An open-label, low interventional clinical study investigating error rates (critical and overall) prior to any retraining in correct use of the ELLIPTA dry powder inhaler (DPI) compared to other DPIs including; DISKUS, Turbuhaler, HandiHaler and Breezhaler as a monotherapy or in combination, in adult patients with Chronic Obstructive Pulmonary Disease (COPD) (study 204981)

An open-label, low interventional clinical study investigating error rates (critical and overall) prior to any retraining in correct use of the ELLIPTA dry powder inhaler (DPI) compared to other DPIs including; DISKUS, Turbuhaler, HandiHaler and Breezhaler as a monotherapy or in combination, in adult patients with Chronic Obstructive Pulmonary Disease (COPD) (study 204981) - 204981

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46129

Enrollment

360

Registered

2017-10-05

Start date

2017-06-29

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

chronic obstructive airways disease (COPD)

Interventions

Demonstration of inhaler use. Corrective actions. Completion of CAT questionnaire.

comparison

COPD

dry powder inhaler

ELLIPTA

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: * *40 years of age. * COPD. * Currently receiving maintenance therapy with one of the treatments listed in table 1 of the protocol (page 17-18).

Exclusion criteria

Exclusion criteria: * Asthma. * Participants who have been trained during participation in any device study in the 6 months prior to entry into this study * Drug/alcohol abuse.

Design outcomes

Primary

Measure	Time frame
The percentage of participants making at least one critical error at V1 for each DPI tested.	—

Secondary

Measure	Time frame
The percentage of participants making at least one critical error at V2 for each DPI tested. The percentage of participants making at least one critical or overall error at V2 for each DPI tested.	—

Countries

Netherlands, United Kingdom

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)