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PT007

Phase 3

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

PT007 development status

Highest phase Phase 3 (NCT05555290)
Phase scored for AZNPhase 2
Registered trials 3 across 1 sponsor since Dec 2017

PT007 target and mechanism

ModalitySmall molecule

Also known as AS 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

PT007 clinical trials

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
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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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Frequently asked questions about PT007

What is PT007 used for?

PT007 is an investigational inhaled therapy being studied for the treatment of asthma. It is a small molecule delivered as a metered dose inhaler and has been evaluated in a Phase 2 clinical trial in adults with asthma. It is not described as an approved treatment.

Who is developing PT007?

PT007 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. The company sponsored the Phase 2 study of the asset in asthma, which was conducted in the United States.

What phase is PT007 in?

PT007 is in Phase 2 development. One Phase 2 trial in asthma has been completed, and no active trials of PT007 are currently listed. The program remains investigational and has not been described as approved by the FDA.

What clinical trial has studied PT007?

PT007 has been studied in NCT03371459, a completed Phase 2 trial titled Assessment of the Safety, Efficacy, PK, and Extrapulmonary Pharmacodynamics (PD) of Albuterol Sulfate Pressurized Inhalation Suspension Compared to Proventil as an Active Control in Subjects With Asthma. The trial enrolled 46 adults in the United States.

Is PT007 the same as AS MDI or albuterol metered dose inhaler?

Yes. PT007 is also known as AS MDI, albuterol sulfate metered dose inhaler, and albuterol metered dose inhaler. These names refer to the same AstraZeneca asset, an inhaled small molecule formulation studied in asthma under the NCT03371459 Phase 2 trial.

How was the PT007 asthma trial designed?

NCT03371459 was a randomized, active-controlled Phase 2 trial of PT007 in adults with asthma, with Proventil serving as the active control. It enrolled 46 participants, was not double-blind, and did not select patients by biomarker. The study has been completed.