Recent Updates
Recently added Catalysts

Beclomethasone dipropionate hydrofluoroalkane HFA

Phase 3

Rhinitis, Allergic, Perennial | Small molecule | Respiratory |Teva Pharmaceutical Industries Limited|Last Updated: May 23, 2012

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment474

FDA Designations

No designations recorded

Clinical trial landscape

Beclomethasone dipropionate hydrofluoroalkane HFA · 1 trial · 1 indication

Phase 3 1
NCT01134705Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)Rhinitis, Allergic, Perennial
COMPLETED474 Analytics
PHASE3COMPLETED
Study in Adult and Adolescent Subjects With PAR (Perennial Allergic Rhinitis)
Rhinitis, Allergic, Perennial
NCT01134705474
Unlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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)
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Baseline and Week 6
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BDP HFA 320 µg/dayEXPERIMENTALDuring the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
PlaceboPLACEBO_COMPARATORDuring the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.

Interventions

NameTypeDescription
Beclomethasone dipropionate hydrofluoroalkane HFA Nasal AerosolDRUGBeclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol
Placebo Nasal AerosolDRUGHFA Vehicle Aerosol
Unlock Study Design Details

Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites35

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 po...

Countries:United States
Unlock Eligibility Criteria