- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02983994
Errors in the Use of Turbuhaler and Spiromax Devices Patients With Asthma
May 22, 2018 updated by: Fundación Pública Andaluza Progreso y Salud
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
Study Overview
Study Type
Observational
Enrollment (Actual)
64
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cadiz, Spain, 11009
- Hospital Universitario Puerta del Mar
-
Malaga, Spain
- Hospital Regional de Málaga
-
Sevilla, Spain
- Hospital Universitario Virgen del Rocío
-
Sevilla, Spain, 41092
- Hospital Universitario Virgen Macarena
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
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.
Description
Inclusion Criteria:
- Diagnosis of asthma with treatment indication with CI + LABA according to GINA 2015 guide and in dry powder device.
- Over 18 years.
- Patient in stable phase without having had exacerbations in the 3 months previous to the Inclusion in the study
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The effectiveness of inhaler management.
Time Frame: two months
|
The effectiveness of inhaler management, It will be the comparison of the means of the number of errors detected between both devices.
|
two months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (ACTUAL)
May 1, 2017
Study Completion (ACTUAL)
October 10, 2017
Study Registration Dates
First Submitted
November 23, 2016
First Submitted That Met QC Criteria
December 2, 2016
First Posted (ESTIMATE)
December 6, 2016
Study Record Updates
Last Update Posted (ACTUAL)
May 23, 2018
Last Update Submitted That Met QC Criteria
May 22, 2018
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FPS-INH-2016-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
Johann Wolfgang Goethe University HospitalCompleted
-
Parc de Salut MarRecruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Universita di VeronaCompleted
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
-
Johann Wolfgang Goethe University HospitalCompletedExercise-induced AsthmaGermany
Clinical Trials on TURBUHALER®
-
AstraZenecaTerminated
-
AstraZenecaCompletedChronic Obstructive Pulmonary DiseaseBulgaria, Russian Federation, Romania, Ukraine, Japan
-
AstraZenecaCompleted
-
GlaxoSmithKlineCompletedAsthmaUnited Kingdom, Netherlands
-
AstraZenecaCompleted
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Cosmetique Active InternationalCompleted
-
University Hospital, BordeauxWithdrawn
-
Meir Medical CenterUnknown
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands