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

Post-Marketing Observational Study of the Impact of Adherence to Treatment With Once-Daily Administered Long-Acting Bronchodilators (LABAs / LAMAs) on Patients Health Related Quality of Life in COPD Patients

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

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Actual): 645

Contacts and Locations

Study Locations

• Germany
  • Ingelheim am Rhein, Germany, 55216
    • CTMS MIGRATION CENTER representing all obvious CTMS Dummy Sites

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Caucasians

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

LAMA/LABA Patients

Drug: Tiotropium 2x2.5µg tiotropium (equivalent to 2x3.154µg tiotropium bromide monohydrate) Respimat® inhaler and cartridge Solution for inhalation; Respimat® inhaler and cartridge Solution for inhalation; Drug: Indacterol 300 µg; inhalation powder; Drug: Tiotropium 18µg (equivalent to 22.5µg tiotropium bromide monohydrate) HandiHaler® device Inhalation powder, hard capsule; HandiHaler® device Inhalation powder, hard capsule; Drug: Indacterol 150 µg; inhalation powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Synopsis Link

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2011
• Primary Completion (Actual): October 22, 2016
• Study Completion (Actual): October 22, 2016

Study Registration Dates

• First Submitted: September 4, 2013
• First Submitted That Met QC Criteria: September 4, 2013
• First Posted (Estimate): September 9, 2013

Study Record Updates

• Last Update Posted (Actual): July 27, 2018
• Last Update Submitted That Met QC Criteria: October 20, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Anticonvulsants; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide; Bromides
• Other Study ID Numbers: 205.517