locations
Sponsors and Collaborators
Meda Pharmaceuticals
Investigators
Study Director: Lewis M. Fredane, MD Meda Pharmaceuticals
  More Information

Responsible Party: Meda Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00720382     History of Changes
Other Study ID Numbers: MP436
First Submitted: July 21, 2008
First Posted: July 22, 2008
Results First Submitted: November 6, 2009
Results First Posted: January 15, 2010
Last Update Posted: May 21, 2015
Last Verified: May 2015

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