Asthma Clinical Trial
— BALLOONOfficial title:
Multicenter, Prospective, Non-interventional, Observational Study on Treatment of Asthma in Children.
Verified date | August 2014 |
Source | Elpen Pharmaceutical Co. Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: National Organization of Medicines |
Study type | Observational |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years to 18 Years |
Eligibility |
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 |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Greece | Hippokrateion University Hospital | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Elpen Pharmaceutical Co. Inc. |
Greece,
Campbell JL, Kiebert GM, Partridge MR. Development of the satisfaction with inhaled asthma treatment questionnaire. Eur Respir J. 2003 Jul;22(1):127-34. — View Citation
Epstein 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. — View Citation
Kozma 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. — View Citation
Perpiñá Tordera M, Viejo JL, Sanchis J, Badia X, Cobos N, Picado C, Sobradillo V, Martínez González del Río J, Duce F, Muñoz 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. — View Citation
Reliability 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.
van 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 2 months | Yes |
Secondary | 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. | 2 months | Yes |
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