Lung Deposition Via Different Inhalation Devices | NCT00975754

Studies
Lung Deposition Via Different Inhalation Devices

NCT00975754

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Dec 11, 2009Estimated

Enrollment

16Estimated

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

Pulmicort pMDI HFA
Budesonide pMDI HFA
Pulmicort Repulses
Pulmicort Turbohaler

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Not provided

Completion Date

Nov 2009Actual

First Submitted Date

Sep 10, 2009

First Submission Date that Met QC Criteria

Sep 10, 2009

First Posted Date

Sep 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2009

Last Update Posted Date

Dec 11, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to assess the deposition of budesonide to the lung after inhalation with 5 different devices and to relate the findings to in vitro properties of inhaled budesonide.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Pulmicort pMDI	Drug: Pulmicort pMDI HFA
2	Experimental	Budesonide pMDI	Drug: Budesonide pMDI HFA
3	Experimental	Budesonide pMDI + Aerochamber Zero-stat spacer	Drug: Budesonide pMDI HFA
4	Experimental	Pulmicort repulses via Spira Nebuliser	Drug: Pulmicort Repulses
5	Experimental	Pulmicort Turbohaler	Drug: Pulmicort Turbohaler

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulmicort pMDI HFA	Drug	Inhalation aerosol, 200 μg/ metered dose. Each subject receive a single dose from 4 inhalations	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lung deposition of budesonide (AUC)		Before dose and repeatadly during the 8-hour period after dose

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 glucocorticosteroids, inhaled lactose, or other excipients in study drugs

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carin Jorup	AstraZeneca R&D Lund, Sweden	Study Director
Pia Lena Berg	Clinical Pharmacology Unit, AstraZeneca R&D Lund, Sweden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Lund			Sweden

Condition Browse Module

MeSH Terms

ID	Term
D053120	Respiratory Aspiration

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided