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albuterol by HFA MDI

Phase 3

Exercise-induced Bronchospasm | Small molecule | Respiratory |Teva Pharmaceutical Industries Limited|Trials Updated: Nov 24, 2021

albuterol by HFA MDI target and mechanism

Molecular targetADRB2
Target classAgonist
ModalitySmall molecule
ChEMBLCHEMBL714

Also known as albuterol aerosol by HFA MDI

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

albuterol by HFA MDI clinical trials

albuterol by HFA MDI · 1 trial · 1 indication

Phase 3 1
NCT00085774Comparison of Two Bronchodilator Inhalers in Adolescents and Adults With Exercise-Induced AsthmaExercise-induced Bronchospasm
COMPLETED24 Analytics
PHASE3COMPLETED
Comparison of Two Bronchodilator Inhalers in Adolescents and Adults With Exercise-Induced Asthma
Exercise-induced BronchospasmUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary endpoint was mean maximum % change in the baseline absolute forced expiratory volume in 1 second (FEV1) value observed up to 1 hour post-challenge.
Three doses 2-7 days apart

Secondary Endpoints

Mean maximum percent change in the baseline percent predicted FEV1 value observed up to one hour post-challenge
exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Mean maximum absolute change in the baseline absolute FEV1 value observed up to one hour post-challenge
exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
Mean percent change in the baseline absolute FEV1 value at each post-challenge time point
exercise challenge 30 minutes after dosing and assessments over 60 +/- 10 minutes
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Albuterol HFA BOIEXPERIMENTAL -
Albuterol HFA MDIEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
albuterol aerosol by HFA MDIDRUGalbuterol HFA MDI 160 mcg
albuterol aerosol by HFA BOIDRUGalbuterol HFA BOI 160 mcg
placebo aerosol by HFADRUGplacebo HFA
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Eligibility Criteria

Age Range12 Years to 40 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Provide written informed consent * Male or non-pregnant, non-nursing females aged 12 40 years, inclusive, at the first screening visit * Have exercise-induced bronchospasm (EIB), with or without asthma, as demonstrated by a ≥15% decrease in pre-challenge absolute FEV1 observed...

Countries:United States
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Frequently asked questions about albuterol by HFA MDI

What is albuterol by HFA MDI used for?

Albuterol by HFA MDI is an inhaled bronchodilator studied for exercise-induced bronchospasm, a narrowing of the airways triggered by physical activity. It is delivered as an aerosol through a hydrofluoroalkane metered-dose inhaler and is being developed for the respiratory therapeutic area.

How does albuterol by HFA MDI work?

Albuterol by HFA MDI works as an agonist at ADRB2, the beta-2 adrenergic receptor. Binding to this receptor relaxes the smooth muscle surrounding the airways, which helps open them and relieve the bronchoconstriction that occurs during exercise-induced bronchospasm.

Who makes albuterol by HFA MDI?

Albuterol by HFA MDI is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor behind the clinical program for this inhaled bronchodilator in exercise-induced bronchospasm.

What phase is albuterol by HFA MDI in?

Albuterol by HFA MDI is in Phase 3 development. It is an investigational small molecule and has not been established as approved for marketing. The Phase 3 trial in its program has been completed.

What clinical trials is albuterol by HFA MDI in?

Albuterol by HFA MDI has been studied in one completed Phase 3 trial, NCT00085774, titled Comparison of Two Bronchodilator Inhalers in Adolescents and Adults With Exercise-Induced Asthma. That randomized, double-blind, placebo-controlled trial enrolled 24 participants in the United States, ages 12 and older.

Is albuterol by HFA MDI the same as albuterol aerosol by HFA MDI?

Yes. Albuterol by HFA MDI is also known as albuterol aerosol by HFA MDI. Both names refer to the same hydrofluoroalkane metered-dose inhaler formulation of albuterol developed by Teva Pharmaceutical Industries Limited for exercise-induced bronchospasm.