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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Device: Spiriva® Respimat®
* Device: Spiriva® HandiHaler®
* Drug: Tiotropium bromide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Swiss COPD patients<br> | Device: Spiriva® Respimat®<br>* Spiriva® Respimat®<br>Device: Spiriva® HandiHaler®<br>* Spiriva® HandiHaler®<br>Drug: Tiotropium bromide<br>* Tiotropium bromide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 0.2 points decrease in the Clinical COPD Questionnaire (CCQ) score between baseline and visit 2 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 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). | At baseline and up to 8 weeks (visit 2) from baseline. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 0.2 points decrease in the CCQ score between baseline and visit 2 in 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 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). | At baseline and up to 8 weeks (visit 2) from baseline. | 
| 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 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). | At baseline and up to 8 weeks from baseline. | 
| 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 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). | At baseline and up to 8 weeks from baseline. | 
| Breathlessness of the patients | This outcome will 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 up to 8 weeks from baseline. | 
| Changes in breathlessness of the patients | This outcome will 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 up to 8 weeks from baseline. |