Phase 3 N=340 Randomized Double-blind Treatment

Study in Adult and Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)

Seasonal Allergic Rhinitis · Hay Fever

Bottom Line

View on ClinicalTrials.gov: NCT01024608 ↗

Enrolled (actual)

340

Serious AEs

0.3%

Results posted

May 2012

Primary outcome: 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 units on a scale — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Beclomethasone dipropionate (Drug); Placebo Nasal Aerosol (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Primary completion: Feb 2010

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

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.

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

View full record on ClinicalTrials.gov →

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.