An observational study in Pulmonary Disease, Chronic Obstructive, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2018-07-27.
Sponsored by Boehringer Ingelheim · Observational
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
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 645 is above the median of 157 across 929 observational studies indexed under Lung Diseases.
Browse Lung Diseases studies →Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Caucasians
Patients clinically diagnosed of COPD with no history suggestive of asthma:
Exclusion criteria:
Drug: Tiotropium 2x2.5µg tiotropium (equivalent to 2x3.154µg tiotropium bromide monohydrate) Respimat® inhaler and cartridge Solution for inhalation · Drug: Indacterol 300 µg · Drug: Tiotropium 18µg (equivalent to 22.5µg tiotropium bromide monohydrate) HandiHaler® device Inhalation powder, hard capsule · Drug: Indacterol 150 µg
Respimat® inhaler and cartridge Solution for inhalation
inhalation powder
HandiHaler® device Inhalation powder, hard capsule
inhalation powder
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 13 months
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.
Time frame: 13 months
| Milestone | LAMA/LABA Patients |
|---|---|
| Started | 585 |
| Completed | 550 |
| Not completed | 35 |
| Withdrew: Death | 2 |
| Withdrew: Lost to follow-up | 7 |
| Withdrew: Withdrawal by subject | 5 |
| Withdrew: Fail to return | 21 |
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).
| Units on a scale | LAMA/LABA Patients |
|---|---|
| Clinical COPD Questionnaire (CCQ) Total Score Change From Baseline at Month 13 | -1.55 ± 0.05 |
Mean and standard deviation of CCQ total score is presented at month 13.
| Units on a scale | LAMA/LABA Patients |
|---|---|
| CCQ Total Score at Month 13 (Visit 4) | 2.03 ± 0.95 |
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.
| Percentage of participants | LAMA/LABA Patients |
|---|---|
| 1 Exacerbation | 1.7 |
| 2 Exacerbations | 0.7 |
| 3 Exacerbations | 0.3 |
| 4 Exacerbations | 0.5 |
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.
| Percentage of participants | LAMA/LABA Patients |
|---|---|
| 1 Exacerbation | 12.5 |
| 2 Exacerbations | 3.8 |
| 3 Exacerbations | 3.2 |
| 4 Exacerbations | 2.2 |
| 5 Exacerbations | 0.7 |
| 6 Exacerbations | 0.9 |
| 7 Exacerbations | 0.2 |
| 9 Exacerbations | 0.2 |
Percentage of subjects corresponding to each reason of non-adherence to once-daily long-acting bronchodilators in COPD patients are presented.
| Percentage of participants | LAMA/LABA Patients |
|---|---|
| Felt good and decided not to take it | 1.9 |
| Financial reasons | 1.2 |
| Felt good and forgot to take it | 0.9 |
| Did not experience any significant improvement | 0.2 |
| Ran out of medicine | 0.2 |
| Unable to tolerate side effects | 0.2 |
Collected over From enrolment in the study till end of study; up to 13 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| LAMA/LABA Patients | — | 10/585 (1.7%) | 0/585 (0%) |
| Event | LAMA/LABA Patients |
|---|---|
| DeathGeneral disorders | 5/585 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 2/585 |
| Cardiac disorderCardiac disorders | 1/585 |
| AscitesGastrointestinal disorders | 1/585 |
| Cerebrovascular accidentVascular disorders | 1/585 |
Patients who meet all of the inclusion criteria and none of the exclusion criteria (including signing the informed consent) constituted the study population.
| Age, Continuous(Years) | LAMA/LABA Patients |
|---|---|
| Mean | 57.2 ± 10.1 |
| Sex/Gender, Customized(Participants) | LAMA/LABA Patients |
|---|---|
| Female | 115 |
| Male | 465 |
| Missing | 5 |
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Boehringer Ingelheim