Study of inhaler use in asthma and COPD

Cluster randomized controlled trial of the effectiveness and the cost-effectiveness of a pharmacist-led educational inhaler technique intervention on asthma and chronic obstructive pulmonary disease (COPD) patients (INspira)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN10844309

Enrollment

444

Registered

2019-05-03

Start date

2019-01-25

Completion date

Unknown

Last updated

2021-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma and chronic obstructive pulmonary disease Respiratory

Interventions

Pharmacies will be randomly allocated to either deliver an improved form of care on asthma and COPD management (group 1), or to provide the usual care they normally offer (group 2). T

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Assessed at baseline and 6 months: 1. Difference between baseline and 6-month follow-up inhaler technique score 2. COPD disease-specific HRQoL measured by COPD Assessment Test™ (CAT) 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 4. Number of Adverse Drug Events (ADEs) collected by patient questionnaire 5. Number of disease exacerbations collected by patient questionnaire 6. Health care resource utilization and costs collected by patient questionnaire Additional analysis will be conducted to explore and potentially identify factors affecting the control of the diseases.	—

Measure

Time frame

Assessed at baseline and 6 months: 1. Difference between baseline and 6-month follow-up inhaler technique score 2. COPD disease-specific HRQoL measured by COPD Assessment Test™ (CAT) 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 4. Number of Adverse Drug Events (ADEs) collected by patient questionnaire 5. Number of disease exacerbations collected by patient questionnaire 6. Health care resource utilization and costs collected by patient questionnaire Additional analysis will be conducted to explore and potentially identify factors affecting the control of the diseases.

—

Countries

Portugal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026