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Pulmicort pMDI HFA

Phase 1

Healthy Volunteers | Small molecule | Other |AstraZeneca PLC|Last Updated: Dec 11, 2009

Success Probability

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

Pulmicort pMDI HFA is an investigational small molecule being studied in healthy volunteers. It is a pressurized metered-dose inhaler formulation of budesonide, a corticosteroid. The drug is being evaluated for lung deposition characteristics, though it is not approved for any specific indication and remains in clinical development.

Who makes Pulmicort pMDI HFA?

Pulmicort pMDI HFA is developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical research on this inhaled formulation to assess its deposition in the lungs.

What phase is Pulmicort pMDI HFA in?

Pulmicort pMDI HFA is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still being studied for its safety and deposition profile in healthy volunteers.

What clinical trials is Pulmicort pMDI HFA in?

Pulmicort pMDI HFA has one completed Phase 1 clinical trial registered under NCT00975754, titled "Lung Deposition Via Different Inhalation Devices." The study enrolled 16 healthy volunteers in Sweden, with participants aged 18 years and older. The trial was controlled but not double-blinded.

Is Pulmicort pMDI HFA the same as Pulmicort?

Pulmicort pMDI HFA is a specific pressurized metered-dose inhaler formulation of budesonide, the active ingredient in the Pulmicort brand. The "pMDI HFA" designation refers to the delivery device and propellant used. It is being studied for lung deposition in healthy volunteers.