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6 months open label non-interventional observational study acc to § 4, section 23 and § 67, section 6 German Medicines Act with two parallel groups
Purpose:
Study Design:
observational
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMS group |
| ||
| control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SMS reminder | Procedure | daily SMS in the SMS group to remind of treatment with tiotropium |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to Spiriva HandiHaler Over Time | Adherence was defined as percentage of documented applications of Spiriva HandiHaler as compared to the regularly planned seven applications during the week before questioning the patients. Patients in the SMS reminder group and in the control group were asked via SMS how often they had used Spiriva HandiHaler during the last week and were requested to call the IVR system to provide their response. Baseline was defined as week 4. | Baseline, Week 8, Week 12, Week 16, Week 20 and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Adherence to Spiriva HandiHaler Over Time | Adherence was defined as percentage of documented applications of Spiriva HandiHaler as compared to the regularly planned seven applications during the week before questioning the patients. Patients in the SMS reminder group and in the control group were asked via SMS how often they had used Spiriva HandiHaler during the last week and were requested to call the IVR system to provide their response. Baseline was defined as week 4. |
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Inclusion criteria:
Exclusion criteria:
- Patients presenting with the general and specific contraindications listed in the Patient Information Leaflet and the SPC
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Patients
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Investigational Site 1 | Berlin | Germany | ||||
| Boehringer Ingelheim Investigational Site 2 |
Non-interventional controlled pilot study with two parallel groups.
Patients who participated in this study had to have access to a mobile phone since a SMS (short message service) / IVR (interactive voice response) system was used to remind to medication intake and to evaluate the adherence to Spiriva HandiHaler.
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| ID | Title | Description |
|---|---|---|
| FG000 | SMS Reminder Group | Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler. |
| FG001 | Control Group | Control group with same medication but not receiving reminder SMS. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SMS Reminder Group | Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler. |
| BG001 | Control Group | Control group with same medication but not receiving reminder SMS. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adherence to Spiriva HandiHaler Over Time | Adherence was defined as percentage of documented applications of Spiriva HandiHaler as compared to the regularly planned seven applications during the week before questioning the patients. Patients in the SMS reminder group and in the control group were asked via SMS how often they had used Spiriva HandiHaler during the last week and were requested to call the IVR system to provide their response. Baseline was defined as week 4. | Full Analysis Set (FAS) is defined as all treated patients who additionally met the study diagnosis (Chronic Obstructive Pulmonary Disease (COPD) requiring long-acting anticholinergics) and who had evaluable data in at least one effectiveness endpoint. Only subjects who responded to the SMS/ IVR system were considered in this analysis. | Posted | Mean | Standard Deviation | Percentage of applications | Baseline, Week 8, Week 12, Week 16, Week 20 and Week 24 |
|
24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SMS Reminder Group | Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| control group |
| Procedure |
no daily SMS to remind of treatment with tiotropium |
|
| Week 8, Week 12, Week 16, Week 20 and Week 24 |
| Response Rate Regarding Adherence | Adherence was dichotomised into yes and no at the end of study depending on whether the percentage of adherence was at least 80 percent or less than 80 percent, respectively. Patients who did not respond to the SMS/ IVR system to provide information about the actual number of inhalations were considered with 0 percent adherence. | 24 weeks |
| Patients Compliance With SMS System | Compliance was defined as the percentage of patients answers to the IVR system as compared to the number of SMS automatically sent to the patients by the SMS/ IVR system asking for the number of Spiriva HandiHaler applications. | 24 weeks |
| Patients Assessment of Usefulness of the SMS System | Only patients in the SMS reminder group were asked to assess the usefulness of the SMS system by the categories very helpful, helpful and not helpful. | Visit 2 (12 weeks) and visit 3 (24 weeks) |
| Physicians Assessment of Usefulness of the SMS System | Only physicians of patients in the SMS reminder group were asked to assess the usefulness of the SMS system by the categories very helpful, helpful and not helpful. | Visit 2 (12 weeks) and visit 3 (24 weeks) |
| Physicians Recommendation of the SMS System | Only physicians of patients in the SMS reminder group were asked if they would recommend the SMS system (no, yes, don't know) | Visit 2 (12 weeks) and visit 3 (24 weeks) |
| Patients Satisfaction With SMS System | Only patients in the SMS group were asked to assess their satisfaction with the SMS system by assigning German school grades 1=very good, 2=good, 3=satisfactory, 4=sufficient, 5=deficient, 6=insufficient. | Visit 2 (12 weeks) and visit 3 (24 weeks) |
| Cottbus |
| Germany |
| Boehringer Ingelheim Investigational Site 3 | Hamburg | Germany |
| Boehringer Ingelheim Investigational Site 4 | Koblenz | Germany |
| Boehringer Ingelheim Investigational Site 5 | Lübeck | Germany |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler. |
| OG001 | Control Group | Control group with same medication but not receiving reminder SMS. |
|
|
| Secondary | Change From Baseline in Adherence to Spiriva HandiHaler Over Time | Adherence was defined as percentage of documented applications of Spiriva HandiHaler as compared to the regularly planned seven applications during the week before questioning the patients. Patients in the SMS reminder group and in the control group were asked via SMS how often they had used Spiriva HandiHaler during the last week and were requested to call the IVR system to provide their response. Baseline was defined as week 4. | FAS. Only subjects who responded to the SMS/ IVR system were considered in this analysis. | Posted | Mean | Standard Deviation | Percent change | Week 8, Week 12, Week 16, Week 20 and Week 24 |
|
|
|
| Secondary | Response Rate Regarding Adherence | Adherence was dichotomised into yes and no at the end of study depending on whether the percentage of adherence was at least 80 percent or less than 80 percent, respectively. Patients who did not respond to the SMS/ IVR system to provide information about the actual number of inhalations were considered with 0 percent adherence. | FAS | Posted | Number | Percentage of participants | 24 weeks |
|
|
|
| Secondary | Patients Compliance With SMS System | Compliance was defined as the percentage of patients answers to the IVR system as compared to the number of SMS automatically sent to the patients by the SMS/ IVR system asking for the number of Spiriva HandiHaler applications. | FAS | Posted | Mean | Standard Deviation | Percentage of participants answers | 24 weeks |
|
|
|
| Secondary | Patients Assessment of Usefulness of the SMS System | Only patients in the SMS reminder group were asked to assess the usefulness of the SMS system by the categories very helpful, helpful and not helpful. | FAS for SMS reminder group only | Posted | Number | Percentage of participants | Visit 2 (12 weeks) and visit 3 (24 weeks) |
|
|
|
| Secondary | Physicians Assessment of Usefulness of the SMS System | Only physicians of patients in the SMS reminder group were asked to assess the usefulness of the SMS system by the categories very helpful, helpful and not helpful. | FAS for SMS reminder group only | Posted | Number | Percentage of participants | Visit 2 (12 weeks) and visit 3 (24 weeks) |
|
|
|
| Secondary | Physicians Recommendation of the SMS System | Only physicians of patients in the SMS reminder group were asked if they would recommend the SMS system (no, yes, don't know) | FAS for SMS reminder group only | Posted | Number | Percentage of participants | Visit 2 (12 weeks) and visit 3 (24 weeks) |
|
|
|
| Secondary | Patients Satisfaction With SMS System | Only patients in the SMS group were asked to assess their satisfaction with the SMS system by assigning German school grades 1=very good, 2=good, 3=satisfactory, 4=sufficient, 5=deficient, 6=insufficient. | FAS for SMS reminder group only | Posted | Number | Percantage of participants | Visit 2 (12 weeks) and visit 3 (24 weeks) |
|
|
|
| 2 |
| 48 |
| 0 |
| 48 |
| EG001 | Control Group | Control group with same medication but not receiving reminder SMS. | 2 | 47 | 0 | 47 |
| Syncope | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008722 | Methods |
| Week 16 (N=20, 20) |
|
| Week 20 (N=20, 21) |
|
| Week 24 (N=21, 23) |
|
| Title | Measurements |
|---|---|
|
| Missing (week 12) |
|
| Very helpful (week 24), N=45 |
|
| Helpful (week 24), N=45 |
|
| Not helpful (week 24), N=45 |
|
| Missing (week 24), N=45 |
|
| Title | Measurements |
|---|---|
|
| Missing (week 12) |
|
| Very helpful (week 24), N=45 |
|
| Helpful (week 24), N=45 |
|
| Not helpful (week 24), N=45 |
|
| Missing (week 24), N=45 |
|
| Title | Measurements |
|---|---|
|
| No (week 24), N=45 |
|
| Yes (week 24), N=45 |
|
| Don't know (week 24), N=45 |
|
| Title | Measurements |
|---|---|
|
| Sufficient (week 12) |
|
| Deficient (week 12) |
|
| Insufficient (week 12) |
|
| Very good (week 24), N=45 |
|
| Good (week 24), N=45 |
|
| Satisfactory (week 24), N=45 |
|
| Sufficient (week 24), N=45 |
|
| Deficient (week 24), N=45 |
|
| Insufficient (week 24), N=45 |
|