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

Phase 3

Completed

• Conditions: Seasonal Allergic Rhinitis; Hay Fever
• Interventions: Drug: Placebo Nasal Aerosol; Drug: Beclomethasone dipropionate

• Registration Number: NCT01024608
• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-03
• Study Start: 2009-12-31
• Primary Completion: 2010-02-28
• Study Completion: 2010-02-28
• Disposition First Submitted: 2011-08-25
• Disposition First Submitted QC: 2011-08-25
• Disposition First Posted: 2011-08-29
• Results First Submitted: 2012-04-23
• Results First Submitted QC: 2012-04-23
• Results First Posted: 2012-05-23
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 340

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Nasal Aerosol	During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
BDP HFA 320 µg/day	Beclomethasone dipropionate	During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily each morning.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period	Baseline (Days -3 to 0), and Days 1-15	Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale: 0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities and/or sleeping).; The rTNSS (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates symptom improvement.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period	Baseline (Days -3 to 0), and Days 1-15	Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 10 minutes (prior to the assessment) twice daily (AM and PM) using the following scale: 0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).; The iTNSS (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates symptom improvement.
Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline	Day 0 (Baseline), Day 15	The adult RQLQ has 28 questions in 7 domains. Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Not Troubled to 6 = Extremely Troubled) for the domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, and eye symptoms. The domain of 'emotional' utilized a separate scale (0 = None of the time to 6 = All of the time). The overall RQLQ score is the mean of all 28 responses. Week 2 scores were compared to baseline scores. A negative change from baseline score indicates improvement.
Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period	Baseline (Days -3 to 0), and Days 1-15	Participants recorded the severity of their ocular symptoms (Itching/burning eyes, tearing/watering eyes, and redness of eyes) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale: 0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities).; The total ocular symptom score ranges from 0 to 9 (worst symptoms). A negative change from baseline score indicates improvement.

Trial Locations

Locations (1)

Teva Clinical Trial Site; 🇺🇸 Waco, Texas, United States