Phase 2
Completed N=5
Proof of Concept Study Assessing Technology-Assisted Respiratory Adherence Prototype Version 3 in Individuals With COPD
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT04795323 ↗
Enrolled (actual)
5
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcomePrimary: Change From Baseline in the Chronic Respiratory - Self Administered Individualized (CRQ-SAI) Dyspnea Domain Score at 12 Weeks — 2.00; -0.20 Score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Chronic Respiratory - Self Administered Individualized (CRQ-SAI) Dyspnea Domain Score at 12 Weeks |
2.00; -0.20 | — |
| PRIMARY Number of Subjects With Increase From Baseline in the CRQ-SAI Dyspnea Domain Score at 12 Weeks of at Least 0.5 |
3; 0 | — |
| SECONDARY Change From Baseline in Average Number of Steps Measured by the Activity Tracker at Week 12 |
-41.4; 259.5 | — |
| SECONDARY Change From Baseline in Average Cadence (Steps/Min) Measured by the Activity Tracker at Week 12 |
0.00; 0.67 | — |
| SECONDARY Change From Baseline in the Difficulty Domain of the Clinical Visits PROactive Physical Activity in COPD Instrument (C-PPAC) at Week 12 |
14; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT04795323). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.