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Phase 3 Completed N=703 Randomized Treatment

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

Perennial Allergic Rhinitis
Source: ClinicalTrials.gov NCT00720382 ↗
Enrolled (actual)
703
Serious AEs
1.1%
Results posted
Jan 2010
Primary outcomePrimary: Change From Baseline on Direct Visual Nasal Exams to 12 Months — 466; 237; 456; 229 Participants

Summary

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

Outcome Measures

OutcomeResultp-value
PRIMARY
Change From Baseline on Direct Visual Nasal Exams to 12 Months
466; 237; 456; 229; 10; 8

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00720382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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