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Albuterol/salbutamol

Phase 3

Asthma | Small molecule | Respiratory |GSK plc|Last Updated: Sep 23, 2016

Target and mechanism

ModalitySmall molecule

Also known as Albuterol, albuterol sulfate inhalation aerosol, albuterol

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Albuterol/salbutamol · 1 trial · 1 indication

Phase 3 1
NCT00144846Inhaled Albuterol Sulfate For Acute Wheezing Due To Obstructive Airways Disease In ChildrenAsthma
COMPLETED80 Analytics
PHASE3COMPLETED
Inhaled Albuterol Sulfate For Acute Wheezing Due To Obstructive Airways Disease In Children
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate safety (adverse events, vital signs, physical exams, ECG monitoring etc.) of cumulative dosing of albuterol sulfate inhalation aerosol

Secondary Endpoints

To assess the efficacy measures (percent change from baseline over entire treatment period in the TAL score, respiratory rate, wheezing etc.) of cumulative dosing of albuterol sulfate inhalation aerosol.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1OTHER -

Interventions

NameTypeDescription
albuterol sulfate inhalation aerosolDRUG -
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Eligibility Criteria

Age RangeN/A to 23 Months
SexALL
Healthy VolunteersNo
Study Sites29

Inclusion criteria: * Must be an outpatient. * Age at second visit must be birth to \<24 months old. * Parent/guardian who is willing to sign, or has signed, an informed consent. * Must have acute wheezing consistent with reversible obstructive airway disease. * Must have an asthma symptoms score b...

Countries:United StatesPuerto Rico
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