NCT04795323

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

Completed Phase 2 Results posted Last updated 21 December 2023

What this trial tests

Phase 2 trial testing TARA v3.1, only non-pharmacological self-management support in Pulmonary Disease, Chronic Obstructive in 5 participants. Completed in 12 March 2022.

Timeline

8 April 2021

Primary endpoint
8 March 2022

12 March 2022

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	5
Start date	8 April 2021
Primary completion	8 March 2022
Estimated completion	12 March 2022
Sites	2 locations across United States

Drugs / interventions tested

• TARA v3.1, only non-pharmacological self-management support
• TARA v3.2, both non-pharmacological and pharmacological self-management support

Conditions studied

• Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

40 and older, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in the Chronic Respiratory - Self Administered Individualized (CRQ-SAI) Dyspnea Domain Score at 12 Weeks Primary · Baseline (week 0) and Week 12.

The CRQ-SAI questionnaire first asks participants to mark important, frequent activities that made them feel out of breath during the last 2 weeks; they can select these activities from a list, and they can also add additional activities to the list. Participants are then asked to select the most important activities from the list, up to a maximum of 5 activities. Next, for each of these activities, which correspond to questions 1-5, the participants will mark their level of shortness of breath; there are 7 possible answers, ranging from 1 (being the worst: "extremely short of breath') to 7 (b

Group	Value	95% CI
Cohort 1: TARA v3.1, Only Non-pharmacological Self-management Support	2.00	0.60 – 4.00
Cohort 2: TARA v3.2, Both Non-pharmacological and Pharmacological Self-management Support	-0.20	-0.20 – -0.20

Number of Subjects With Increase From Baseline in the CRQ-SAI Dyspnea Domain Score at 12 Weeks of at Least 0.5 Primary · Baseline (week 0) and Week 12.

Number of subjects with increase from baseline in the CRQ-SAI dyspnea domain score at 12 weeks of at least 0.5, the minimal clinically important difference (MCID). The CRQ-SAI questionnaire first asks participants to mark important, frequent activities that made them feel out of breath during the last 2 weeks. Participants are then asked to select the most important activities from the list, up to a maximum of 5 activities. Next, for each of these activities, which correspond to questions 1-5, the participants will mark their level of shortness of breath; there are 7 possible answers, ranging

Group	Value	95% CI
Cohort 1: TARA v3.1, Only Non-pharmacological Self-management Support	3
Cohort 2: TARA v3.2, Both Non-pharmacological and Pharmacological Self-management Support	0

Change From Baseline in Average Number of Steps Measured by the Activity Tracker at Week 12 Secondary · Baseline (week 0) and Week 12.

Daily activity levels were measured using an activity tracker (Reemo) over 2-week periods. The average steps/day were counted over a period of up to 14 days at baseline and at Week 12. A "valid day" was defined as a day where the activity tracker records at least 8 active hours during waking hours (7 am to 10 pm local time for the participant). To calculate the average number of steps/day at baseline (also for Week 12), the data from the prior 14 days were examined. At least 4 valid days out of the 14 days were needed for analysis, but they did not have to be consecutive days. If there were fe

Group	Value	95% CI
Cohort 1: TARA v3.1, Only Non-pharmacological Self-management Support	-41.4	-564.8 – 629.5
Cohort 2: TARA v3.2, Both Non-pharmacological and Pharmacological Self-management Support	259.5	259.5 – 259.5

Change From Baseline in Average Cadence (Steps/Min) Measured by the Activity Tracker at Week 12 Secondary · Baseline (week 0) and Week 12.

Daily activity levels were measured using an activity tracker (Reemo) over 2-week periods. Cadence (steps/min) was calculated as number of steps walked per day divided by the walk time per day (in minutes), then averaged over valid days to produce the average cadence. A "valid day" was defined as a day where the activity tracker records at least 8 active hours during waking hours (7 am to 10 pm local time for the participant). To calculate the average cadence (steps/min) at baseline (also for Week 12), the data from the prior 14 days were examined. At least 4 valid days out of the 14 days were

Group	Value	95% CI
Cohort 1: TARA v3.1, Only Non-pharmacological Self-management Support	0.00	-1.63 – 1.19
Cohort 2: TARA v3.2, Both Non-pharmacological and Pharmacological Self-management Support	0.67	0.67 – 0.67

Change From Baseline in the Difficulty Domain of the Clinical Visits PROactive Physical Activity in COPD Instrument (C-PPAC) at Week 12 Secondary · Baseline (week 0) and Week 12.

C-PPAC (with focus on the difficulty domain score). The C-PPAC questionnaire has 12 questions about activities done in the last 7 days, and also records two scores (weekly steps and vector magnitude units) from an activity monitor. Three scores are generated from the C-PPAC (difficulty with physical activity, amount of physical activity and total physical activity). Only the difficulty domain score of the C-PPAC will be analyzed in this study. For each participant, the raw score for the C-PPAC difficulty domain is calculated as the sum of the numerical answers to the 10 questions 3-12. Each n

Group	Value	95% CI
Cohort 1: TARA v3.1, Only Non-pharmacological Self-management Support	14	-4 – 20
Cohort 2: TARA v3.2, Both Non-pharmacological and Pharmacological Self-management Support	0	0 – 0

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.