Errors in the Use of Turbuhaler and Spiromax Devices Patients With Asthma

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

Status

Completed

Conditions

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

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.

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