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ANASA (Patients' Satisfaction With Pulmonary Diseases' Treatment)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier:
NCT01475045
First received: October 12, 2011
Last updated: November 18, 2011
Last verified: November 2011
History of Changes
  Purpose

The aim of the study is to compare patients' satisfaction from the use of three different inhalation devices by using the FSI-10 questionnaire


Condition
Asthma
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Multicenter, Prospective, Non Interventional Observational Study in Treatments of Asthma and Chronic Obstructive Pulmonary Disease (COPD)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Elpen Pharmaceutical Co. Inc.:

Primary Outcome Measures:
  • Patients' satisfaction [ Time Frame: all study period (5 months) ] [ Designated as safety issue: No ]
    Patients' replies to FSI-10 questionnaire valid in Greek language


Secondary Outcome Measures:
  • Patients devices' use [ Time Frame: all study period (5 months) ] [ Designated as safety issue: No ]

Enrollment: 1160
Study Start Date: January 2011
Study Completion Date: September 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Turbuhaler inhaler use
Discus inhaler use
Elpenhaler inhaler use

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability 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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475045

Locations
Greece
7th Pulmonary Clinic, Sotiria Hospital
Athens, Greece
Sotiria Hospital
Athens, Greece
Sponsors and Collaborators
Elpen Pharmaceutical Co. Inc.
Investigators
Principal Investigator: Asimina Gaga 7th Pulmonary Clinic, Sotiria Hospital of Athens
  More Information

Additional Information:
study design presented in European Respiratory Congress (2 thematric posters)  This link exits the ClinicalTrials.gov site
FSI-10 questionnaire has been translated and is valid in Greek language (full article)  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier: NCT01475045     History of Changes
Other Study ID Numbers: 20109-HAL-EL-02, Sponsor ID
Study First Received: October 12, 2011
Last Updated: November 18, 2011
Health Authority: Greece: National Organization of Medicines

Keywords provided by Elpen Pharmaceutical Co. Inc.:
COPD

Additional relevant MeSH terms:
Asthma
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
 Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013