Phase 3
Completed N=340
Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)
Source: ClinicalTrials.gov NCT01024608 ↗Enrolled (actual)
340
Serious AEs
0.3%
Results posted
May 2012
Primary outcomePrimary: Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period — -2.0; -1.0 units on a scale — p=<0.001
Summary
The purpose of the study is to assess the efficacy and safety of an investigational nasal aerosol compared with placebo nasal aerosol in the treatment of seasonal allergic rhinitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period |
-2.0; -1.0 | <0.001 sig |
| SECONDARY Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period |
-1.7; -0.8 | <0.001 sig |
| SECONDARY Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline |
-1.2; -0.8 | 0.005 sig |
| SECONDARY Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period |
-1.3; -0.7 | 0.002 sig |
Eligibility Criteria
Inclusion Criteria
- Informed Consent
- Male or female subjects 12 years of age or older
- Documented history of season allergic rhinitis to mountain cedar pollen
- General good health
- Other criteria apply
Exclusion Criteria
- History of physical findings of nasal pathology (within 60 days prior to screening visit)
- Participation in any investigational drug study 30 days preceding screening visit
- History of respiratory infection/disorder with 14 days preceding screening visit
- Use of any prohibited concomitant medications
- Other criteria apply
Data sourced from ClinicalTrials.gov (NCT01024608). 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.