Clinical trial NCT05362487: 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
Official title: Switching COPD Patients From Spiriva® HandiHaler® Maintenance Therapy to Spiriva® Respimat®: a Non-Interventional Real-world clinicAl ouTcome assEssment: NIS PIRATE
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2022-05-05
Enrollment: 9
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Chronic Obstructive Pulmonary Disease (COPD) planned to be switched according to the respective Summary of product characteristics (SmPC) and consenting to participate in the study are eligible. To avoid any selection bias, all eligible patients will be invited to participate in this study, in the order in which their eligibility is determined.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With 0.2 Points Decrease in the Clinical COPD Questionnaire (CCQ) Score Between Baseline and Visit 2 in Patients With High CCQ Baseline Score (≥ 2)
timeFrame: Baseline and at Week 8.
Secondary outcomes:
measure: Number of Participants With 0.2 Points Decrease in the CCQ Score Between Baseline and Visit 2 in Patients Independently From CCQ Baseline Score
timeFrame: Baseline and at Week 8.
measure: Changes in Clinical Control: Mean Change in the CCQ Score and in the Scores of the 3 CCQ Subdomains Symptom, Mental State, and Functional State Domain, in All Patients Independently From CCQ Baseline Score
timeFrame: Baseline and at Week 8.
measure: Changes in Clinical Control: Mean Change in the CCQ Score and in the Scores of the 3 CCQ Subdomains Symptom, Mental State, and Functional State Domain, in Patients With High CCQ Baseline Score (≥ 2)
timeFrame: Baseline and at Week 8.
measure: Breathlessness of the Patients at Baseline and at Week 8
timeFrame: At baseline and at Week 8.
measure: Changes in Breathlessness of the Patients From Baseline to Week 8
timeFrame: At baseline and at Week 8.
Other outcomes:
Locations:
city: Liestal
country: Switzerland
facility: Cantonal Hosp. Baselland,Univ.Med.Dept,Liestal
Study officials:
References: