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

Boehringer Ingelheim

Status: Completed

Conditions: Pulmonary Disease, Chronic Obstructive

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01937390

205.517

Details and patient eligibility

About

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

Enrollment: 645 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

645 participants in 1 patient group

LAMA/LABA Patients

Treatment:

Drug: Tiotropium 18µg (equivalent to 22.5µg tiotropium bromide monohydrate) HandiHaler® device Inhalation powder, hard capsule

Drug: Indacterol 150 µg

Drug: Tiotropium 2x2.5µg tiotropium (equivalent to 2x3.154µg tiotropium bromide monohydrate) Respimat® inhaler and cartridge Solution for inhalation

Drug: Indacterol 300 µg