An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 15 sites in Greece. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2020-04-27.
Sponsored by Boehringer Ingelheim · Observational
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Among 236 studies in Pulmonary Disease, Chronic Obstructive by Boehringer Ingelheim — 1 open to participants now, 1 under way, 1 of them phase 3. Pulmonary Disease, Chronic Obstructive · Boehringer Ingelheim.
Among the 236 studies in Pulmonary Disease, Chronic Obstructive by Boehringer Ingelheim, this one is the 43rd largest by enrollment of the 80 observational ones that give a count, is one of 5 that started in 2018, is one of 81 observational ones, and was the 209th registered.
5,522 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →1 of the 236 studies in Pulmonary Disease, Chronic Obstructive by Boehringer Ingelheim is open now, in 3 countries. Recruiting first, the newest first:
Boehringer Ingelheim · Sites in United States, Italy, Malaysia
Ages 40+
By country, each count listing its studies:
Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 89 take healthy volunteers.
This study: 40 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
236 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,360 is above the median of 159 across 1,498 observational studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 166 across the 155 interventional studies, 1,577 across the 80 observational. Of the 232 that completed or were terminated, 124 (53%) have results posted.
This tab as a report to print or save as PDF → With an account.
Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 61 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 123 (73%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 236 studies in Pulmonary Disease, Chronic Obstructive by Boehringer Ingelheim, from their registry updates:
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Open-label observational study: including COPD patients receiving treatment with Spiolto® Respimat® for approximately 6 weeks, which is the average time between two medical consultations
1300 patients with chronic obstructive pulmonary disease (COPD) in whom combination treatment with long-acting bronchodilators is indicated in accordance with the guidelines are to be observed by approx. 100 pulmonologists in the setting of private practice. The NIS will take place in Greece and sites in urban as well as rural areas will be included. The nationwide distribution of the participating pulmonologists as well as the number of patients enrolled are intended to ensure that the data collected are representative.
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease
Drug: MaxSpiolto® Respimat® 160 Characters...
as per the approved SmPC
Also known as: INSPIOLTO, SPIOLTO, STIOLTO, VAHELVA, YANIMO
Percentage of Patients Achieving "Therapeutic Success" Defined as a ≥ 0.4 Point of Decrease in the Clinical COPD Questionnaire (CCQ) Score
Therapeutic success was defined as ≥0.4 point decrease in the Clinical COPD Questionnaire (CCQ) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was 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. A higher CCQ score is indicative of worse status. A decrease of 0.4 points is considered to be the minimal clinically important difference (MCID) for CCQ score.
Time frame: Between visit 1 (baseline visit at study start) and visit 2 (final visit after end of study, approximately 6 weeks after visit 1).
Absolute Change in Clinical COPD Questionnaire (CCQ) Score Between Visit 1 and Visit 2
Absolute change in Clinical COPD Questionaire (QQC) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale between 0 and 6. The sum of the scores divided by 10 gives the CCQ score which measured the health and functional status. A higher CCQ score is indicative of worse status.
Time frame: At visit 1 (baseline visit at study start) and at visit 2 (final visit at end of study, approximately 6 weeks after visit 1).
Absolute Change in the Functional Status Subdomain of Clinical COPD Questionnaire (CCQ-4) Score Between Visit 1 and Visit 2
Absolute change in the functional status subdomain of Clinical COPD Questionnaire (CCQ-4) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ-4 score is a subdomain of the CCQ-score. It contains 4 questions about the functional status of patients. Each questions was scored by the patient on a 7-point scale, (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The QQC-4 score was calculated by the sum of 4 questions divided by 4. A higher CCQ-4 score was indicative of worse status.
Time frame: At visit 1 (baseline visit at study start) and at visit 2 (final visit at the end of study, approximately 6 weeks after visit 1).
General Condition of Patient at Visit 1 and Visit 2
General condition of the patient, evaluated by Physician´s Global Evaluation (PGE) score at visit 1 and visit 2. The PGE score uses a eight-point ordinal scale, ranging from poor (1,2) to excellent (7,8).
Time frame: At visit 1 (baseline visit at study start) and at visit 2 (final visit at the end of study, approximately 6 weeks after visit 1).
Patients Satisfaction With Spiolto® Respimat® at Visit 2
The patients satisfaction with Respimat was assessed at end of study (visit 2) by the Patient Satisfaction and Preference Questionnaire (PASAPQ) Part 1. PASAPQ Part 1 uses a 7-point ordinal scale, ranging from very dissatisfied to very satisfied, to rate the satisfaction with inhaler attributes. The patients were requested to describe their satisfaction level answering three questions.
Time frame: At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit).
Patients Preference for Spiolto® Respimat® at Visit 2
Patients preference for Respimat® Inhaler vs. Spiriva HandiHaler (HH) was assessed using the abbreviated Patient Satisfaction and Preference Questionnaire (PASAPQ) Part 2 survey. Patients were requested to describe their preference for each inhaler device by answering 2 additional questions.
Time frame: At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit)
Patient's Willingness to Continue Treatment With Spiolto® Respimat® at Visit 2
Patients' reported willingness to continue using either of the inhalers was measured with a scale score ranking from 0 to 100. 0 indicates not willing to continue using this inhaler and 100 indicates definitely willing to continue using it.
Time frame: At visit 2 (final visit, at the end of study, approximately 6 weeks after baseline visit).
This was an open-label observational study to measure the effectiveness of 6 weeks treatment of Spiolto® Respimat® in Patients with Chronic Obstructive Pulmonary Disease (COPD). The Clinical COPD Questionnaire (CCQ)-score was used to evaluate changes in health and functional status.
| Milestone | Spiolto® Respimat® 2.5mg/2.5mg |
|---|---|
| Started | 1359 |
| Completed | 1322 |
| Not completed | 37 |
| Withdrew: Change to other medication | 1 |
| Withdrew: Refusal of continuing with trial drug | 1 |
| Withdrew: Lost to follow-up | 3 |
| Withdrew: Difficulty in inhaling the doses | 1 |
| Withdrew: Missing completion data | 31 |
Therapeutic success was defined as ≥0.4 point decrease in the Clinical COPD Questionnaire (CCQ) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was 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. A higher CCQ score is indicative of worse status. A decrease of 0.4 points is considered to be the minimal clinically important difference (MCID) for CCQ score.
| Percentage of participants | Spiolto® Respimat® 2.5mg/2.5mg |
|---|---|
| Percentage of Patients Achieving "Therapeutic Success" Defined as a ≥ 0.4 Point of Decrease in the Clinical COPD Questionnaire (CCQ) Score | 64.3 (62 to 67) |
Absolute change in Clinical COPD Questionaire (QQC) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ contained 10 questions about symptoms, functional status and mental status. Each of the 10 CCQ questions was scored by the patient on a 7-point scale between 0 and 6. The sum of the scores divided by 10 gives the CCQ score which measured the health and functional status. A higher CCQ score is indicative of worse status.
| CCQ-score | Spiolto® Respimat® 2.5mg/2.5mg |
|---|---|
| Absolute Change in Clinical COPD Questionnaire (CCQ) Score Between Visit 1 and Visit 2 | -0.63 ± 0.635 |
Absolute change in the functional status subdomain of Clinical COPD Questionnaire (CCQ-4) score between visit 1 (baseline visit at study start) and visit 2 (final visit at end of study, approximately 6 weeks after visit 1). The CCQ-4 score is a subdomain of the CCQ-score. It contains 4 questions about the functional status of patients. Each questions was scored by the patient on a 7-point scale, (ranging between 0=asymptomatic/no-limitation, to 6=symptomatic/totally limited). The QQC-4 score was calculated by the sum of 4 questions divided by 4. A higher CCQ-4 score was indicative of worse status.
| CCQ-4 score | Spiolto® Respimat® 2.5mg/2.5mg |
|---|---|
| Absolute Change in the Functional Status Subdomain of Clinical COPD Questionnaire (CCQ-4) Score Between Visit 1 and Visit 2 | -0.59 ± 0.714 |
General condition of the patient, evaluated by Physician´s Global Evaluation (PGE) score at visit 1 and visit 2. The PGE score uses a eight-point ordinal scale, ranging from poor (1,2) to excellent (7,8).
| Participants | Spiolto® Respimat® 2.5mg/2.5mg |
|---|---|
| Visit 1 — Poor (1-2) | 153 |
| Visit 1 — Satisfactory (3-4) | 496 |
| Visit 1 — Good (5-6) | 568 |
| Visit 1 — Excellent (7-8) | 115 |
| Visit 1 — Missing (Not Done) | 0 |
| Visit 2 — Poor (1-2) | 38 |
| Visit 2 — Satisfactory (3-4) | 260 |
| Visit 2 — Good (5-6) | 709 |
| Visit 2 — Excellent (7-8) | 323 |
| Visit 2 — Missing (Not Done) | 2 |
The patients satisfaction with Respimat was assessed at end of study (visit 2) by the Patient Satisfaction and Preference Questionnaire (PASAPQ) Part 1. PASAPQ Part 1 uses a 7-point ordinal scale, ranging from very dissatisfied to very satisfied, to rate the satisfaction with inhaler attributes. The patients were requested to describe their satisfaction level answering three questions.
| Participants | Spiolto® Respimat® 2.5mg/2.5mg |
|---|---|
| Satisfaction with feeling of inhaled dose — Very dissatisfied | 2 |
| Satisfaction with feeling of inhaled dose — Dissatisfied | 7 |
| Satisfaction with feeling of inhaled dose — Somewhat dissatisfied | 7 |
| Satisfaction with feeling of inhaled dose — Neither satisfied nor dissatisfied | 99 |
| Satisfaction with feeling of inhaled dose — Somewhat satisfied | 184 |
| Satisfaction with feeling of inhaled dose — Satisfied | 600 |
| Satisfaction with feeling of inhaled dose — Very satisfied | 432 |
| Satisfaction with feeling of inhaled dose — Missing | 1 |
| Satisfaction with reliability of inhaler — Very dissatisfied | 4 |
| Satisfaction with reliability of inhaler — Dissatisfied | 0 |
| Satisfaction with reliability of inhaler — Somewhat dissatisfied | 13 |
| Satisfaction with reliability of inhaler — Neither satisfied nor dissatisfied | 71 |
| Satisfaction with reliability of inhaler — Somewhat satisfied | 190 |
| Satisfaction with reliability of inhaler — Satisfied | 647 |
| Satisfaction with reliability of inhaler — Very satisfied | 406 |
| Satisfaction with reliability of inhaler — Missing | 1 |
| Satisfaction with ease of inhaling — Very dissatisfied | 3 |
| Satisfaction with ease of inhaling — Dissatisfied | 6 |
| Satisfaction with ease of inhaling — Somewhat dissatisfied | 8 |
| Satisfaction with ease of inhaling — Neither satisfied nor dissatisfied | 67 |
| Satisfaction with ease of inhaling — Somewhat satisfied | 175 |
| Satisfaction with ease of inhaling — Satisfied | 614 |
| Satisfaction with ease of inhaling — Very satisfied | 458 |
| Satisfaction with ease of inhaling — Missing | 1 |
Patients preference for Respimat® Inhaler vs. Spiriva HandiHaler (HH) was assessed using the abbreviated Patient Satisfaction and Preference Questionnaire (PASAPQ) Part 2 survey. Patients were requested to describe their preference for each inhaler device by answering 2 additional questions.
| Participants | Spiolto® Respimat® 2.5mg/2.5mg |
|---|---|
| Preference for Spiriva HH | 17 |
| Preference for Spiolto Respimat | 217 |
| No preference | 20 |
Patients' reported willingness to continue using either of the inhalers was measured with a scale score ranking from 0 to 100. 0 indicates not willing to continue using this inhaler and 100 indicates definitely willing to continue using it.
| Scores on scale | Spiolto® Respimat® 2.5mg/2.5mg |
|---|---|
| Scoring of Spiriva HH | 32.3 ± 27.06 |
| Scoring of Spiolto® Respimat® | 79.8 ± 21.19 |
Collected over From study start until end of study, up to 6 weeks.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Spiolto® Respimat® 2.5mg/2.5mg | 0/1,359 (0%) | 1/1,359 (0.1%) | 0/1,359 (0%) |
| Event | Spiolto® Respimat® 2.5mg/2.5mg |
|---|---|
| Chronic Obstructive Pulmonary DiseaseRespiratory, thoracic and mediastinal disorders | 1/1359 |
Treated Set (TS): Treated set included all screened patients with the informed consent, date of registration and at least one documented administration of Spiolto® Respimat®.
| Age, Continuous(Years) | Spiolto® Respimat® 2.5mg/2.5mg |
|---|---|
| Mean | 68.1 ± 10.17 |
| Sex: Female, Male(Participants) | Spiolto® Respimat® 2.5mg/2.5mg |
|---|---|
| Female | 437 |
| Male | 922 |
| Race and Ethnicity Not Collected(Participants) | Spiolto® Respimat® 2.5mg/2.5mg |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2018 to primary completion in Nov 2018, 7 months.
Results were first posted in Apr 2020, 1 year 5 months after primary completion.
Of 120 industry-sponsored observational studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 37. This study's 7 months is below that.
Counting every sponsor, half of 587 studies reached it within 26 months; a quarter within 14 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →