Status:
TERMINATED
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
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 5 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 18 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05362487
Start Date
August 5 2022
End Date
January 18 2023
Last Update
February 26 2025
Active Locations (1)
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1
Cantonal Hosp. Baselland,Univ.Med.Dept,Liestal
Liestal, Switzerland, 4410