Phase 3
Completed N=581
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergies
Perennial Allergic Rhinitis
Source: ClinicalTrials.gov NCT00712920 ↗
Enrolled (actual)
581
Serious AEs
0.0%
Results posted
Jan 2010
Primary outcomePrimary: Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days. — 14.7; 15.5; 15.8; -3.1 Scores on a Scale — p=0.03
Summary
The purpose of this study is to determine if two allergy medications are more effective than placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days. |
14.7; 15.5; 15.8; -3.1; -3.8; -4.0 | 0.03 sig |
| SECONDARY Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days |
13.28; 13.91; 14.30; -2.72; -3.36; -3.51 | 0.102 |
| SECONDARY Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days |
11.20; 11.77; 12.39; -1.79; -2.23; -2.92 | 0.226 |
| SECONDARY Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days |
2.98; 3.18; 3.29; -0.81; -1.05; -0.94 | 0.292 |
| SECONDARY Change From Baseline on Direct Visual Nasal Exams and 28 Days |
189; 194; 185; 3; 3; 7 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients 12 years of age and older
- Must be in generally good health
- Must meet minimum symptom requirements, as specified in protocol
- Must be willing and able to provide informed consent and participate in all study procedures
- 2-year history of PAR
- Positive skin test to cockroach, dust mite, mold or cat/dog dander
Exclusion Criteria
- On nasal examination, presence of any nasal mucosal erosion, nasal ulceration or nasal septal perforation at the screening or randomization visit
- Nasal diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, significant polyposis or nasal structural abnormalities
- Nasal surgery or sinus surgery within the previous year
- The use of any investigational drug within 30 days
- Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose
- Women who are pregnant or nursing
- Women of child-bearing potential who are not abstinent and not practicing a medically acceptable method of contraception
- Respiratory tract infection within 2 weeks of screening
- Respiratory tract infections requiring oral antibiotic treatment within 2 weeks of screening
- Patients with asthma with the exception of mild, intermittent
- Significant pulmonary disease including COPD
- Patients with arrhythmia
- Patients with a known history of alcohol or drug abuse
- Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor may significantly alter the absorption, distribution, metabolism or excretion of study drug.
- Clinically relevant abnormal physical findings within one week of randomization
- Overnight abscences from home for more than 3 nights
- Employees of the research center or private practice and family members are excluded
- Patients who received prohibited medications within specified timepoints in protocol.
Data sourced from ClinicalTrials.gov (NCT00712920). 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.