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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01744028
First received: December 4, 2012
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Remote Patient Monitoring in COPD Patients
Device: Remote Patient Monitoring
Other: Usual care
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • The number of hospitalizations and emergency room visits for management of COPD exacerbation(s) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Lenght of hospitalization [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Comparison of the average length of hospital stay for management of COPD exacerbation(s) between the two arms.

  • Time to first hospitalization [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Comparison of the time to first occurrence of hospitalization for management of COPD exacerbation(s) between the two arms.

  • Use of health care resources [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    Comparison of the combined health care resource utilization (hospitalizations, unscheduled, scheduled office visits, telephone call contacts) for management of COPD between the two arms.

  • Number of medical visits [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 118
Study Start Date: June 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744028

Locations
Spain
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08036
Novartis Investigative Site
Barcelona, Cataluña, Spain, 08035
Novartis Investigative Site
Barcelona, Cataluña, Spain, 08025
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
Majadanonda, Madrid, Spain, 28220
Novartis Investigative Site
Madrid, Spain, 28034
Novartis Investigative Site
Madrid, Spain, 28040
Novartis Investigative Site
Torremolinos, Spain, 29620
Sweden
Novartis Investigative Site
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
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01744028     History of Changes
Other Study ID Numbers: CIDD001D2401
Study First Received: December 4, 2012
Last Updated: February 6, 2014
Health Authority: Spain: Ministry of Health
Sweden: Medical Products Agency

Keywords provided by Novartis:
COPD, remote patient monitoring, Hub, exacerbations, EXACT

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014