ANASA (Patients' Satisfaction With Pulmonary Diseases' Tr... | NCT01475045

Studies
ANASA (Patients' Satisfaction With Pulmonary Diseases' Treatment)

NCT01475045

Sponsor

Elpen Pharmaceutical Co. Inc.

Status

Completed

Last Update Posted

Nov 21, 2011Estimated

Enrollment

1,160Actual

Phase

Not provided

Conditions

Asthma
Chronic Obstructive Pulmonary Disease

Interventions

Not provided

Countries

Greece

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

ID	Type	Description	Link
Sponsor ID	Other Identifier	Elpen Pharmaceutical Co Inc

Status Module

Record Verification Date

Nov 2011

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

Jan 2011

Primary Completion Date

Apr 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Oct 12, 2011

First Submission Date that Met QC Criteria

Nov 18, 2011

First Posted Date

Nov 21, 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

Nov 18, 2011

Last Update Posted Date

Nov 21, 2011Estimated

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 compare patients' satisfaction from the use of three different inhalation devices by using the FSI-10 questionnaire

Detailed Description

Patients are requested to reply to FSI-10 questionnaire regarding their satisfaction from inhalation devices. Patients are on 3 different asthma inhalation devices with combination treatment (Turbuhaler, Diskus, Elpenhaler)

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,160Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patients' satisfaction	Patients' replies to FSI-10 questionnaire valid in Greek language	all study period (5 months)

Secondary Outcomes

Measure	Description	Time Frame
Patients devices' use		all study period (5 months)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients > 18 years old, both genders who are on their inhalation treatment at least two months before study enrollment,
Who are able to be compliant to study procedures

Exclusion Criteria:

Patients < 18 years old,
Patients who are on their inhalation treatment less than two months before study enrollment
Patients who are not able to be compliant to study procedures

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Three subgroups of patients who are already in their inhalation treatment (devices: Discus, Elpenhaler, Turbuhaler) are asked to complete the FSI-10 questionnaire valid in Greek language. The questionnaire responses indicate their satisfaction by their treatment devices.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Asimina Gaga	7th Pulmonary Clinic, Sotiria Hospital of Athens	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
7th Pulmonary Clinic, Sotiria Hospital		Athens			Greece
Sotiria Hospital

References Module

Citations

Not provided

Label	Type	Description	Intervention Names
Turbuhaler inhaler use
Discus inhaler use
Elpenhaler inhaler use

Label	URL
study design presented in European Respiratory Congress (2 thematric posters)	View source
FSI-10 questionnaire has been translated and is valid in Greek language (full article)	View source

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