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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01475045
First Posted: November 21, 2011
Last Update Posted: November 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.
  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:


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

Primary Outcome Measures:
  • Patients' satisfaction [ Time Frame: all study period (5 months) ]
    Patients' replies to FSI-10 questionnaire valid in Greek language


Secondary Outcome Measures:
  • Patients devices' use [ Time Frame: all study period (5 months) ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier: NCT01475045     History of Changes
Other Study ID Numbers: 20109-HAL-EL-02
Sponsor ID ( Other Identifier: Elpen Pharmaceutical Co Inc )
First Submitted: October 12, 2011
First Posted: November 21, 2011
Last Update Posted: November 21, 2011
Last Verified: November 2011

Keywords provided by Elpen Pharmaceutical Co. Inc.:
COPD

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