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

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: 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

• Registration Number: NCT01937390
• Lead Sponsor: Boehringer Ingelheim

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-06
• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-09
• Primary Completion: 2016-10-22
• Study Completion: 2016-10-22
• Status Verified: 2017-10
• Results First Submitted: 2017-10-20
• Results First Submitted QC: 2017-10-20
• Last Update Submitted: 2017-10-20
• Results First Posted: 2018-07-27
• Last Update Posted: 2018-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 645

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LAMA/LABA Patients	Tiotropium 2x2.5µg tiotropium (equivalent to 2x3.154µg tiotropium bromide monohydrate) Respimat® inhaler and cartridge Solution for inhalation	-
LAMA/LABA Patients	Indacterol 300 µg	-
LAMA/LABA Patients	Tiotropium 18µg (equivalent to 22.5µg tiotropium bromide monohydrate) HandiHaler® device Inhalation powder, hard capsule	-
LAMA/LABA Patients	Indacterol 150 µg	-

Primary Outcome Measures

Name	Time	Method
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.
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).
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

CTMS MIGRATION CENTER representing all obvious CTMS Dummy Sites; 🇩🇪 Ingelheim am Rhein, Germany