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The objective of the study is to observe the effect of adherence to once-daily administered long-acting bronchodilators (long-acting ß2-agonists [LABAs] / long-acting muscarinic antagonists [LAMAs]) on patients health related quality of life (HR-QoL) and to assess the relation between symptoms improvement and adherence to Chronic Obstructive Pulmonary Disease (COPD) maintenance therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LAMA/LABA Patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tiotropium 2x2.5µg tiotropium (equivalent to 2x3.154µg tiotropium bromide monohydrate) Respimat® inhaler and cartridge Solution for inhalation | Drug | Respimat® inhaler and cartridge Solution for inhalation |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical COPD Questionnaire (CCQ) Total Score Change From Baseline at Month 13 | The Clinical COPD (Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) is a standardized, validated and reliable questionnaire (in local language) to assess the impact of treatment on health status in COPD patients. CCQ total score is calculated as the arithmetic average of 10 individual scores on a 7-point scale. CCQ total score varies from 0 (very good control) to 6 (extremely poor control). Mean change in CCQ total score from baseline at month 13 is presented along with its standard error. Change in CCQ total score is calculated for each subject as: CCQ total score at month 13 - CCQ total score at baseline. Baseline is defined as the first assessment after enrolment (at Month 1). | Baseline and 13 Month |
| CCQ Total Score at Month 13 (Visit 4) | Mean and standard deviation of CCQ total score is presented at month 13. | 13 months |
| Number of COPD Exacerbations Leading to Hospitalization, Per Patient | Percentage of subjects hospitalized due to COPD exacerbations exactly "n" number of times during the study period is presented. Here, "n" represents the number of times each subject is hospitalized due to COPD exacerbations. | 13 months |
| Number of COPD Exacerbations, Per Patient | Percentage of subjects experienced COPD exacerbations exactly "n" number of times during the study period is presented. Here, "n" represents the number of times each subject experienced COPD exacerbations. | 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reasons of Non-adherence to Once-daily Long-acting Bronchodilators in COPD Patients | Percentage of subjects corresponding to each reason of non-adherence to once-daily long-acting bronchodilators in COPD patients are presented. | 13 months |
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Inclusion criteria:
Male or female, above 40 years of age
Patients clinically diagnosed of COPD with no history suggestive of asthma:
Maintenance treatment-naïve COPD patients who have been prescribed once daily long-acting bronchodilators (LABAs / LAMAs) for the first time at enrolment into the study
Patients who are able to provide signed informed consent
Patients who agree to be contacted for telephone/ SMS reminders via call center
Exclusion criteria:
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Caucasians
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CTMS MIGRATION CENTER representing all obvious CTMS Dummy Sites | Ingelheim | 55216 | Germany |
A total of 645 subjects were screened in this study, out of which 585 satisfied the selection criteria and were finally entered in to the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | LAMA/LABA Patients | Patients taking once daily oral inhalation of Long-acting bronchodilators (long-acting β2-agonists [LABAs]/ long-acting muscarinic antagonists [LAMAs]) during the study period of 52 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Indacterol 300 µg | Drug | inhalation powder |
|
| Tiotropium 18µg (equivalent to 22.5µg tiotropium bromide monohydrate) HandiHaler® device Inhalation powder, hard capsule | Drug | HandiHaler® device Inhalation powder, hard capsule |
|
| Indacterol 150 µg | Drug | inhalation powder |
|
| COMPLETED |
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| NOT COMPLETED |
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Patients who meet all of the inclusion criteria and none of the exclusion criteria (including signing the informed consent) constituted the study population.
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| ID | Title | Description |
|---|---|---|
| BG000 | LAMA/LABA Patients | Patients taking once daily oral inhalation of Long-acting bronchodilators (long-acting β2-agonists [LABAs]/ long-acting muscarinic antagonists [LAMAs]) during the study period of 52 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex/Gender, Customized | Number | Participants |
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| 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 | Clinical COPD Questionnaire (CCQ) Total Score Change From Baseline at Month 13 | The Clinical COPD (Chronic Obstructive Pulmonary Disease) Questionnaire (CCQ) is a standardized, validated and reliable questionnaire (in local language) to assess the impact of treatment on health status in COPD patients. CCQ total score is calculated as the arithmetic average of 10 individual scores on a 7-point scale. CCQ total score varies from 0 (very good control) to 6 (extremely poor control). Mean change in CCQ total score from baseline at month 13 is presented along with its standard error. Change in CCQ total score is calculated for each subject as: CCQ total score at month 13 - CCQ total score at baseline. Baseline is defined as the first assessment after enrolment (at Month 1). | Intent-to-treat (ITT): This population set included all subjects who signed informed consent form (ICF), satisfied all inclusion and exclusion criteria and have taken at least one dose of study drug. | Posted | Mean | Standard Error | Units on a scale | Baseline and 13 Month |
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| Primary | CCQ Total Score at Month 13 (Visit 4) | Mean and standard deviation of CCQ total score is presented at month 13. | ITT (observed cases) | Posted | Mean | Standard Deviation | Units on a scale | 13 months |
|
| ||||||||||||||||||||||||||
| Primary | Number of COPD Exacerbations Leading to Hospitalization, Per Patient | Percentage of subjects hospitalized due to COPD exacerbations exactly "n" number of times during the study period is presented. Here, "n" represents the number of times each subject is hospitalized due to COPD exacerbations. | ITT | Posted | Number | Percentage of participants | 13 months |
|
| |||||||||||||||||||||||||||
| Primary | Number of COPD Exacerbations, Per Patient | Percentage of subjects experienced COPD exacerbations exactly "n" number of times during the study period is presented. Here, "n" represents the number of times each subject experienced COPD exacerbations. | ITT | Posted | Number | Percentage of participants | 13 months |
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| Secondary | Reasons of Non-adherence to Once-daily Long-acting Bronchodilators in COPD Patients | Percentage of subjects corresponding to each reason of non-adherence to once-daily long-acting bronchodilators in COPD patients are presented. | ITT | Posted | Number | Percentage of participants | 13 months |
|
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From enrolment in the study till end of study; up to 13 months.
ITT Population
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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 | LAMA/LABA Patients | Patients taking once daily oral inhalation of Long-acting bronchodilators (long-acting β2-agonists [LABAs]/ long-acting muscarinic antagonists [LAMAs]) during the study period of 52 weeks. | 10 | 585 | 0 | 585 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA Version:19.1 | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA Version:19.1 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA Version:19.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version:19.1 | Systematic Assessment |
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| Cerebrovascular accident | Vascular disorders | MedDRA Version:19.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001239 | Inhalation |
| D000069447 | Tiotropium Bromide |
| D006244 | Hardness |
| ID | Term |
|---|---|
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
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