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Beclomethasone dipropionate HFA

Phase 4

Asthma | Small molecule | Respiratory |Teva Pharmaceutical Industries Limited|Trials Updated: Nov 24, 2015

Beclomethasone dipropionate HFA development status

Highest phase Phase 4 (NCT00071552)
Phase scored for TEVAPhase 2
Registered trials 3 across 2 sponsors since Oct 2003

Beclomethasone dipropionate HFA target and mechanism

ModalitySmall molecule

Also known as Beclomethasone dipropionate HFA Nasal Aerosol, Qvar

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment508

FDA Designations

No designations recorded

Beclomethasone dipropionate HFA clinical trials

Beclomethasone dipropionate HFA · 2 trials · 4 indications

Phase 2 2
NCT01006655The Effect of HFA - Beclomethasone Dipropionate Qvar on Bronchial Hyperreactivity in Preschool ChildrenAsthma
COMPLETED21 Analytics
NCT00854360Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Patients 12 Years and Older With SARSeasonal Allergic Rhinitis
COMPLETED487 Analytics
PHASE2COMPLETED
The Effect of HFA - Beclomethasone Dipropionate Qvar on Bronchial Hyperreactivity in Preschool Children
AsthmaUnlock trial analytics
PHASE2COMPLETED
Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Patients 12 Years and Older With SAR
Seasonal Allergic RhinitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Adenosine Challenge Test
ten weeks

Adenosine challenge test were measured and described as PC 20 - the concentration that corresponded to a FEV1 impairment equal or bigger than 20%. The stage was also recorded

Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period
Baseline (Day -6 to 0) and Days 1-15 (2-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, 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 the 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 Two Week Treatment Period
Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
Change From Baseline in Morning Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period
Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
Baseline and Week 2
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
placebo, adenosine challenge testPLACEBO_COMPARATORControlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceded and succeeded by AMP challenge test,
Qvar, adenosine challenge testACTIVE_COMPARATORPatients will receive 4 weeks of inhale QVAR (HFA beclomethasone) 100µg through a spacer device, twice a day
BDP HFA 80 µg/dayEXPERIMENTALDuring the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 micrograms (µg) BDP HFA and two actuations of placebo HFA once daily.
BDP HFA 160 µg/dayEXPERIMENTALDuring the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
BDP HFA 320 µg/dayEXPERIMENTALDuring the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
PlaceboPLACEBO_COMPARATORDuring the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.

Interventions

NameTypeDescription
Beclomethasone dipropionate HFADRUG100µg twice a day, through inhaler autohaler, using a spacer device, preceded and followed by adenosine challenge test
placeboDRUGinhalation twice a day for one month, preceded and followed by adenosine challenge test
Beclomethasone dipropionate HFA Nasal AerosolDRUGBeclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol
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Eligibility Criteria

Age Range3 Years to 7 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * clinical diagnosis of mild asthma * children aged between 3 - 6 years old * able to perform spirometry and adenosine challenge test * positive challenge test at the time of inclusion * without prophylactic treatment for asthma * signed informed consent to join the research by ...

Countries:IsraelUnited States
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Frequently asked questions about Beclomethasone dipropionate HFA

What is beclomethasone dipropionate HFA?

Beclomethasone dipropionate HFA is an investigational small molecule corticosteroid developed by Teva Pharmaceutical Industries Limited (TEVA). It is being studied in a hydrofluoroalkane propellant formulation for respiratory conditions, specifically asthma and seasonal allergic rhinitis. It is in Phase 2 clinical development.

What is beclomethasone dipropionate HFA used for?

Beclomethasone dipropionate HFA is being studied for asthma and seasonal allergic rhinitis, also known as hayfever. One Phase 2 trial evaluated it in preschool children with asthma and bronchial hyperresponsiveness, and another assessed it in patients 12 years and older with seasonal allergic rhinitis.

Who makes beclomethasone dipropionate HFA?

Beclomethasone dipropionate HFA is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical trials studying this hydrofluoroalkane formulation of beclomethasone dipropionate.

What phase is beclomethasone dipropionate HFA in?

Beclomethasone dipropionate HFA is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. Both of its recorded Phase 2 trials have been completed, and no trials are currently active.

What clinical trials is beclomethasone dipropionate HFA in?

Two completed Phase 2 trials studied beclomethasone dipropionate HFA. NCT01006655 examined the effect of HFA beclomethasone dipropionate Qvar on bronchial hyperreactivity in preschool children with asthma in Israel. NCT00854360 assessed the efficacy and safety of BDP HFA nasal aerosol in patients 12 years and older with seasonal allergic rhinitis in the United States.

Is beclomethasone dipropionate HFA the same as beclomethasone dipropionate HFA Nasal Aerosol?

Yes. Beclomethasone dipropionate HFA is also known as beclomethasone dipropionate HFA Nasal Aerosol. The nasal aerosol name reflects the intranasal formulation studied in seasonal allergic rhinitis, while the same active ingredient was also evaluated as an inhaled formulation in asthma.