Re-usable Respimat® Soft MistTM Inhaler Study

Boehringer Ingelheim

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Respimat

Study type: Observational

Funder types: Industry

Identifiers

NCT04011735

1237-0097

Details and patient eligibility

About

The study is to assess patient satisfaction with the inhaler attributes of the re-usable Respimat SMI (Spiriva, Striverdi or Spiolto) in patients with COPD, including patients who are Respimat SMI-experienced and Respimat SMI-naïve. This study also aims to examine patient preference for the re-usable Respimat SMI compared to the disposable Respimat SMI in Respimat SMI-experienced patients switching from a disposable to a re-usable Respimat SMI product at study entry.

Enrollment: 262 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients fulfilling all the following inclusion criteria will be eligible for participation in the study:

• Provision of signed informed consent prior to study data collection
• Patient with COPD aged 40 years or older
• Patient prescribed (or already receiving the disposable Respimat SMI and switched to) one of the following re-usable Respimat SMI products per the standard clinical practice: Spiriva 2.5 microgram inhalation solution; (2) Striverdi 2.5 microgram inhalation solution; and (3) Spiolto 2.5 microgram / 2.5 microgram inhalation solution
• Patient unlikely to change their Respimat therapy during the 4-6 week observation period (in the opinion of the investigator)

Exclusion criteria

Patients fulfilling any of the following exclusion criteria will not be eligible for participation in the study:

• Patient using a disposable Respimat SMI product during the study period
• Patient who have had a severe COPD exacerbation requiring hospitalisation in the immediate 3 months prior to study entry
• Patient participating in a clinical trial or any other non-interventional study of a drug or device at the time of enrolment
• Visual, cognitive, motor or health impairment that, as judged by the investigator, may cause concern regarding the patient's ability to complete the questionnaires
• Patient not fluent and literate in one of the main languages of the country

Trial design

262 participants in 3 patient groups

Respimat SMI-experienced: Switching to re-usable Respimat

Description:

patients who had been on maintenance treatment with a disposable Respimat and who switched to a re-usable Respimat SMI at study entry.

Treatment:

Drug: Respimat

Respimat SMI-naïve

Description:

patients who have not previously used a Respimat SMI product and receive their first prescription at study entry

Treatment:

Drug: Respimat

Respimat SMI-experienced: Maintenance treatment

Description:

patients who have been on maintenance treatment with a Respimat SMI product and receive a refill prescription at study entry.