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Albuterol/salbutamol

Phase 4

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

Albuterol/salbutamol development status

Highest phase Phase 4 (NCT01691482)
Phase scored for GSKPhase 3
Registered trials 24 across 5 sponsors since Oct 2003

Albuterol/salbutamol target and mechanism

Molecular targetADRB2
Target classAgonist
ModalitySmall molecule
ChEMBLCHEMBL714

Also known as Albuterol, albuterol sulfate inhalation aerosol

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

Albuterol/salbutamol clinical trials

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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Frequently asked questions about Albuterol/salbutamol

What is albuterol/salbutamol used for?

Albuterol/salbutamol is used to treat asthma and acute wheezing caused by obstructive airways disease. It is a small molecule inhaled therapy developed by GSK plc (ticker: GSK) and is also known as albuterol sulfate inhalation aerosol. The drug is in Phase 3 clinical development for asthma.

What does albuterol/salbutamol target?

Albuterol/salbutamol targets ADRB2, the beta-2 adrenergic receptor. It acts as an agonist at this receptor. By activating ADRB2, the drug helps relax airway smooth muscle, which is relevant to its use in asthma and obstructive airways disease.

Who makes albuterol/salbutamol?

Albuterol/salbutamol is developed by GSK plc, which trades under the ticker GSK. GSK is the company responsible for the clinical development of this inhaled small molecule for asthma and related respiratory conditions.

What phase is albuterol/salbutamol in?

Albuterol/salbutamol is in Phase 3 clinical development. It is an investigational therapy and has not been approved by the FDA for the studied indication. The Phase 3 trial has been completed, and no active trials are currently listed.

What clinical trials is albuterol/salbutamol in?

Albuterol/salbutamol has been studied in one completed Phase 3 trial, NCT00144846, titled Inhaled Albuterol Sulfate For Acute Wheezing Due To Obstructive Airways Disease In Children. The trial enrolled 80 participants in the United States and Puerto Rico and included both randomized and double-blind design elements.

Is albuterol the same as salbutamol?

Yes, albuterol and salbutamol are the same drug. Albuterol/salbutamol is also known as albuterol, albuterol sulfate inhalation aerosol, and albuterol/salbutamol Metered Dose Inhaler (MDI). These names refer to the same active molecule developed by GSK plc.