Inspiratory Flow Parameters of Easyhaler and Diskus Inhal... | NCT01424137

Studies
Inspiratory Flow Parameters of Easyhaler and Diskus Inhalers (SALIF)

NCT01424137

Sponsor

Orion Corporation, Orion Pharma

Status

Completed

Last Update Posted

Feb 3, 2012Estimated

Enrollment

227Actual

Phase

Not Applicable

Conditions

Asthma
Chronic Obstructive Pulmonary Disease

Interventions

Easyhaler type A
Easyhaler type B
Diskus inhaler

Countries

Estonia
Finland

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

Feb 2012

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 2011

Primary Completion Date

Nov 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Aug 24, 2011

First Submission Date that Met QC Criteria

Aug 25, 2011

First Posted Date

Aug 26, 2011Estimated

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

Feb 2, 2012

Last Update Posted Date

Feb 3, 2012Estimated

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 characterise inspiratory flow parameters across 2 Easyhaler® (EH) inhaler versions and Diskus® inhaler in patients with asthma (including children, adults, and the elderly) and in patients with chronic obstructive pulmonary disease (COPD).

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

227Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Easyhaler type A	Other	Device: Easyhaler type A
Easyhaler type B	Other	Device: Easyhaler type B
Diskus inhaler	Other	Device: Diskus inhaler

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Easyhaler type A	Device	Easyhaler type A inhaler, 3 consecutive inhalations	Easyhaler type A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak inspiratory flow rate through the placebo Easyhaler and Diskus inhalers		1 day

Secondary Outcomes

Measure	Description	Time Frame
The inspiratory volume through the placebo Easyhaler and Diskus inhalers will be measured at the same time with the peak inspiratory flow rate		1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent (IC) obtained
Documented diagnosis of asthma and/or COPD
Age: 4 years and above

Exclusion Criteria:

Any severe chronic respiratory disease other than asthma or COPD
Acute respiratory infection
Any medical condition that in the opinion of the investigator would endanger the subject if he/she participates in the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 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
Kati Kaijasilta	Orion Corporation, Orion Pharma	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lasnamäe Medicum		Tallinn		13619	Estonia
Children's Clinic of Tartu, Allergy Centre

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38170393	Derived	Kainu A, Vartiainen VA, Mazur W, Hisinger-Molkanen H, Lavorini F, Janson C, Andersson M. Successful Use of Easyhaler(R) Dry Powder Inhaler in Patients with Chronic Obstructive Pulmonary Disease; Analysis of Peak Inspiratory Flow from Three Clinical Trials. Pulm Ther. 2024 Mar;10(1):133-142. doi: 10.1007/s41030-023-00246-8. Epub 2024 Jan 3.

ID	Term
D001249	Asthma
D029424	Pulmonary Disease, Chronic Obstructive

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