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Pulmicort pMDI HFA

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: Dec 11, 2009

Pulmicort pMDI HFA development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Pulmicort pMDI HFA clinical trials

Pulmicort pMDI HFA · 1 trial · 1 indication

Phase 1 1
NCT00975754Lung Deposition Via Different Inhalation DevicesHealthy Volunteers
COMPLETED16 Analytics
PHASE1COMPLETED
Lung Deposition Via Different Inhalation Devices
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Study Endpoints

Primary Endpoints

Lung deposition of budesonide (AUC)
Before dose and repeatadly during the 8-hour period after dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1EXPERIMENTALPulmicort pMDI
2EXPERIMENTALBudesonide pMDI
3EXPERIMENTALBudesonide pMDI + Aerochamber Zero-stat spacer
4EXPERIMENTALPulmicort repulses via Spira Nebuliser
5EXPERIMENTALPulmicort Turbohaler

Interventions

NameTypeDescription
Pulmicort pMDI HFADRUGInhalation aerosol, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations
Budesonide pMDI HFADRUGInhalation aerosol, 160 μg/ metered dose. Each subject receive a single dose from 4 inhalations
Pulmicort RepulsesDRUGSuspension for nebulisation, 0.5 mg/mL. Each subject receive a single dose from 100 inhalations
Pulmicort TurbohalerDRUGInhaled powder, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of informed consent prior to any study specific procedures * BMI between 18 and 30 kg/m2 * Non-smokers/non-snuffers Exclusion Criteria: * Pregnant and/or lactating women * Use of oral contraceptives or hormonal implants * Known or suspected hypersensitivity to gluc...

Countries:Sweden
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Frequently asked questions about Pulmicort pMDI HFA

What is Pulmicort pMDI HFA?

Pulmicort pMDI HFA is an investigational pressurized metered dose inhaler formulation developed by AstraZeneca PLC. It is a small molecule product delivered by inhalation and has been studied in a Phase 1 trial in healthy volunteers. Its specific therapeutic indications have not been disclosed.

Who makes Pulmicort pMDI HFA?

Pulmicort pMDI HFA is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program for this inhaled product.

What phase is Pulmicort pMDI HFA in?

Pulmicort pMDI HFA is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. It is an investigational product and is not described as approved by the FDA.

What clinical trials is Pulmicort pMDI HFA in?

Pulmicort pMDI HFA has been studied in one completed Phase 1 trial, NCT00975754, titled Lung Deposition Via Different Inhalation Devices. The trial enrolled 16 healthy volunteers in Sweden, was randomized and controlled, and included participants aged 18 years and older of all sexes.

What is Pulmicort pMDI HFA used for?

The therapeutic indications for Pulmicort pMDI HFA have not been disclosed. The completed Phase 1 trial, NCT00975754, evaluated lung deposition via different inhalation devices in healthy volunteers rather than in a patient population with a specific disease.

How is Pulmicort pMDI HFA administered?

Pulmicort pMDI HFA is administered by inhalation as a pressurized metered dose inhaler. Its completed Phase 1 trial, NCT00975754, compared lung deposition via different inhalation devices, which reflects the inhaled route of delivery for this small molecule product.