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

Sponsor

Elpen Pharmaceutical Co. Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01708486

Collaborator

(none)

Enrollment

Location

15.9

Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Asthma

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.

Study Design

Study Type:

Observational

Actual Enrollment :

35 participants

Time Perspective:

Prospective

Official Title:

Multicenter, Prospective, Non-interventional, Observational Study on Treatment of Asthma in Children.

Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Adolescents' with asthma using inhalation devices Asthmatic adolescents will record their opinion for their inhalation devices by replying to FSI-10 questionnaire

Outcome Measures

Primary Outcome Measures

Feeling of satisfaction with inhalation devices in asthmatic children [2 months]
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 [2 months]
The total score will be compared among devices. Each question grating will be also compared among devices.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hippokrateion University Hospital	Thessaloniki		Greece

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