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.

Remote Patient Monitoring in COPD Patients Clinical Trial

— PREMIERE  

Official title:

A 52-week Multi-center Randomized Trial to Evaluate Remote Patient Monitoring Using the EXACT Patient-reported Outcome Tool on Reduction of Hospitalizations From Exacerbations in Patients With Chronic Obstructive Pulmonary Disease as Compared to Those Managed by Usual Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01744028
• Other study ID #: CIDD001D2401
• Status: Completed
• Phase: Phase 1
• Start date: June 2012
• Est. completion date: January 2014

Study information

• Verified date: February 2014
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Remote Patient Monitoring in COPD Patients

Intervention

Device:
• Remote Patient Monitoring
Remote patient monitoring system including exacerbations of chronic pulmonary disease Tool - Patient Reported Outcome (EXACT PRO), Lung Monitor, and Pulse Oximeter

Other:
• Usual care
Patients in the usual care arm will continue their normally established procedures of nurse/physician contact and evaluation, as is considered standard for each individual practitioner in the study.

Locations

Country	Name	City	State
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Girona	Cataluña
Spain	Novartis Investigative Site	L'Hospitalet de Llobregat	Cataluña
Spain	Novartis Investigative Site	Lerida	Cataluña
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Majadanonda	Madrid
Spain	Novartis Investigative Site	Sant Boi de Llobregat	Cataluña
Spain	Novartis Investigative Site	Sant Cugat	Cataluña
Spain	Novartis Investigative Site	Sant Joan Despí	Cataluña
Spain	Novartis Investigative Site	Torremolinos
Sweden	Novartis Investigative Site	Gagnef
Sweden	Novartis Investigative Site	Göteborg
Sweden	Novartis Investigative Site	Kungshamn
Sweden	Novartis Investigative Site	Lund
Sweden	Novartis Investigative Site	Lund
Sweden	Novartis Investigative Site	Östersund
Sweden	Novartis Investigative Site	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of hospitalizations and emergency room visits for management of COPD exacerbation(s)	Comparison of the total number of hospitalizations and emergency room visits (combined) for management of Chronic Obstructive Pulmonary Disease (COPD) exacerbation(s) between the two arms	52 weeks
Secondary	Lenght of hospitalization	Comparison of the average length of hospital stay for management of COPD exacerbation(s) between the two arms.	52 weeks
Secondary	Time to first hospitalization	Comparison of the time to first occurrence of hospitalization for management of COPD exacerbation(s) between the two arms.	52 weeks
Secondary	Use of health care resources	Comparison of the combined health care resource utilization (hospitalizations, unscheduled, scheduled office visits, telephone call contacts) for management of COPD between the two arms.	52 weeks
Secondary	Number of medical visits	Comparison of the number of medical visits combined (hospitalizations, emergency room visits, unscheduled and scheduled office visits) for management of COPD between the two arms.	52 weeks

External Links

•   Results for CIDD001D2401 can be found on the Novartis Clinical Trial Results Website