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

NCT01708486 | Completed

• 1 other identifier: 2011-FLUSAL-EL-24
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

asthma; Dry Powder Inhalers; FSI-10 questionnaire

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• FSI-10 questionnaire ratings' comparison for inhalation devices

  2 months

Study Arms (1)

Adolescents' with asthma using inhalation devices

Asthmatic adolescents will record their opinion for their inhalation devices by replying to FSI-10 questionnaire

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Study Sites (1)

Hippokrateion University Hospital

Thessaloniki, Thessaloniki, Greece

Location

Related Publications (6)

• 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.

  PMID: 12882462 BACKGROUND

• 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. doi: 10.2165/00151829-200504010-00005.

  PMID: 15725049 BACKGROUND

• Perpina 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.

  PMID: 18727886 BACKGROUND

• 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. doi: 10.1378/chest.120.5.1480.

  PMID: 11713123 BACKGROUND

• 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. doi: 10.1183/09031936.99.14510349.

  PMID: 10596686 BACKGROUND

• 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.

  BACKGROUND

Related Links

• Reliability of the FSI-10 questionnaire for the assessmentof the usability of drug inhalers in Greek patients

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2012
• First Posted: October 17, 2012
• Study Start: February 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: August 19, 2014

Record last verified: 2014-08

Locations

GR (1)