Errors in the Use of Turbuhaler and Spiromax Devices Patients With Asthma
1 other identifier
observational
64
1 country
4
Brief Summary
The aim of the study is to evaluate the errors that may occur during inhalation of two devices in patients with asthma, as well as to study whether it relates to the degree of control of patient symptoms and the degree of compliance of medication symptoms. Finally, we also want to study the degree of patient satisfaction with each of the inhalers studied
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2016
Shorter than P25 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 23, 2016
CompletedFirst Posted
Study publicly available on registry
December 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 10, 2017
CompletedMay 23, 2018
October 1, 2017
6 months
November 23, 2016
May 22, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The effectiveness of inhaler management.
The effectiveness of inhaler management, It will be the comparison of the means of the number of errors detected between both devices.
two months
Study Arms (2)
Patients with asthma with an inhaled steroid
Patients with a diagnosis of asthma with indication of Treatment with an inhaled steroid (CI)
Patients with asthma with an inhaled Beta agonist
Patients with a diagnosis of asthma with indication of Treatment with an inhaled Beta agonist (LABA)
Interventions
Eligibility Criteria
Patients diagnosed as asthma with indication for treatment with an inhaled steroid (IC) and long-acting beta agonist (LABA), over 18 years of age, will be consecutively included according to the criteria of the GINA 2015 (Global Strategy for Asthma Management and Prevention), who have never used dry-powder inhalers, and whose doctor has prescribed one of the inhalation systems to be studied in the normal practice of the consultation. Patients will be recruited consecutively to complete the sample size established with each type of device, in each of the participating centers.
You may qualify if:
- Diagnosis of asthma with treatment indication with CI + LABA according to GINA 2015 guide and in dry powder device.
- Over 18 years.
You may not qualify if:
- Presence of relevant respiratory disease other than asthma (including COPD).
- Refusal to participate in the study and sign informed consent or inability to To give informed consent.
- Patients who have previously been treated with inhaled dust devices dry.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hospital Universitario Puerta del Mar
Cadiz, 11009, Spain
Hospital Regional de Málaga
Málaga, Spain
Hospital Universitario Virgen Macarena
Seville, 41092, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2016
First Posted
December 6, 2016
Study Start
November 1, 2016
Primary Completion
May 1, 2017
Study Completion
October 10, 2017
Last Updated
May 23, 2018
Record last verified: 2017-10