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Proof of Concept Study Assessing Technology-Assisted Respiratory Adherence Prototype Version 3 in Individuals With COPD

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Self-management support
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Individuals with COPD (IwCOPD)
  • Male or females
  • Age ≥ 40 years
  • Current or ex-smokers
  • Modified Medical Research Council Dyspnoea Scale (mMRC) score ≥ 2 (i.e. evidence of activity-related breathlessness)
  • Patients must have a prescription for either Spiriva Respimat or

Stiolto Respimat as per one of the below scenarios:

  1. Participants must have a new prescription for either Spiriva Respimat or Stiolto Respimat (this could include a patient who has never received a maintenance bronchodilator for treatment before, or a patient who was previously on an alternative maintenance bronchodilator who is being switched to Spiriva Respimat or Stiolto Respimat to help with their COPD management).

  2. Participants currently on Spiriva Respimat or Stiolto Respimat who could benefit from engagement with Technology-Assisted Respiratory Adherence prototype version 3 (after discussion with their physician).

    • Participants must be on a short-acting bronchodilator ("rescue medication")
    • Participants must be willing to use the study specific activity tracker (Reemo device) and be willing to complete all data collection requirements (within Technology-Assisted Respiratory Adherence prototype version 3) plus on-line questionnaires plus possible phone interview)
    • Fluency in written English
    • Access to a Smartphone with updated browsers installed (or willing to download up-to-date version for the study), and daily home access to internet
    • Need to have personal e-mail account that is used daily

Exclusion criteria:

  • Patients with asthma
  • Patients with confirmed, suspected or recovered SARS-CoV-2 infection or if the patient had household or other contact with an individual with confirmed SARS-CoV-2 infection.
  • Patient with a worsening COPD episode requiring medical intervention within 4 weeks of enrolment
  • Patients who have completed a pulmonary rehabilitation (PR) or self-management program in the 3 months prior to enrolment or patients who are currently in a PR program
  • Patients prescribed inhaled COPD medications other than Spiriva Respimat plus albuterol or Stiolto Respimat plus albuterol
  • Patients with any contraindications for participating in the study (after discussion with their physician).
  • Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s), or receiving other investigational treatment(s)
  • Women who are pregnant, nursing, or who plan to become pregnant while in the study
  • Any self-reported medical or neuro-cognitive condition that would limit the ability of the participant to consent

Sites / Locations

  • Clinical Research of Gastonia
  • Lowcountry Lung and Critical Care

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Non-pharmacological followed by addition of pharmacological self-management support

Arm Description

Outcomes

Primary Outcome Measures

Percentage of participants who experience a clinically significant decrease in breathlessness as measured by the Chronic Respiratory Questionnaire - Self Administered Individualized (CRQ-SAI) dyspnea domain at week 12.
Mean change in CRQ-SAI dyspnea domain from baseline to 12 weeks.
The CRQ-SAI dyspnea score ranges from 1 to 7 with higher values indicating an improvement of breathlessness.

Secondary Outcome Measures

Change from baseline in average number of steps measured by the activity tracker at week 12.
Change from baseline in average cadence (steps/min) measured by the activity tracker at week 12.
Change from baseline in the difficulty domain of the Clinical Visits PROactive Physical Activity in COPD instrument (C-PPAC) at week 12.
The C-PACC domain score ranges from 0 to 40 with a higher value representing a lesser degree of difficulty.

Full Information

First Posted
March 11, 2021
Last Updated
May 16, 2022
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT04795323
Brief Title
Proof of Concept Study Assessing Technology-Assisted Respiratory Adherence Prototype Version 3 in Individuals With COPD
Official Title
Proof of Concept (Proof of Intervention Principles) Study Assessing Effects of Technology-Assisted Respiratory Adherence Prototype Version 3 (a Digital Behaviour Change Intervention, DBCI) on Proximal Clinical Outcomes and Mediators (Psychological Mediators, Self-management Behaviours) in Individuals With COPD (IwCOPD)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 8, 2021 (Actual)
Primary Completion Date
March 8, 2022 (Actual)
Study Completion Date
March 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study's primary aim is to assess whether there is a clinically significant reduction in breathlessness in symptomatic individuals with chronic obstructive respiratory disease (IwCOPD) following engagement with Technology-Assisted Respiratory Adherence prototype 3. The study's secondary aim is to assess whether there is an associated maintenance or increase in activities of daily living to support a positive benefit of Technology-Assisted Respiratory Adherence prototype 3 on breathlessness and whether there is an improvement in the physical activity experience of the patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-pharmacological followed by addition of pharmacological self-management support
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Self-management support
Intervention Description
Self-management support
Primary Outcome Measure Information:
Title
Percentage of participants who experience a clinically significant decrease in breathlessness as measured by the Chronic Respiratory Questionnaire - Self Administered Individualized (CRQ-SAI) dyspnea domain at week 12.
Time Frame
12 weeks
Title
Mean change in CRQ-SAI dyspnea domain from baseline to 12 weeks.
Description
The CRQ-SAI dyspnea score ranges from 1 to 7 with higher values indicating an improvement of breathlessness.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in average number of steps measured by the activity tracker at week 12.
Time Frame
12 weeks
Title
Change from baseline in average cadence (steps/min) measured by the activity tracker at week 12.
Time Frame
12 weeks
Title
Change from baseline in the difficulty domain of the Clinical Visits PROactive Physical Activity in COPD instrument (C-PPAC) at week 12.
Description
The C-PACC domain score ranges from 0 to 40 with a higher value representing a lesser degree of difficulty.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Individuals with COPD (IwCOPD) Male or females Age ≥ 40 years Current or ex-smokers Modified Medical Research Council Dyspnoea Scale (mMRC) score ≥ 2 (i.e. evidence of activity-related breathlessness) Patients must have a prescription for either Spiriva Respimat or Stiolto Respimat as per one of the below scenarios: Participants must have a new prescription for either Spiriva Respimat or Stiolto Respimat (this could include a patient who has never received a maintenance bronchodilator for treatment before, or a patient who was previously on an alternative maintenance bronchodilator who is being switched to Spiriva Respimat or Stiolto Respimat to help with their COPD management). Participants currently on Spiriva Respimat or Stiolto Respimat who could benefit from engagement with Technology-Assisted Respiratory Adherence prototype version 3 (after discussion with their physician). Participants must be on a short-acting bronchodilator ("rescue medication") Participants must be willing to use the study specific activity tracker (Reemo device) and be willing to complete all data collection requirements (within Technology-Assisted Respiratory Adherence prototype version 3) plus on-line questionnaires plus possible phone interview) Fluency in written English Access to a Smartphone with updated browsers installed (or willing to download up-to-date version for the study), and daily home access to internet Need to have personal e-mail account that is used daily Exclusion criteria: Patients with asthma Patients with confirmed, suspected or recovered SARS-CoV-2 infection or if the patient had household or other contact with an individual with confirmed SARS-CoV-2 infection. Patient with a worsening COPD episode requiring medical intervention within 4 weeks of enrolment Patients who have completed a pulmonary rehabilitation (PR) or self-management program in the 3 months prior to enrolment or patients who are currently in a PR program Patients prescribed inhaled COPD medications other than Spiriva Respimat plus albuterol or Stiolto Respimat plus albuterol Patients with any contraindications for participating in the study (after discussion with their physician). Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s), or receiving other investigational treatment(s) Women who are pregnant, nursing, or who plan to become pregnant while in the study Any self-reported medical or neuro-cognitive condition that would limit the ability of the participant to consent
Facility Information:
Facility Name
Clinical Research of Gastonia
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Lowcountry Lung and Critical Care
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
IPD Sharing Time Frame
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD Sharing Access Criteria
For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
http://www.mystudywindow.com
Description
Related Info

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Proof of Concept Study Assessing Technology-Assisted Respiratory Adherence Prototype Version 3 in Individuals With COPD

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