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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— NIS PIRATE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05362487
• Other study ID #: 0205-0549
• Status: Terminated
• Start date: August 5, 2022
• Est. completion date: January 18, 2023

Study information

• Verified date: February 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: January 18, 2023
• Est. primary completion date: January 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Spiriva® Respimat®
Spiriva® Respimat®
• Spiriva® HandiHaler®
Spiriva® HandiHaler®

Drug:
• Tiotropium bromide
Tiotropium bromide

Locations

Country	Name	City	State
Switzerland	Cantonal Hosp. Baselland,Univ.Med.Dept,Liestal	Liestal

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.

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