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Adherence to Medication and Its Impact on COPD Exacerbations: The AMICE Prospective Study


N/A
40 Years
N/A
Open (Enrolling)
Both
Chronic Obstructive Pulmonary Disease

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Trial Information

Adherence to Medication and Its Impact on COPD Exacerbations: The AMICE Prospective Study


Inclusion Criteria:



- Clinical diagnosis of COPD

- Age > 40 years old

- Documented spirometry within the last 12 months with a post-bronchodilator FEV1 <
80% of predicted and an FEV1 < 70% of FVC (4 puffs of salbutamol 30 minutes prior to
spirometry)

- Patients being hospitalized for an exacerbation at the University Hospitals of Leuven
at time of enrollment

- Patients currently treated with Spiriva for at least 4 weeks at the start of the data
collection (i.e. 4 weeks after hospitalization for an exacerbation)

- Oral fluency in Dutch

- Being capable to provide informed consent

Exclusion Criteria:

- A documented history of asthma or another respiratory disease

- An expected life expectancy of < 6 months

- Cognitive impairment (Mini Mental State Examination test results < 25) or presence of
other co-morbidities preventing patients from completing the self-report instruments
and/or using electronic monitoring

- Institutionalized patients, patients living in a nursing home or patients not
managing their medications independently

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

time to exacerbation

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Marc Decramer, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Universitaire Ziekenhuizen Leuven

Authority:

Belgium: Ethics Committee

Study ID:

B322201110500

NCT ID:

NCT01293890

Start Date:

March 2011

Completion Date:

Related Keywords:

  • Chronic Obstructive Pulmonary Disease
  • adherence
  • medication
  • exacerbations
  • hospital admission
  • Lung Diseases
  • Respiration Disorders
  • Pulmonary Disease, Chronic Obstructive
  • Lung Diseases, Obstructive

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