Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)

Phase 3

Completed

• Conditions: Rhinitis, Allergic, Perennial
• Interventions: Drug: Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol; Drug: Placebo Nasal Aerosol

• Registration Number: NCT01134705
• 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 perennial allergic rhinitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-27
• Study First Submitted QC: 2010-06-01
• Study First Posted: 2010-06-02
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Disposition First Submitted: 2011-08-25
• Disposition First Submitted QC: 2011-08-25
• Disposition First Posted: 2011-08-29
• Status Verified: 2012-04
• Results First Submitted: 2012-04-23
• Results First Submitted QC: 2012-04-23
• Last Update Submitted: 2012-04-23
• Results First Posted: 2012-05-23
• Last Update Posted: 2012-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 474

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BDP HFA 320 µg/day	Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol	During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
Placebo	Placebo Nasal Aerosol	During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period	Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)	Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM \& PM) using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping).; The total nasal symptom score (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 AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period	Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)	Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the 10 minutes prior to assessment twice daily (AM \& PM) using the following scale: 0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of symptoms, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities and/or sleeping).; The total nasal symptom score (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 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)	Baseline and Week 6	The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. A negative change from Baseline score indicates improvement.

Trial Locations

Locations (1)

Teva Clinical Study Site; 🇺🇸 Bellevue, Washington, United States