Compare the Effect of a Remote Monitoring System Using the EXACT Tool to Reduce Hospitalizations Due to Chronic Obstructive Pulmonary Disease (COPD) Exacerbations. EXACT = Exacerbations of Chronic Pulmonary Disease Tool.
Compare the Effect of a Remote Monitoring System Using the EXACT Tool to Reduce Hospitalizations Due to Chronic Obstructive Pulmonary Disease (COPD) Exacerbations. EXACT = Exacerbations of Chronic Pulmonary Disease Tool.
The purpose of this pilot study is to evaluate a remote patient monitoring (RPM) system using
 a daily PRO tool (EXACT = Exacerbations of Chronic Pulmonary Disease Tool), in preventing
 hospitalization from Chronic Obstructive Pulmonary Disease (COPD) exacerbations in a COPD
 population at high risk of exacerbation, compared to those managed by usual care.
This study uses two parallel groups of approximately 100 patients in each arm. After a
 screening period to confirm eligibility, patients will be randomized to either the RPM system
 group, or the usual care group. Both groups will be followed for 52 weeks until the end of
 study. There are only 4 planned study visits and patients will continue on their usual
 treatment.

 The remote patient monitoring system will issue an alert to the clinical site once the
 established threshold change has been reached. The alert notification will require the
 clinical site to contact the patient and treat the patient based on clinical judgment and
 clinical practice. Patients in the usual care arm will be managed through their normally
 nurse/physician contact.
Inclusion Criteria:

 -  Outpatients with a diagnosis of Chronic Obstructive Pulmonary Disease (COPD), GOLD
 grade 2 or higher as classified by the Global Initiative for Chronic Obstructive Lung
 Disease (GOLD) guidelines, Updated 2011, including:

 -  Current or ex-smokers with a smoking history of at least 10 pack years nt

 -  Post-bronchodilator Forced Expiratory Volume in one second (FEV1) < 80% of the
 predicted normal value within 12 months prior to screening or at screening

 -  Post-bronchodilator FEV1/FVC (Forced Vital Capacity) < 70% within 12 months prior to
 screening or at screening

 -  A documented history of at least 2 COPD exacerbations requiring treatment with
 systemic corticosteroids and/or antibiotics in the previous 12 months prior to the
 screening visit, at least one of which required hospitalization.

 Exclusion criteria:

 -  Use of investigational drugs at the time of enrollment, or within 30 days or 5
 half-lives of enrollment, whichever is longer.

 -  Patients who have a COPD exacerbation not clinically resolved within 30 days prior to
 screening.

 -  Patients with a history of asthma, indicated by (but not limited to) the onset of
 respiratory symptoms suggestive of asthma (such as cough, wheezing, shortness of
 breath) prior to age 40 years.