BALLOON (Corticosteroid/laBA inhaLers in adoLescents' Asthma: Assessment Of Patients satisfactiON) Study (BALLOON)
|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.|
|ClinicalTrials.gov Identifier: NCT01708486|
Recruitment Status : Completed
First Posted : October 17, 2012
Last Update Posted : August 19, 2014
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|
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 Type :||Observational|
|Actual Enrollment :||35 participants|
|Official Title:||Multicenter, Prospective, Non-interventional, Observational Study on Treatment of Asthma in Children.|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
Adolescents' with asthma using inhalation devices
Asthmatic adolescents will record their opinion for their inhalation devices by replying to FSI-10 questionnaire
- Feeling of satisfaction with inhalation devices in asthmatic children [ Time Frame: 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.
- FSI-10 questionnaire ratings' comparison for inhalation devices [ Time Frame: 2 months ]The total score will be compared among devices. Each question grating will be also compared among devices.
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): NCT01708486
|Hippokrateion University Hospital|
|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|