Inspiratory Flow Parameters and Handling of Easyhaler and... | NCT00984906

Studies
Inspiratory Flow Parameters and Handling of Easyhaler and Turbuhaler Inhalers

NCT00984906

Sponsor

Orion Corporation, Orion Pharma

Status

Completed

Last Update Posted

Jun 8, 2010Estimated

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Asthma
Pulmonary Disease, Chronic Obstructive

Interventions

Empty inhalers

Countries

Finland
United Kingdom

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

Jun 2010

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

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Sep 23, 2009

First Submission Date that Met QC Criteria

Sep 24, 2009

First Posted Date

Sep 25, 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

Jun 7, 2010

Last Update Posted Date

Jun 8, 2010Estimated

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 aim of the study is to measure the inspiratory flow that the different patient groups (asthmatic children, adults and elderly, as well as chronic obstructive pulmonary disease (COPD) patients) generate through empty Easyhaler (two versions) and Turbuhaler inhalers. In addition, the handling and acceptability of the inhalers will be compared in asthmatic children.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Empty Easyhaler type A	Other	Other: Empty inhalers
Empty Easyhaler type B	Other	Other: Empty inhalers
Empty Turbohaler	Other	Other: Empty inhalers

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Empty inhalers	Other	Empty Easyhaler inhalers (type A and type B) and empty Turbohaler inhaler	Empty Easyhaler type A Empty Easyhaler type B Empty Turbohaler

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak inspiratory flow rate through the empty Easyhaler and Turbohaler inhalers		1 Day

Secondary Outcomes

Measure	Description	Time Frame
Other inspiratory flow parameters through the empty Easyhaler and Turbohaler inhalers measured at the same time with the peak inspiratory flow rate.		1 Day
Handling of the devices in the subpopulation of asthmatic children		1 Day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent obtained.
Documented diagnosis of asthma and/or COPD (a range of different severities for both diseases).
Age: 6 years or above.

Exclusion Criteria:

Any severe chronic respiratory disease other than asthma or COPD.
Acute respiratory infection.
Concurrent participation in a clinical drug study.
Inability to perform repeatable spirometric measurements.
Any medical condition that in the opinion of the investigator would endanger the subject if he/she participates in the study (such as contraindications to spirometry).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Satu Lähelmä, M.Sc.(Pharm)	Orion Corporation, Orion Pharma	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jorvi hospital		Helsinki			Finland
Skin and Allergy hospital

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided