Phase 3
N=474
Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)
Rhinitis, Allergic, Perennial
Bottom Line
View on ClinicalTrials.gov: NCT01134705 ↗Enrolled (actual)
474
Serious AEs
0.2%
Results posted
May 2012
Primary outcome: Primary: Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period — -2.5; -1.6 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol (Drug); Placebo Nasal Aerosol (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period |
-2.5; -1.6 | <0.001 sig |
| SECONDARY Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period |
-2.1; -1.4 | <0.001 sig |
| SECONDARY Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) |
-1.5; -0.9 | 0.001 sig |
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 perennial allergic rhinitis.
Eligibility Criteria
Inclusion Criteria
- Informed Consent
- Documented history of perennial allergic rhinitis
- A demonstrated sensitivity to at least one allergen known to induce PAR through a standard skin prick test.
- Minimum subject-reported reflective total nasal symptom score (rTNSS) of at least 6 (out of a possible 12)
- 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 or during the run-in period
- Use of any prohibited concomitant medications
Data sourced from ClinicalTrials.gov (NCT01134705). 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.