Trial Outcomes & Findings for 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 (NCT NCT05362487)
NCT ID: NCT05362487
Last Updated: 2025-02-26
Results Overview
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).
TERMINATED
9 participants
Baseline and at Week 8.
2025-02-26
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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4
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Overall Study
Perform Visit 2 (8 Weeks)
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3
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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4
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Study was prematurely terminated as per Sponsor's decision
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4
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Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat®
n=4 Participants
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.
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Age, Continuous
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69.0 years
STANDARD_DEVIATION 7.6 • n=4 Participants
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Sex: Female, Male
Female
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2 Participants
n=4 Participants
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Sex: Female, Male
Male
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2 Participants
n=4 Participants
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Clinical COPD Questionnaire score at baseline
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3.6 score on a scale
STANDARD_DEVIATION 1.2 • n=4 Participants
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PRIMARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat®
n=3 Participants
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.
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|---|---|
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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)
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3 Participants
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SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat®
n=3 Participants
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.
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|---|---|
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Number of Participants With 0.2 Points Decrease in the CCQ Score Between Baseline and Visit 2 in Patients Independently From CCQ Baseline Score
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3 Participants
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SECONDARY outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat®
n=3 Participants
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.
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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
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1.0 Units on a scale
Standard Deviation 0.3
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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
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1.3 Units on a scale
Standard Deviation 0.0
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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
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0.8 Units on a scale
Standard Deviation 1.4
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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 outcome
Timeframe: 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.
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).
Outcome measures
| Measure |
Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat®
n=3 Participants
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.
|
|---|---|
|
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
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|
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 0.0
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|
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
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|
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 outcome
Timeframe: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
Patients Switching From Spiriva® HandiHaler® to Spiriva® Respimat®
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER