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AS MDI

Phase 2

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

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

AS MDI · 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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Frequently asked questions about AS MDI

What is AS MDI used for in asthma?

AS MDI is an investigational small molecule being developed for the treatment of asthma. It is a pressurized inhalation suspension of albuterol sulfate, intended for use in patients with asthma. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes AS MDI?

AS MDI is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for the treatment of asthma.

What phase is AS MDI in?

AS MDI is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of asthma, and its clinical development is ongoing.

What clinical trials is AS MDI in?

AS MDI has one completed Phase 2 clinical trial, identified as NCT03371459. This trial assessed the safety, efficacy, pharmacokinetics, and extrapulmonary pharmacodynamics of AS MDI compared to Proventil as an active control in subjects with asthma. The trial enrolled 46 participants in the United States.

How does AS MDI work?

AS MDI contains albuterol sulfate, a bronchodilator that works by relaxing the muscles in the airways to improve breathing. It is administered as a pressurized inhalation suspension, delivering the medication directly to the lungs to relieve asthma symptoms.

Is AS MDI the same as albuterol sulfate?

AS MDI is a formulation of albuterol sulfate delivered as a pressurized inhalation suspension. It is being developed as an alternative to existing albuterol products, such as Proventil, which was used as an active control in its clinical trial. The drug is not yet approved.