Pulmonary Disease, Chronic Obstructive
Conditions
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.
Interventions
DEVICESpiriva® Respimat®
Spiriva® Respimat®
DEVICESpiriva® HandiHaler®
Spiriva® HandiHaler®
DRUGTiotropium bromide
Tiotropium bromide
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Baseline and at Week 8. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 0.2 Points Decrease in the CCQ Score Between Baseline and Visit 2 in Patients Independently From CCQ Baseline Score | Baseline and at Week 8. | 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). |
| 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 | Baseline and at Week 8. | 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). |
| 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) | Baseline and at Week 8. | 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). |
| Breathlessness of the Patients at Baseline and at Week 8 | 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. |
| Changes in Breathlessness of the Patients From Baseline to Week 8 | 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. |
Countries
Switzerland
Participant flow
Recruitment details
This was a national, multicenter, non-interventional, observational, cohort study based on newly collected data with an observational period of at least 8 weeks until switch or discontinuation of Spiriva® Respimat® treatment or up to 52 weeks after baseline visit whatever occurs first.
Pre-assignment details
All subjects were screened for eligibility prior to participation in the study. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated. Out of 9 patients who were screened only 4 participated in the study.
Participants by arm
| Arm | Count |
|---|---|
| Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat® This arm includes patients with confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD) who were switched from Spiriva® HandiHaler® which contains 18 microgram tiotropium powder for inhalation to Spiriva® Respimat® which contains 2.5 microgram tiotropium per puff inhalation solution. The recommended daily dose of Spiriva® Respimat® for adults is 5 micrograms of tiotropium, equivalent to inhaling 2 puffs from the Respimat® inhaler once daily at the same time of day. | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Study was prematurely terminated as per Sponsor's decision | 4 |
Baseline characteristics
| Characteristic | Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat® | — |
|---|---|---|
| Age, Continuous | 69.0 years STANDARD_DEVIATION 7.6 | — |
| Clinical COPD Questionnaire score at baseline | 3.6 score on a scale STANDARD_DEVIATION 1.2 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
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).
Time frame: Baseline and at Week 8.
Population: Patients who fulfilled all the eligibility criteria, participated at the baseline visit and had post-baseline data for the primary outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat® | 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) | 3 Participants |
Secondary
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.
Time frame: At baseline and at Week 8.
Population: Data for this Outcome Measure were not collected from any of the patients who attended the baseline study visit or the study visit at Week 8.
Secondary
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.
Time frame: At baseline and at Week 8.
Population: Data for this Outcome Measure were not collected from any of the patients who attended the baseline study visit or the study visit at Week 8.
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 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).
Time frame: Baseline and at Week 8.
Population: Patients who fulfilled all the eligibility criteria, participated at the baseline visit and had post-baseline data for the primary outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat® | 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 | Change in CCQ score | 1.0 Units on a scale | Standard Deviation 0.3 |
| Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat® | 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 | Change in CCQ symptom subdomain score | 1.3 Units on a scale | Standard Deviation 0 |
| Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat® | 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 | Change in CCQ mental state subdomain | 0.8 Units on a scale | Standard Deviation 1.4 |
| Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat® | 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 | Change in CCQ functional state subdomain | 0.8 Units on a scale | Standard Deviation 0.4 |
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 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).
Time frame: Baseline and at Week 8.
Population: Patients who fulfilled all the eligibility criteria, participated at the baseline visit and had post-baseline data for the primary outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat® | 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) | Change in CCQ score | 1.0 Units on a scale | Standard Deviation 0.3 |
| Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat® | 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) | Change in CCQ symptom subdomain score | 1.3 Units on a scale | Standard Deviation 0 |
| Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat® | 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) | Change in CCQ mental state subdomain | 0.8 Units on a scale | Standard Deviation 1.4 |
| Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat® | 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) | Change in CCQ functional state subdomain | 0.8 Units on a scale | Standard Deviation 0.4 |
Secondary
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).
Time frame: Baseline and at Week 8.
Population: Patients who fulfilled all the eligibility criteria, participated at the baseline visit and had post-baseline data for the primary outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat® | Number of Participants With 0.2 Points Decrease in the CCQ Score Between Baseline and Visit 2 in Patients Independently From CCQ Baseline Score | 3 Participants |