Study in Adult and Adolescent Subjects… | Clinical Trial

Key information

Conditions

Rhinitis, Allergic, Perennial Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Teva Clinical Study Site, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol

Drug

Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol

Other names: QNASL(TM)

Placebo Nasal Aerosol

Drug

HFA Vehicle Aerosol

Primary outcomes

Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period

Time frame: 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 outcomes

Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period

Time frame: 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)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study title

Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol (320 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Adult and Adolescent Subjects (12 Years of Age and Older)

Important dates

Study start: 2010
Primary completion: 2010
Study completion: 2010
First posted: Jun 2, 2010
Registry last updated: May 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed