NCT03457103: CATCH

Capnometry-Assisted Breathing Training for COPD

Completed Phase 2 Results posted Last updated 18 August 2021

What this trial tests

Phase 2 trial testing Capnometry-Assisted Training for COPD to Slow the Breath (CATCH) in Chronic Obstructive Pulmonary Disease in 31 participants. Completed in 2 August 2019.

Timeline

16 June 2015

Primary endpoint
2 August 2019

2 August 2019

Quick facts

Lead sponsor	NYU Langone Health
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	31
Start date	16 June 2015
Primary completion	2 August 2019
Estimated completion	2 August 2019
Sites	1 location across United States

Drugs / interventions tested

• Capnometry-Assisted Training for COPD to Slow the Breath (CATCH)
• Pulmonary Rehabilitation (PR)

Conditions studied

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

Sponsor

NYU Langone Health — full company profile →

Who can join

40 and older, any sex, with Chronic Obstructive Pulmonary Disease. 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.

Number of Participants With Adherence to Home Breathing Exercises Primary · Day 1

Group	Value	95% CI
CATCH Group	10
Control Group	5

Difference in Mean 6MWT Distance Between Pre and Post Intervention Secondary · Week 0 and Week 10

The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.

Group	Value	95% CI
CATCH Group	39.37	14.13 – 64.61
Control Group	24.99	-32.53 – 82.52

Difference in Mean Dyspnea Management Questionnaire Computer Adaptive Test (DMQ-CAT) Anxiety Score Between Pre and Post Intervention Secondary · 2 weeks pre intervention and 4 weeks post intervention

The DMQ-CAT Dyspnea Anxiety is a 14 item scale; each item is scored off a 7 point likert scale for a total range of 0 to 98 where higher scores correlate with higher anxiety

Group	Value	95% CI
CATCH Group	2.43	.09 – 4.77
Control Group	-3.16	-8.89 – 2.57

Mean Difference in Heart Rate Maximum Between Pre and Post Intervention Secondary · 0 weeks and 10 weeks

Group	Value	95% CI
CATCH Group	6.2	-1.32 – 13.72
Control Group	3	-35.12 – 41.12

Difference in Mean PROMIS Fatigue Score Between Pre and Post Intervention Secondary · 0 weeks and 10 weeks

Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a questionnaire. Raw scores range from 7-35, with higher scores indicating higher levels of fatigue.

Group	Value	95% CI
CATCH Group	-4.18	-8.16 – -0.21
Control Group	5.2	-21.39 – 31.79

Mean Difference in Resting Respiratory Rate Between Pre and Post Intervention Secondary · 0 weeks and 10 weeks

Group	Value	95% CI
CATCH Group	-2.75	-7.56 – 2.05
Control Group	-4.2	-26.26 – 17.87

Difference in Mean Score on St George's Respiratory Questionnaire (SGRQ) Between Pre and Post Intervention Secondary · Week 0 and Week 10

Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.

Group	Value	95% CI
CATCH Group	-11.76	-19.68 – -3.83
Control Group	-9.96	-38.07 – 18.14

Sponsor's own description

Capnometry-Assisted Breathing Training for COPD (CATCH) is a behavioral intervention that aims to promote optimal, self-regulated, mindful breathing. A portable capnometer is used in-session to provide continuous visual feedback of Respiratory Rate (RR), End-Tidal Carbon Dioxide Tension (ETCO2), and breathing pattern. The tailored CATCH intervention will emphasize a slow, quiet, regular, nasal breathing pattern, as well as pursed lips breathing (PLB). CATCH is once weekly for 6 weeks, for a total of 6 sessions; each session is approximately 60 minutes long. The principal investigator will implement the CATCH intervention. The principal investigator will implement the CATCH intervention. Patients will use the Address Stress app on a smart phone or computer tablet as part of their home breathing exercises.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mind-Body Intervention for Dysfunctional Breathing in Chronic Obstructive Pulmonary Disease: Feasibility Study and Lessons Learned.
   Norweg AM, Wu Y, Troxel A, Whiteson JH, et al · · 2023 · cited 6× · PMID 36800224 · DOI 10.1089/jicm.2022.0552
2. Acceptability of capnography-assisted respiratory therapy: a new mind-body intervention for COPD.
   Norweg AM, Skamai A, Kwon SC, Whiteson J, et al · · 2021 · cited 5× · PMID 34938800 · DOI 10.1183/23120541.00256-2021