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Albuterol dry inhaler

Phase 1

Asthma | Small molecule | Respiratory |Teva Pharmaceutical Industries Limited|Trials Updated: Feb 2, 2022

Albuterol dry inhaler target and mechanism

Molecular targetADRB2
Target classAgonist
ModalitySmall molecule
ChEMBLCHEMBL714

Also known as Albuterol dry powder inhaler

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment47

FDA Designations

No designations recorded

Albuterol dry inhaler clinical trials

Albuterol dry inhaler · 1 trial · 1 indication

Phase 1 1
NCT01056159A Cumulative Dose Study to Evaluate the Safety and Efficacy of Albuterol in a Dry Powder Inhaler and an HFA MDI (Hydrofluoroalkane Metered Dose Inhaler)Asthma
COMPLETED47 Analytics
PHASE1COMPLETED
A Cumulative Dose Study to Evaluate the Safety and Efficacy of Albuterol in a Dry Powder Inhaler and an HFA MDI (Hydrofluoroalkane Metered Dose Inhaler)
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Study Endpoints

Primary Endpoints

Baseline-adjusted forced expiratory volume in one second (FEV1) 30 minutes after each of the five cumulative doses
At the two study treatment visits, FEV1 (forced expiratory volume in 1 second) will be measured prior to drug administration and 5 times, once at 30 minutes after each of the 5 doses.

Secondary Endpoints

Baseline-adjusted FEV1 (forced expiratory volume in 1 second) AUC0-6 (area under the serum concentration time curve from time 0 to 6 hours) following the administration of the final cumulative dose
At the two study treatment visits, FEV1 (forced expiratory volume in 1 second) will be measured prior to drug administration and 7 time points ( 30 minutes and 1,2,3,4,5 and 6 hours) after the 5th and final dose.
ECGs (electrocardiogram) will assess the maximum and mean change from baseline of the corrected QT interval (QT interval measures the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle) following study drug.
Serial ECGs (electrocardiogram) will be taken at baseline (5 minutes pre-dose), 15 minutes after each dose, and also at 30 minutes, 60 minutes, 2, 3, and 4 hours following the last cumulative dose in order to calculate the corrected QT interval.
Changes in blood pressure will be evaluated by the maximum change (systolic) and minimum change (diastolic) from baseline blood pressure, and the weighted mean change from baseline in systolic and diastolic blood pressure.
Serial measurements of systolic and diastolic blood pressure will be taken at baseline (15 minutes pre-dose), 15 minutes after each dose, and also at 30 minutes, 60 minutes, 2, 3, 4, 5, and 6 hours following the last cumulative dose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Albuterol dry powder inhalerEXPERIMENTALThe participants will receive albuterol delivered with the a DPI (dry powder inhaler) and placebo with an HFA MDI inhaler (hydrofluoroalkane metered dose inhaler).
Albuterol HFA MDIACTIVE_COMPARATORThe participants will receive albuterol delivered with an HFA MDI inhaler (hydrofluoroalkane metered dose inhaler) and placebo with albuterol in a DPI (dry powder inhaler).

Interventions

NameTypeDescription
Albuterol dry powder inhalerDRUGAlbuterol DPI (dry powder inhaler) delivers 90mcg of albuterol in the excipient lactose with each inhalation. Albuterol will be given on two treatment days (3 to 14 days apart). On each treatment day albuterol will be given as a cumulative dose of 1440mcg as a series of inhalations using both Albuterol in a DPI (dry Powder inhaler) and albuterol in an HFA MDI (hydrofluoroalkane metered dose inhaler), ProAir. One inhaler will contain active drug and one inhaler will contain placebo.
Albuterol HFA MDI (hydrofluoroalkane metered dose inhaler)DRUGAlbuterol HFA MDI (hydrofluoroalkane metered dose inhaler) delivers 90mcg of albuterol with each inhalation. Albuterol will be given on two treatment days (3to 14 days apart). On each treatment day albuterol will be given as a cumulative dose of 1440mcg as a series of inhalations using both Albuterol DPI (dry powder inhaler) and the comparator inhaler, albuterol HFA MDI (hydrofluoroalkane metered dose inhaler).One inhaler will contain active drug and one inhaler will contain placebo.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Must provide written informed consent, * Must be between 18-45 years of age, * Male or Female, females of non-child bearing potential or using reliable contraception * Asthma for at least 6 months, FEV1 (forced expiratory volume in 1 second) between 50-80% of predicted value, ...

Countries:United States
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Frequently asked questions about Albuterol dry inhaler

What is albuterol dry inhaler?

Albuterol dry inhaler is an investigational dry powder formulation of albuterol, a small molecule bronchodilator being developed by Teva Pharmaceutical Industries Limited for asthma. It is delivered as a dry powder rather than as a liquid aerosol, and it is in Phase 1 clinical development.

What is albuterol dry inhaler used for?

Albuterol dry inhaler is being studied for the treatment of asthma. The single reported trial enrolled adults with asthma in the United States. Because the program remains in Phase 1, the formulation is investigational and has not been established as a marketed treatment option for asthma.

What does albuterol dry inhaler target?

Albuterol dry inhaler targets ADRB2, the beta-2 adrenergic receptor. It acts as an agonist at this receptor, which is the same target class as conventional albuterol products. The dry powder formulation is designed to deliver the same active small molecule through a different inhalation device.

Who makes albuterol dry inhaler?

Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA, is the developer of the albuterol dry powder inhaler. The company sponsored the Phase 1 study that evaluated the formulation in adults with asthma.

What phase is albuterol dry inhaler in?

Albuterol dry inhaler is in Phase 1 development. It is an investigational product and is not described as approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for this formulation.

What clinical trials is albuterol dry inhaler in?

Albuterol dry inhaler has been studied in one completed Phase 1 trial, NCT01056159, titled A Cumulative Dose Study to Evaluate the Safety and Efficacy of Albuterol in a Dry Powder Inhaler and an HFA MDI. It was randomized, double blind, active controlled, enrolled 47 adults with asthma in the United States, and has completed.

Is albuterol dry inhaler the same as albuterol dry powder inhaler?

Yes, albuterol dry inhaler and albuterol dry powder inhaler refer to the same product. Both names describe the Teva Pharmaceutical Industries Limited formulation that delivers albuterol as a dry powder for inhalation in asthma.