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

NCT ID: NCT01937390

Last Updated: 2018-07-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 645 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-06
• Study Completion Date: 2016-10-22

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

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

LAMA/LABA Patients

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

Intervention Type: DRUG

Respimat® inhaler and cartridge Solution for inhalation

Indacterol 300 µg

Intervention Type: DRUG

inhalation powder

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

Intervention Type: DRUG

HandiHaler® device Inhalation powder, hard capsule

Indacterol 150 µg

Intervention Type: DRUG

inhalation powder

Interventions

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

Intervention Type: DRUG

Indacterol 300 µg

inhalation powder

Intervention Type: DRUG

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

HandiHaler® device Inhalation powder, hard capsule

Intervention Type: DRUG

Indacterol 150 µg

inhalation powder

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

CTMS MIGRATION CENTER representing all obvious CTMS Dummy Sites

Ingelheim, , Germany

Countries

Germany

Other Identifiers

205.517

Identifier Type: -

Identifier Source: org_study_id