BALLOON (Corticosteroid/laBA inhaLers in adoLescents' Asthma: Assessment Of Patients satisfactiON) Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Elpen Pharmaceutical Co. Inc.
Sponsor:
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier:
NCT01708486
First received: October 15, 2012
Last updated: September 23, 2013
Last verified: March 2013
  Purpose

Patients' satisfaction with their asthma medication devices is usually decided by using properly designed questionnaires. These questionnaires are to be used to evaluate patients' opinion, which is considered very important for the selection of a device.

The Feeling of Satisfaction with Inhaler (FSI-10) is a self-completed questionnaire designed to assess the patient opinion regarding the satisfaction and usability of the inhalers irrespectively of the drug used. It consists of 10 question each with 5 possible responses on a 5-point Likert scale scored from 5 to 1, respectively. The total score can range between 10 and 50. The higher the score, the higher the feeling of patient satisfaction from the inhaler.


Condition
Asthma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Multicenter, Prospective, Non-interventional, Observational Study on Treatment of Asthma in Children.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Feeling of satisfaction with inhalation devices in asthmatic children [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    FSI-10 questionnaire rating per inhalation device. FSI-10 consists of 10 questions with 5 possible responses on a 5-point Likert scale scored from 5 to 1,respectively. The total score can range between 10 and 50. The higher the score, the higher the feeling of patient satisfaction from the inhaler.


Secondary Outcome Measures:
  • FSI-10 questionnaire ratings' comparison for inhalation devices [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
    The total score will be compared among devices. Each question grating will be also compared among devices.


Estimated Enrollment: 180
Study Start Date: February 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adolescents' with asthma using inhalation devices
Asthmatic adolescents will record their opinion for their inhalation devices by replying to FSI-10 questionnaire

Detailed Description:

Childhood and adolescents' asthma is the most common chronic disease of childhood and is the major cause of absenteeism from school students. To deal with the disease often require hospitalization, fortunately, very rare enough to be life-threatening. Since the mid-80s had clearly expressed by several centers to observe the rising incidence of the disease. The next year observation was confirmed many times. Childhood asthma has been characterized as a disease of modern Western civilization. It affects a large proportion of the child population and seems to take longer epidemic character.

From studies carried out recently in Greece found that children of school age asthmatic type symptoms during the past 12 months appear to 5-10% of pupils. The rates are doubled when the question is not limited to the last 12 months. Also in a study involving 2133 children aged 7 and 18 years, the prevalence of asthma was 7.7% and 4.7% (at the age of 7 and 18 years respectively) and chronic asthma 19.6% and 26.3% (at the age of 7 and 18 years, respectively), while over half of the children (58.2%) with early asthma (asthma diagnosed before age 7) had no symptoms at the age of 7. At the age of 18 still had symptoms for 7.6% of children with early asthma and 48.2% of children who developed asthma between 7-18 years (6.7% of study participants).

For the onset of childhood asthma synergize two factors: genetic, ie heredity, and environmental, that is the environment in which we live. There is a predisposition for the disease and the environment favors the onset. So to increase the prevalence implicated: a) genetic predisposition, b) the method of construction of houses, c) smoking (assets - liabilities), c) indoor pollution, d) atmospheric pollution, e) the modern way of eating and clothing and f) preventing illness by a large number of serious infections due to the widespread use of vaccines.Most asthma medications are administered using suitable inhalers. There are various types of devices that facilitate the administration of inhaled medications in young children. The correct use of inhalational devices is very important for the treatment of asthma. If the patient does not understand the instructions, the drug is deposited satisfactorily lungs, ie organ must act, so there is no remission.

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

180 asthmatic adolescents (60 per device) aged 12-18 years using their inhalation device at least one month before study enrolment. This will be a real-life, regular clinical practice assesment.

Criteria

Inclusion Criteria:

  • Patients with history of asthma or newly diagnosed
  • Patient who are on their inhalation device treatment at least one month before study enrolment
  • Patients Male and Female
  • Patients' Age: 12-18 years
  • Patients who are familiar with their inhalation device
  • Patients with correct use of any individual inhalation device
  • Patients who will follow all study procedures
  • Patients who agree to record their evaluation in written by filling in the FSI-10 questionnaire

Exclusion Criteria:

  • Patient who are on their inhalation device treatment less than one month before study enrolment
  • Patients' Age: <12, >18 years
  • Patients with incorrect use of any individual inhalation device
  • Patients with no sufficient treatment compliance
  • Patients with no sufficient study procedures' compliance
  • Patients who do not agree to record their evaluation in written by filling in the FSI-10 questionnaire
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708486

Contacts
Contact: John Tsanakas, MD, Professor tsanakasj@ath.forthnet.gr

Locations
Greece
Hippokrateion University Hospital Recruiting
Thessaloniki, Greece
Principal Investigator: Ioannis Tsanakas, MD Professor         
Sponsors and Collaborators
Elpen Pharmaceutical Co. Inc.
Investigators
Principal Investigator: Ch Hatzimihael, MD Professor Democretion University of Alexandroupolis, Pediatric Department, Thrace, Greece
Principal Investigator: Emm Paraskakis, MD, Ass Professor Demokretion University of Alexandroupolis, Pediatric Department, Thrace, Greece
Principal Investigator: Ath Kaditis, MD Agia Sofia Childrens Hospital of Athens, University Pediatric Clinic, Pulmonology Department
Principal Investigator: Poly Panayotopoulou, MD Agia Sofia Childrens Hospital of Athens, University Pediatric Clinic, Pulmonology Department
Principal Investigator: Dimos Gidaris, MD Pulmonologist Hippokration Hospital of Thessaloniki, Scientific collaborator
Principal Investigator: Michael Anthrakopoulos, MD, Associate Professor University Hospital of Rio, Patras, Greece
  More Information

Additional Information:
Publications:
Responsible Party: Elpen Pharmaceutical Co. Inc.
ClinicalTrials.gov Identifier: NCT01708486     History of Changes
Other Study ID Numbers: 2011-FLUSAL-EL-24
Study First Received: October 15, 2012
Last Updated: September 23, 2013
Health Authority: Greece: National Organization of Medicines

Keywords provided by Elpen Pharmaceutical Co. Inc.:
asthma
Dry Powder Inhalers
FSI-10 questionnaire

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

ClinicalTrials.gov processed this record on July 29, 2014