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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01937390
• Other study ID #: 205.517
• Status: Completed
• Start date: November 6, 2011
• Est. completion date: October 22, 2016

Study information

• Verified date: October 2017
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 645
• Est. completion date: October 22, 2016
• Est. primary completion date: October 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

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
• Indacterol 300 µg
inhalation powder
• Tiotropium 18µg (equivalent to 22.5µg tiotropium bromide monohydrate) HandiHaler® device Inhalation powder, hard capsule
HandiHaler® device Inhalation powder, hard capsule
• Indacterol 150 µg
inhalation powder

Locations

Country	Name	City	State
Germany	CTMS MIGRATION CENTER representing all obvious CTMS Dummy Sites	Ingelheim am Rhein

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	Baseline and 13 Month
Primary	CCQ Total Score at Month 13 (Visit 4)	Mean and standard deviation of CCQ total score is presented at month 13.	13 months
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.	13 months
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.	13 months
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.	13 months

External Links

•   Synopsis Link