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)

Switching COPD Patients From Spiriva® HandiHaler® Maintenance Therapy to Spiriva® Respimat®: a Non-Interventional Real-world clinicAl ouTcome assEssment: NIS PIRATE

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.

Study Overview

• Status: Terminated
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Device: Spiriva® Respimat®; Device: Spiriva® HandiHaler®; Drug: Tiotropium bromide

• Study Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• Switzerland
  • Liestal, Switzerland, 4410
    • Cantonal Hosp. Baselland,Univ.Med.Dept,Liestal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients switching from Spiriva® HandiHaler® to Spiriva® Respimat®	Device: Spiriva® Respimat®; Spiriva® Respimat®; Device: Spiriva® HandiHaler®; Spiriva® HandiHaler®; Drug: Tiotropium bromide; Tiotropium bromide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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) is reported. The CCQ contains 10 questions about symptoms (items 1, 2, 5, 6 of the CCQ), functional status (CCQ-4, items 7, 8, 9 and 10 of the CCQ) and mental state (items 3, 4 of the CCQ). Each of the 10 CCQ questions is scored by the patient on a 7-point scale (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. CCQ score values can be interpreted as: acceptable (CCQ < 1); acceptable for moderate disease (1 ≤CCQ <2); instable-severe limited (2 ≤ CCQ < 3); very instable-very severe limited (CCQ ≥ 3).	Baseline and at Week 8.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With 0.2 Points Decrease in the CCQ Score Between Baseline and Visit 2 in Patients Independently From CCQ Baseline Score	Number of participants with 0.2 points decrease in the CCQ score between baseline and visit 2 in patients independently from CCQ baseline score is reported. The CCQ contains 10 questions about symptoms (items 1, 2, 5, 6 of the CCQ), functional status (CCQ-4, items 7, 8, 9 and 10 of the CCQ) and mental state (items 3, 4 of the CCQ). Each of the 10 CCQ questions is scored by the patient on a 7-point scale (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. CCQ score values can be interpreted as: acceptable (CCQ < 1); acceptable for moderate disease (1 ≤CCQ <2); instable-severe limited (2 ≤ CCQ < 3); very instable-very severe limited (CCQ ≥ 3).	Baseline and at Week 8.
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	The CCQ contains 10 questions about symptoms (items 1, 2, 5, 6 of the CCQ), functional status (CCQ-4, items 7, 8, 9 and 10 of the CCQ) and mental state (items 3, 4 of the CCQ). Each of the 10 CCQ questions is scored by the patient on a 7-point scale (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The symptom score is calculation of the sum of the 4 items (items 1, 2, 5, 6) divided by 4. The mental state score is a calculation of the sum of the 2 items (items 3, 4) divided by 2. The functional state score is a calculation of the sum of the 4 items (items 7, 8, 9, 10) divided by 4. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. CCQ score values and the CCQ subdomains score values can be interpreted as: acceptable (CCQ < 1); acceptable for moderate disease (1 ≤CCQ <2); instable-severe limited (2 ≤ CCQ < 3);very instable-very severe limited (CCQ ≥ 3).	Baseline and at Week 8.
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)	The CCQ contains 10 questions about symptoms (items 1, 2, 5, 6 of the CCQ), functional status (CCQ-4, items 7, 8, 9 and 10 of the CCQ) and mental state (items 3, 4 of the CCQ). Each of the 10 CCQ questions is scored by the patient on a 7-point scale (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The symptom score is calculation of the sum of the 4 items (items 1, 2, 5, 6) divided by 4. The mental state score is a calculation of the sum of the 2 items (items 3, 4) divided by 2. The functional state score is a calculation of the sum of the 4 items (items 7, 8, 9, 10) divided by 4. The sum of the scores divided by 10 gives the CCQ score which measures the health and functional status. CCQ score values and the CCQ subdomains score values can be interpreted as: acceptable (CCQ < 1); acceptable for moderate disease (1 ≤CCQ <2); instable-severe limited (2 ≤ CCQ < 3); very instable-very severe limited (CCQ ≥ 3).	Baseline and at Week 8.
Breathlessness of the Patients at Baseline and at Week 8	This outcome was planned to be assessed using the Modified Medical Research Council (mMRC) Questionnaire for Assessing the Severity of Breathlessness which contains one question scored by the patient on a 5-point scale between 0 and 4, with higher scores indicating severe breathlessness.	At baseline and at Week 8.
Changes in Breathlessness of the Patients From Baseline to Week 8	This outcome was planned to be assessed using the Modified Medical Research Council (mMRC) Questionnaire for Assessing the Severity of Breathlessness which contains one question scored by the patient on a 5-point scale between 0 and 4, with higher scores indicating severe breathlessness.	At baseline and at Week 8.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2022
• Primary Completion (Actual): January 18, 2023
• Study Completion (Actual): January 18, 2023

Study Registration Dates

• First Submitted: May 2, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Neurotransmitter Agents; Respiratory System Agents; Anti-Asthmatic Agents; Bronchodilator Agents; Anticonvulsants; Cholinergic Antagonists; Cholinergic Agents; Parasympatholytics; Tiotropium Bromide; Bromides
• Other Study ID Numbers: 0205-0549

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

• IPD Sharing Time Frame: After structured results have been posted, all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• IPD Sharing Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No