Study of inhaler use in asthma and COPD
Not Applicable
Completed
- Conditions
- Asthma and chronic obstructive pulmonary diseaseRespiratory
- Registration Number
- ISRCTN10844309
- Lead Sponsor
- Fundação Portuguesa do Pulmão (FPP, Portuguese Lung Foundation)
- Brief Summary
2021 results in https://doi.org/10.1016/j.rmed.2021.106507 (added 17/06/2021)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 201
Inclusion Criteria
1. Aged = 18 years old at trial enrolment
2. Self-reported asthma or COPD diagnosis
3. Chronic or first user of any of the following inhaler devices : Breezhaler; Ellipta; Spiromax; Turbohaler; pMDI; Respimat
Exclusion Criteria
1. Pregnant women
2. Individuals with any cognitive impairment
3. Motor limitations that jeopardize the performance of the technique or any other condition that not allow them to understand the study objectives or the completion of the questionnaires
4. Patients who do not give their informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of asthma, COPD and all patients (irrespective of their diagnosis asthma or COPD) who achieve 100% in the assessment of inhaler technique score at 6 months
- Secondary Outcome Measures
Name Time Method <br> Assessed at baseline and 6 months:<br> 1. Difference between baseline and 6-month follow-up inhaler technique score<br> 2. COPD disease-specific HRQoL measured by COPD Assessment Test™ (CAT)<br> 3. Disease control status measured by the Asthma Control Test™ (ACT) for Asthma patients and the Modified Medical Research Council Dyspnea Questionnaire (mMRC) for COPD patients<br> 4. Number of Adverse Drug Events (ADEs) collected by patient questionnaire<br> 5. Number of disease exacerbations collected by patient questionnaire<br> 6. Health care resource utilization and costs collected by patient questionnaire<br><br> Additional analysis will be conducted to explore and potentially identify factors affecting the control of the diseases.<br>