AsthmaBALLOONNCT01708486
BALLOON (Corticosteroid/laBA inhaLers in adoLescents' Asthma: Assessment Of Patients satisfactiON) Study
An observational study of Asthma, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Asthma
- How many people
- 35 participants
- Where
- 1 siteGreece
- Study dates
- Feb 2013to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter, Prospective, Non-interventional, Observational Study on Treatment of Asthma in Children.
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.
Read the 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.
- Conditions
- Asthma
- Keywords
- asthma, Dry Powder Inhalers, FSI-10 questionnaire
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents' with asthma using inhalation devices | Asthmatic adolescents will record their opinion for their inhalation devices by replying to FSI-10 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feeling of satisfaction with inhalation devices in asthmatic children
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.
Measured: 2 months
Secondary outcomes (1)
FSI-10 questionnaire ratings' comparison for inhalation devices
The total score will be compared among devices. Each question grating will be also compared among devices.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startFeb 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ch Hatzimihael, MD Professor, Principal investigator, Democretion University of Alexandroupolis, Pediatric Department, Thrace, GreeceEmm Paraskakis, MD, Ass Professor, Principal investigator, Demokretion University of Alexandroupolis, Pediatric Department, Thrace, GreeceAth Kaditis, MD, Principal investigator, Agia Sofia Childrens Hospital of Athens, University Pediatric Clinic, Pulmonology DepartmentPoly Panayotopoulou, MD, Principal investigator, Agia Sofia Childrens Hospital of Athens, University Pediatric Clinic, Pulmonology DepartmentDimos Gidaris, MD Pulmonologist, Principal investigator, Hippokration Hospital of Thessaloniki, Scientific collaboratorMichael Anthrakopoulos, MD, Associate Professor, Principal investigator, University Hospital of Rio, Patras, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708486
- Sponsor's protocol ID
- 2011-FLUSAL-EL-24
- Acronym
- BALLOON
- Status last verified
- Aug 2014
- First submitted
- 15 Oct 2012
- Last updated
- 19 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Campbell JL, Kiebert GM, Partridge MR. Development of the satisfaction with inhaled asthma treatment questionnaire. Eur Respir J. 2003 Jul;22(1):127-34. doi: 10.1183/09031936.03.00097503.
PubMed 12882462Kozma CM, Slaton TL, Monz BU, Hodder R, Reese PR. Development and validation of a patient satisfaction and preference questionnaire for inhalation devices. Treat Respir Med. 2005;4(1):41-52. doi: 10.2165/00151829-200504010-00005.
PubMed 15725049Perpina Tordera M, Viejo JL, Sanchis J, Badia X, Cobos N, Picado C, Sobradillo V, Martinez Gonzalez del Rio J, Duce F, Munoz Cabrera L. [Assessment of patient satisfaction and preferences with inhalers in asthma with the FSI-10 Questionnaire]. Arch Bronconeumol. 2008 Jul;44(7):346-52. Spanish.
PubMed 18727886Epstein S, Maidenberg A, Hallett D, Khan K, Chapman KR. Patient handling of a dry-powder inhaler in clinical practice. Chest. 2001 Nov;120(5):1480-4. doi: 10.1378/chest.120.5.1480.
PubMed 11713123van der Palen J, Klein JJ, van Herwaarden CL, Zielhuis GA, Seydel ER. Multiple inhalers confuse asthma patients. Eur Respir J. 1999 Nov;14(5):1034-7. doi: 10.1183/09031936.99.14510349.
PubMed 10596686Reliability of the FSI-10 questionnaire for the assessment of the usability of drug inhalers in Greek patients. N. Grekas, A. Athanassiou, C. Iskos, D. Panagiotakos, A. Papataxiarchou, O. Porichi. Arch Hellen Med, 28(2), March-April 2011, 257-260.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Prospective, Non-interventional, Observational Study on Treatment of Asthma in Children.
- ClinicalTrials.gov ID
- NCT01708486
- Acronym / sponsor ID
- BALLOON / 2011-FLUSAL-EL-24
- Conditions
- Asthma
- Keywords
- asthma, Dry Powder Inhalers, FSI-10 questionnaire
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Elpen Pharmaceutical Co. Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 17 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents' with asthma using inhalation devices | – | –Asthmatic adolescents will record their opinion for their inhalation devices by replying to FSI-10 questionnaire |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
FSI-10 questionnaire ratings' comparison for inhalation devices
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
- Background: PubMed 12882462Campbell JL, Kiebert GM, Partridge MR. Development of the satisfaction with inhaled asthma treatment questionnaire. Eur Respir J. 2003 Jul;22(1):127-34. doi: 10.1183/09031936.03.00097503.
- Background: PubMed 15725049Kozma CM, Slaton TL, Monz BU, Hodder R, Reese PR. Development and validation of a patient satisfaction and preference questionnaire for inhalation devices. Treat Respir Med. 2005;4(1):41-52. doi: 10.2165/00151829-200504010-00005.
- Background: PubMed 18727886Perpina Tordera M, Viejo JL, Sanchis J, Badia X, Cobos N, Picado C, Sobradillo V, Martinez Gonzalez del Rio J, Duce F, Munoz Cabrera L. [Assessment of patient satisfaction and preferences with inhalers in asthma with the FSI-10 Questionnaire]. Arch Bronconeumol. 2008 Jul;44(7):346-52. Spanish.
- Background: PubMed 11713123Epstein S, Maidenberg A, Hallett D, Khan K, Chapman KR. Patient handling of a dry-powder inhaler in clinical practice. Chest. 2001 Nov;120(5):1480-4. doi: 10.1378/chest.120.5.1480.
- Background: PubMed 10596686van der Palen J, Klein JJ, van Herwaarden CL, Zielhuis GA, Seydel ER. Multiple inhalers confuse asthma patients. Eur Respir J. 1999 Nov;14(5):1034-7. doi: 10.1183/09031936.99.14510349.
- BackgroundReliability of the FSI-10 questionnaire for the assessment of the usability of drug inhalers in Greek patients. N. Grekas, A. Athanassiou, C. Iskos, D. Panagiotakos, A. Papataxiarchou, O. Porichi. Arch Hellen Med, 28(2), March-April 2011, 257-260.
- Reliability of the FSI-10 questionnaire for the assessmentof the usability of drug inhalers in Greek patientsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ch Hatzimihael, MD Professor principal investigator
Democretion University of Alexandroupolis, Pediatric Department, Thrace, Greece
Emm Paraskakis, MD, Ass Professor principal investigator
Demokretion University of Alexandroupolis, Pediatric Department, Thrace, Greece
Ath Kaditis, MD principal investigator
Agia Sofia Childrens Hospital of Athens, University Pediatric Clinic, Pulmonology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by Elpen Pharmaceutical Co. Inc. at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feeling of satisfaction with inhalation devices in asthmatic children (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01708486, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2014.