Pulmonary Disease, Chronic Obstructive
Conditions
Brief summary
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
Interventions
DRUGTiotropium 2x2.5µg tiotropium (equivalent to 2x3.154µg tiotropium bromide monohydrate) Respimat® inhaler and cartridge Solution for inhalation
Respimat® inhaler and cartridge Solution for inhalation
DRUGIndacterol 300 µg
inhalation powder
DRUGTiotropium 18µg (equivalent to 22.5µg tiotropium bromide monohydrate) HandiHaler® device Inhalation powder, hard capsule
HandiHaler® device Inhalation powder, hard capsule
DRUGIndacterol 150 µg
inhalation powder
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female, above 40 years of age 2. Patients clinically diagnosed of COPD with no history suggestive of asthma: 1. by scores \>=5 in the COPD Population Screener, 2. by a clinical diagnosis of COPD made by pulmonologists or internists, 3. by a Forced Expiratory Volume (FEV1)/ Forced Vital Capacity (FVC6) ratio of \<=0.70 and a FEV1 \<=80% of the predicted value as assessed by copd-6 (Vitalograph, UK); 3. 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 4. Patients who are able to provide signed informed consent 5. Patients who agree to be contacted for telephone/ SMS reminders via call center
Exclusion criteria
1. Patients with contraindications to the prescribed medication 2. Patients with any disorder that would prevent the patient from being able to complete questionnaires either verbally or by self-completion 3. Pregnant or lactating women or women of childbearing potential not using an acceptable method of contraception
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical COPD Questionnaire (CCQ) Total Score Change From Baseline at Month 13 | Baseline and 13 Month | 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). |
| CCQ Total Score at Month 13 (Visit 4) | 13 months | Mean and standard deviation of CCQ total score is presented at month 13. |
| Number of COPD Exacerbations Leading to Hospitalization, Per Patient | 13 months | 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. |
| Number of COPD Exacerbations, Per Patient | 13 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reasons of Non-adherence to Once-daily Long-acting Bronchodilators in COPD Patients | 13 months | Percentage of subjects corresponding to each reason of non-adherence to once-daily long-acting bronchodilators in COPD patients are presented. |
Countries
Germany
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 585 |
| Total | 585 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 2 |
| Overall Study | Fail to return | 21 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | LAMA/LABA Patients |
|---|---|
| Age, Continuous | 57.2 Years STANDARD_DEVIATION 10.1 |
| Sex/Gender, Customized Female | 115 Participants |
| Sex/Gender, Customized Male | 465 Participants |
| Sex/Gender, Customized Missing | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 585 |
| serious Total, serious adverse events | 10 / 585 |
Outcome results
Primary
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
Population: ITT (observed cases)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LAMA/LABA Patients | CCQ Total Score at Month 13 (Visit 4) | 2.03 Units on a scale | Standard Deviation 0.95 |
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).
Time frame: Baseline and 13 Month
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LAMA/LABA Patients | Clinical COPD Questionnaire (CCQ) Total Score Change From Baseline at Month 13 | -1.55 Units on a scale | Standard Error 0.05 |
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.
Time frame: 13 months
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LAMA/LABA Patients | Number of COPD Exacerbations Leading to Hospitalization, Per Patient | 1 Exacerbation | 1.7 Percentage of participants |
| LAMA/LABA Patients | Number of COPD Exacerbations Leading to Hospitalization, Per Patient | 2 Exacerbations | 0.7 Percentage of participants |
| LAMA/LABA Patients | Number of COPD Exacerbations Leading to Hospitalization, Per Patient | 3 Exacerbations | 0.3 Percentage of participants |
| LAMA/LABA Patients | Number of COPD Exacerbations Leading to Hospitalization, Per Patient | 4 Exacerbations | 0.5 Percentage of participants |
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.
Time frame: 13 months
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LAMA/LABA Patients | Number of COPD Exacerbations, Per Patient | 5 Exacerbations | 0.7 Percentage of participants |
| LAMA/LABA Patients | Number of COPD Exacerbations, Per Patient | 1 Exacerbation | 12.5 Percentage of participants |
| LAMA/LABA Patients | Number of COPD Exacerbations, Per Patient | 2 Exacerbations | 3.8 Percentage of participants |
| LAMA/LABA Patients | Number of COPD Exacerbations, Per Patient | 3 Exacerbations | 3.2 Percentage of participants |
| LAMA/LABA Patients | Number of COPD Exacerbations, Per Patient | 4 Exacerbations | 2.2 Percentage of participants |
| LAMA/LABA Patients | Number of COPD Exacerbations, Per Patient | 6 Exacerbations | 0.9 Percentage of participants |
| LAMA/LABA Patients | Number of COPD Exacerbations, Per Patient | 7 Exacerbations | 0.2 Percentage of participants |
| LAMA/LABA Patients | Number of COPD Exacerbations, Per Patient | 9 Exacerbations | 0.2 Percentage of participants |
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.
Time frame: 13 months
Population: ITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LAMA/LABA Patients | Reasons of Non-adherence to Once-daily Long-acting Bronchodilators in COPD Patients | Did not experience any significant improvement | 0.2 Percentage of participants |
| LAMA/LABA Patients | Reasons of Non-adherence to Once-daily Long-acting Bronchodilators in COPD Patients | Felt good and decided not to take it | 1.9 Percentage of participants |
| LAMA/LABA Patients | Reasons of Non-adherence to Once-daily Long-acting Bronchodilators in COPD Patients | Financial reasons | 1.2 Percentage of participants |
| LAMA/LABA Patients | Reasons of Non-adherence to Once-daily Long-acting Bronchodilators in COPD Patients | Felt good and forgot to take it | 0.9 Percentage of participants |
| LAMA/LABA Patients | Reasons of Non-adherence to Once-daily Long-acting Bronchodilators in COPD Patients | Ran out of medicine | 0.2 Percentage of participants |
| LAMA/LABA Patients | Reasons of Non-adherence to Once-daily Long-acting Bronchodilators in COPD Patients | Unable to tolerate side effects | 0.2 Percentage of participants |