Trial Outcomes & Findings for Observational Study of Adherence to LABA / LAMA in Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01937390)

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

645 participants

Primary outcome timeframe

Baseline and 13 Month

Results posted on

2018-07-27

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	585
Overall Study COMPLETED	550
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Death	2
Overall Study Lost to Follow-up	7
Overall Study Withdrawal by Subject	5
Overall Study Fail to return	21

Baseline Characteristics

Observational Study of Adherence to LABA / LAMA in Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LAMA/LABA Patients n=585 Participants 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.
Age, Continuous	57.2 Years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex/Gender, Customized Female	115 Participants n=5 Participants
Sex/Gender, Customized Male	465 Participants n=5 Participants
Sex/Gender, Customized Missing	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	LAMA/LABA Patients n=585 Participants 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.
Clinical COPD Questionnaire (CCQ) Total Score Change From Baseline at Month 13	-1.55 Units on a scale Standard Error 0.05

PRIMARY outcome

Timeframe: 13 months

Population: ITT (observed cases)

Mean and standard deviation of CCQ total score is presented at month 13.

Outcome measures

Outcome measures
Measure	LAMA/LABA Patients n=478 Participants 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.
CCQ Total Score at Month 13 (Visit 4)	2.03 Units on a scale Standard Deviation 0.95

PRIMARY outcome

Timeframe: 13 months

Population: ITT

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.

Outcome measures

Outcome measures
Measure	LAMA/LABA Patients n=585 Participants 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.
Number of COPD Exacerbations Leading to Hospitalization, Per Patient 3 Exacerbations	0.3 Percentage of participants
Number of COPD Exacerbations Leading to Hospitalization, Per Patient 4 Exacerbations	0.5 Percentage of participants
Number of COPD Exacerbations Leading to Hospitalization, Per Patient 1 Exacerbation	1.7 Percentage of participants
Number of COPD Exacerbations Leading to Hospitalization, Per Patient 2 Exacerbations	0.7 Percentage of participants

PRIMARY outcome

Timeframe: 13 months

Population: ITT

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.

Outcome measures

Outcome measures
Measure	LAMA/LABA Patients n=585 Participants 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.
Number of COPD Exacerbations, Per Patient 1 Exacerbation	12.5 Percentage of participants
Number of COPD Exacerbations, Per Patient 2 Exacerbations	3.8 Percentage of participants
Number of COPD Exacerbations, Per Patient 3 Exacerbations	3.2 Percentage of participants
Number of COPD Exacerbations, Per Patient 4 Exacerbations	2.2 Percentage of participants
Number of COPD Exacerbations, Per Patient 5 Exacerbations	0.7 Percentage of participants
Number of COPD Exacerbations, Per Patient 6 Exacerbations	0.9 Percentage of participants
Number of COPD Exacerbations, Per Patient 7 Exacerbations	0.2 Percentage of participants
Number of COPD Exacerbations, Per Patient 9 Exacerbations	0.2 Percentage of participants

SECONDARY outcome

Timeframe: 13 months

Population: ITT

Percentage of subjects corresponding to each reason of non-adherence to once-daily long-acting bronchodilators in COPD patients are presented.

Outcome measures

Outcome measures
Measure	LAMA/LABA Patients n=585 Participants 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.
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
Reasons of Non-adherence to Once-daily Long-acting Bronchodilators in COPD Patients Financial reasons	1.2 Percentage of participants
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
Reasons of Non-adherence to Once-daily Long-acting Bronchodilators in COPD Patients Did not experience any significant improvement	0.2 Percentage of participants
Reasons of Non-adherence to Once-daily Long-acting Bronchodilators in COPD Patients Ran out of medicine	0.2 Percentage of participants
Reasons of Non-adherence to Once-daily Long-acting Bronchodilators in COPD Patients Unable to tolerate side effects	0.2 Percentage of participants

Adverse Events

LAMA/LABA Patients

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	LAMA/LABA Patients n=585 participants at risk 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.
General disorders Death	0.85% 5/585 • From enrolment in the study till end of study; up to 13 months. ITT Population
Cardiac disorders Cardiac disorder	0.17% 1/585 • From enrolment in the study till end of study; up to 13 months. ITT Population
Gastrointestinal disorders Ascites	0.17% 1/585 • From enrolment in the study till end of study; up to 13 months. ITT Population
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.34% 2/585 • From enrolment in the study till end of study; up to 13 months. ITT Population
Vascular disorders Cerebrovascular accident	0.17% 1/585 • From enrolment in the study till end of study; up to 13 months. ITT Population

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
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