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

Completed · Phase 2

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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.

Key facts

Study ID

NCT04795323

Run by

Boehringer Ingelheim

People needed

5

Starts

2021-04-08

Expected to finish

2022-03-12

Last updated by the study team

2023-12-21

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Research of Gastonia — Gastonia, North Carolina, United States
• Lowcountry Lung and Critical Care — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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