Overview

This trial is active, not recruiting.

Condition pulmonary disease, chronic obstructive
Treatments tiotropium bromide 2.5 µg, indacterol 300 µg, tiotropium bromide 18 µg, indacterol 150 µg
Sponsor Boehringer Ingelheim
Start date December 2012
End date September 2016
Trial size 1300 participants
Trial identifier NCT01937390, 205.517

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
tiotropium bromide 2.5 µg
Respimat® inhaler and cartridge Solution for inhalation
indacterol 300 µg
inhalation powder
tiotropium bromide 18 µg
HandiHaler® device Inhalation powder, hard capsule
indacterol 150 µg
inhalation powder

Primary Outcomes

Measure
Clinical COPD Questionnaire (CCQ) toal score change from baseline at month 13 (Visit 4)
time frame: 13 months

Secondary Outcomes

Measure
Number of COPD exacerbations leading to hospitalization, per patient
time frame: 13 months
Time to first COPD exacerbation
time frame: 13 months
Time to first COPD exacerbation leading to hospitalization
time frame: 13 months
CCQ total score at month 13 (Visit 4)
time frame: 13 months
Number of COPD exacerbations, per patient
time frame: 13 months

Eligibility Criteria

Male or female participants at least 40 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Boehringer Ingelheim.