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. (PREMIERE)

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

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.

Study Overview

• Status: Completed
• Conditions: Remote Patient Monitoring in COPD Patients
• Intervention / Treatment: Device: Remote Patient Monitoring; Other: Usual care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Novartis Investigative Site
  • Madrid, Spain, 28040
    • Novartis Investigative Site
  • Torremolinos, Spain, 29620
    • Novartis Investigative Site
  • Catalunya
    • Barcelona, Catalunya, Spain, 08036
      • Novartis Investigative Site
  • Cataluña
    • Barcelona, Cataluña, Spain, 08025
      • Novartis Investigative Site
    • Barcelona, Cataluña, Spain, 08035
      • Novartis Investigative Site
    • Girona, Cataluña, Spain, 17007
      • Novartis Investigative Site
    • L'Hospitalet de Llobregat, Cataluña, Spain, 08907
      • Novartis Investigative Site
    • Lerida, Cataluña, Spain, 25198
      • Novartis Investigative Site
    • Sant Boi de Llobregat, Cataluña, Spain, 08830
      • Novartis Investigative Site
    • Sant Cugat, Cataluña, Spain, 08190
      • Novartis Investigative Site
    • Sant Joan Despí, Cataluña, Spain, 08970
      • Novartis Investigative Site
  • Madrid
    • Majadanonda, Madrid, Spain, 28220
      • Novartis Investigative Site
• Sweden
  • Gagnef, Sweden, 785 21
    • Novartis Investigative Site
  • Göteborg, Sweden
    • Novartis Investigative Site
  • Kungshamn, Sweden, 456 31
    • Novartis Investigative Site
  • Lund, Sweden, SE-221 85
    • Novartis Investigative Site
  • Lund, Sweden, 222 22
    • Novartis Investigative Site
  • Stockholm, Sweden, 113 61
    • Novartis Investigative Site
  • Östersund, Sweden, 831 83
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remote patient monitoring; Remote patient monitoring system including the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) tool can use changes in daily scores over a certain threshold level to alert notification to the clinical site. The site will contact the patient in order to determine the clinical significance associated with the change in score, and to treat the patient based on clinical judgment and clinical practice.	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
Experimental: Usual care; This group of patient will continue on their usual standard care as close to real life situation as possible.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lenght of hospitalization	Comparison of the average length of hospital stay for management of COPD exacerbation(s) between the two arms.	52 weeks
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
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
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: December 4, 2012
• First Submitted That Met QC Criteria: December 5, 2012
• First Posted (Estimate): December 6, 2012

Study Record Updates

• Last Update Posted (Actual): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 8, 2020
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Keywords: COPD, remote patient monitoring, Hub, exacerbations, EXACT
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CIDD001D2401