An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Terminated at 1 site in Switzerland. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-02-26.
Sponsored by Boehringer Ingelheim · Observational
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.
4,252 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.
This study's enrollment of 9 is below the median of 183 across 1,099 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.
Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Device: Spiriva® Respimat® · Device: Spiriva® HandiHaler® · Drug: Tiotropium bromide
Spiriva® Respimat®
Spiriva® HandiHaler®
Tiotropium bromide
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.
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.
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.
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.
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.
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.
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.
| Milestone | Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat® |
|---|---|
| Started | 4 |
| Perform visit 2 (8 weeks) | 3 |
| Completed | 0 |
| Not completed | 4 |
| Withdrew: Study was prematurely terminated as per sponsor's decision | 4 |
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).
| 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 |
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).
| 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 |
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).
| Units on a scale | Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat® |
|---|---|
| Change in CCQ score | 1.0 ± 0.3 |
| Change in CCQ symptom subdomain score | 1.3 ± 0.0 |
| Change in CCQ mental state subdomain | 0.8 ± 1.4 |
| Change in CCQ functional state subdomain | 0.8 ± 0.4 |
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).
| Units on a scale | Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat® |
|---|---|
| Change in CCQ score | 1.0 ± 0.3 |
| Change in CCQ symptom subdomain score | 1.3 ± 0.0 |
| Change in CCQ mental state subdomain | 0.8 ± 1.4 |
| Change in CCQ functional state subdomain | 0.8 ± 0.4 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over up to 8 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat® | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
Patients who fulfilled all the eligibility criteria and participated in the baseline visit of the study.
| Age, Continuous(years) | Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat® |
|---|---|
| Mean | 69.0 ± 7.6 |
| Sex: Female, Male(Participants) | Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat® |
|---|---|
| Female | 2 |
| Male | 2 |
| Race and Ethnicity Not Collected(Participants) | Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat® |
|---|
| Clinical COPD Questionnaire score at baseline(score on a scale) | Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat® |
|---|---|
| Mean | 3.6 ± 1.2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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
This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →