Recent Updates
Recently added Catalysts

albuterol by HFA MDI

Phase 3

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

Target and mechanism

ModalitySmall molecule

Also known as albuterol aerosol by HFA MDI

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

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 Bronchospasm
NCT0008577424
Unlock 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
Unlock Study Endpoints

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
Unlock Study Design Details

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
Unlock Eligibility Criteria