Assessment of Health-related Quality of Life After Switching COPD Patients From a Dry Powder Inhaler to a Soft Mist Inhaler Remaining on the Same Inhalative Drug (NIS PIRATE)

Boehringer Ingelheim

Status

Terminated

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Device: Spiriva® HandiHaler®

Device: Spiriva® Respimat®

Drug: Tiotropium bromide

Study type

Observational

Funder types

Industry

Identifiers

NCT05362487

0205-0549

Details and patient eligibility

About

The objective of this non-interventional, observational study is to assess whether changing Chronic Obstructive Pulmonary Disease (COPD) patients from a dry powder inhaler (HandiHaler®) to a soft mist inhaler (Respimat®), without changing the pharmacological compound, will lead to an improvement in Clinical COPD Questionnaire (CCQ) score and in the scores of the three subdomains of CCQ score: symptoms (4 items), functional state (4 items) and mental state (2 items) during a study period of approximately 8 weeks.

Enrollment

9 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants ≥ 40 years of age at baseline visit
Patients with confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
Patients who have been on Spiriva® HandiHaler® for ≥ 6 weeks at baseline visit
Patients for whom a switch from Spiriva® HandiHaler® to Spiriva® Respimat® was planned prior to study inclusion. If additional inhalative COPD drugs (AICDs) are used: AICD treatment must have been stable for at least 6 weeks before study inclusion
Signed written informed consent form to participation

Exclusion criteria

Patients who have contraindications to Spiriva® Respimat® according to the current prescribing information label/ summary of product characteristics (SmPC)
Patients who have signs of a current, acute respiratory tract infection 2 weeks prior visit 1
Patients for whom further follow-up will not be possible at the enrolling site during the planned observational period (of approximately 8 weeks)
Patients with confirmed diagnosis of only asthma
Patients who had > 1 moderate to severe exacerbation(s) within the last 6 weeks prior to study inclusion
Patients who are pregnant or breastfeeding
Patients participating in an ongoing interventional study