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Albuterol HFA-BOI

Phase 2

Asthma | Small molecule | Respiratory |Teva Pharmaceutical Industries Limited|Trials Updated: Nov 30, 2021

Albuterol HFA-BOI development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Feb 2003

Albuterol HFA-BOI target and mechanism

Molecular targetADRB2
Target classAgonist
ModalitySmall molecule
ChEMBLCHEMBL714

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Albuterol HFA-BOI clinical trials

Albuterol HFA-BOI · 1 trial · 1 indication

Phase 2 1
NCT00054964Comparative Effectiveness of a Breath-operated Albuterol Inhaler in Asthma Patients With Poor Inhaler TechniqueAsthma
COMPLETED14 Analytics
PHASE2COMPLETED
Comparative Effectiveness of a Breath-operated Albuterol Inhaler in Asthma Patients With Poor Inhaler Technique
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent change in SGaw (A measure of the change in specific airway conductance - how hard it is to get air into the lungs)
Pre-dose and +120 minutes

Secondary Endpoints

The area-under-the-effect curve of change in SGaw from basline over time
Pre-dose and +120 minutes
The maximum increase in SGaw from baseline over two hours
Baseline through +120 minutes
Time in hours to the maximum increase in SGaw from baseline
Baseline through +120 minutes post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Albuterol HFA-BOIEXPERIMENTAL -
Albuterol HFA-MDIACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Albuterol HFA-BOIDRUGAlbuterol HFA breath operated inhaler, 90 mcg/sprau
Albuterol HFA-MDIDRUGAlbuterol HFA multi-dose inhaler
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Asthma diagnosed ≥6 months prior and stable for 4 weeks prior to screening * Poor inhaler coordination as assessed at screening * Reversible bronchoconstriction (≥ 12% increase in FEV1) Exclusion Criteria: * Albuterol allergy * Investigational drug within 30 days * Injected ...

Countries:United States
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Frequently asked questions about Albuterol HFA-BOI

What is Albuterol HFA-BOI?

Albuterol HFA-BOI is an investigational breath-operated albuterol inhaler being developed by Teva Pharmaceutical Industries Limited for asthma. It is a small molecule formulation designed to deliver albuterol, a short-acting beta-agonist, through a breath-actuated device. It is in Phase 2 clinical development and has not been approved by the FDA.

What is Albuterol HFA-BOI used for in asthma?

Albuterol HFA-BOI is being studied for use in asthma patients, specifically those with poor inhaler technique. The breath-operated design aims to deliver albuterol reliably when the patient inhales. It is an investigational product and is not yet approved for any indication.

What does Albuterol HFA-BOI target?

Albuterol HFA-BOI targets the beta-2 adrenergic receptor, also known as ADRB2. It acts as an agonist at this receptor, which is the same mechanism as standard albuterol. This receptor activation leads to bronchodilation in the airways.

Who is developing Albuterol HFA-BOI?

Albuterol HFA-BOI is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor of the clinical program for this breath-operated albuterol inhaler.

What phase is Albuterol HFA-BOI in?

Albuterol HFA-BOI is in Phase 2 clinical development. It is an investigational product and has not been approved by the FDA. The Phase 2 trial has been completed, and no active trials are currently listed.

What clinical trials is Albuterol HFA-BOI in?

Albuterol HFA-BOI has been studied in one completed Phase 2 trial, NCT00054964, titled Comparative Effectiveness of a Breath-operated Albuterol Inhaler in Asthma Patients With Poor Inhaler Technique. The trial enrolled 14 adults in the United States and used an active-controlled, randomized design.