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PT007

Phase 2

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Jul 23, 2019

Target and mechanism

ModalitySmall molecule

Also known as AS MDI, Albuterol sulfate metered dose inhaler, MDI, Albuterol metered dose inhaler, MDI

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

PT007 · 1 trial · 1 indication

Phase 2 1
NCT03371459Assessment of the Safety, Efficacy, PK, and Extrapulmonary Pharmacodynamics (PD) of Albuterol Sulfate Pressurized Inhalation Suspension (Hereafter Referred to as AS MDI) Compared to Proventil as an Active Control in Subjects With AsthmaAsthma
COMPLETED46 Analytics
PHASE2COMPLETED
Assessment of the Safety, Efficacy, PK, and Extrapulmonary Pharmacodynamics (PD) of Albuterol Sulfate Pressurized Inhalation Suspension (Hereafter Referred to as AS MDI) Compared to Proventil as an Active Control in Subjects With Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Baseline-adjusted FEV1 30 Minutes After Each Cumulative Dose
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

Forced expiratory volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation

Secondary Endpoints

Baseline-adjusted FEV1 AUC0-6 After the Last Cumulative Dose
Over 6 hours post dose on Day 1
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AS MDIEXPERIMENTALAS MDI 1+1+2+4+8 inhalations of 90 μg per inhalation
ProventilACTIVE_COMPARATORProventil 1+1+2+4+8 inhalations of 90 μg per inhalation

Interventions

NameTypeDescription
AS MDIDRUGAS MDI 1+1+2+4+8 inhalations of 90 μg per inhalation
ProventilDRUGProventil 1+1+2+4+8 inhalations of 90 μg per inhalation
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Have stable (for 6 months) physician-diagnosed asthma with historical documentation of the diagnosis * Must be receiving 1 of the following required inhaled asthma therapies listed below for at least the last 30 days; Only SABA, which is used as needed for rescue, or Low to me...

Countries:United States
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