Phase 3
Completed N=703
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
| Outcome | Result | p-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
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.