NCT01475045

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,160

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 12, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 21, 2011

Completed
Last Updated

November 21, 2011

Status Verified

November 1, 2011

Enrollment Period

3 months

First QC Date

October 12, 2011

Last Update Submit

November 18, 2011

Conditions

AsthmaChronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

  • Patients' satisfaction

    Patients' replies to FSI-10 questionnaire valid in Greek language

    all study period (5 months)

Secondary Outcomes (1)

  • Patients devices' use

    all study period (5 months)

Study Arms (3)

Turbuhaler inhaler use

Discus inhaler use

Elpenhaler inhaler use

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

7th Pulmonary Clinic, Sotiria Hospital

Athens, Greece

Location

Sotiria Hospital

Athens, Greece

Location

Related Links

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Asimina Gaga

    7th Pulmonary Clinic, Sotiria Hospital of Athens

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2011

First Posted

November 21, 2011

Study Start

January 1, 2011

Primary Completion

April 1, 2011

Study Completion

September 1, 2011

Last Updated

November 21, 2011

Record last verified: 2011-11

Locations

GR(2)