Breathing Training for Asthma

Targeting CO2 Levels in Breathing Training for Asthma

For the proposed randomized controlled treatment study, the investigators plan to compare the effects of this hypoventilation-based breathing training with a control intervention that will focus on breathing regularity and awareness. The two therapeutic procedures are closely matched on important variables such as duration and the nature of patient-therapist interaction, monitoring asthma related status and the medication intake, use of scientific equipment and monitoring devices to increase adherence, and initial plausibility. Asthma patients who will be evaluated before, during, directly after, and at 2 months and 6 months after training.

Study Overview

• Status: Completed
• Conditions: ASTHMA
• Intervention / Treatment: Behavioral: Capnometry Assisted Respiration Training; Behavioral: Breathing Awareness

Detailed Description

For this randomized controlled treatment study, the investigators plan to compare the effects of hypoventilation-based breathing training with a control intervention that will focus on breathing regularity and awareness. The two therapeutic procedures are closely matched on important variables such as duration and the nature of patient-therapist interaction, monitoring asthma related status and the medication intake, use of scientific equipment and monitoring devices to increase adherence, and initial plausibility. Asthma patients will be evaluated before, during, directly after, and at 1 month and 6 months after training. The primary goal of this training is to determine if a capnometry-assisted breathing training to raise end-tidal CO2 will produce more improvement in asthma control than a control training of breathing awareness. The second goal is to determine if capnometry-assisted breathing training for raising pCO2 will lead to higher pCO2 levels after training than before training on all three measures of pCO2 (the 2-hour monitoring, the standardized training sessions, and the homework assignments). The last objective is to determine if the clinical improvement in asthma outcomes for the raise-pCO2 breathing group will be greater in patients with more improvement in their pCO2.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75204
      • Baylor University Medical Center (BUMC)
    • Dallas, Texas, United States, 75275
      • Southern Methodist University (SMU)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Men or women between 18 and 65 years of age
2. Understand and read english adequately
3. A previously documented history of asthma from intermittent to severe (symptoms plus objective documentation of at least partially reversible airflow obstruction)
4. Willing to undergo a 5-session course of breathing training
5. Current asthma symptoms

Exclusion Criteria:

1. Clinically significant heart disease
2. Clinically significant cerebrovascular disease
3. Clinically significant thyroid dysfunction
4. Out-of-control diabetes
5. Use of oral corticosteroids in the last 3 months
6. Active smokers or more than 10 pack years
7. Clinically significant chronic obstructive pulmonary disease
8. Clinically significant emphysema
9. Current alcohol and substance dependence
10. Psychotic disorders and high risk for personality disorders
11. Having received previous breathing training exercises for asthma
12. Not willing to abstain from taking the morning dose of their long-term bronchodilator or leukotriene inhibitors or from using their short-acting beta-2 adrenergic agonists or anticholinergic bronchodilators for 8 hours before the pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up assessments (Medication withdrawal will be discouraged if patients should experience significant symptoms before the assessments. They will be offered to reschedule the appointment without any consequences for their enrollment in the study.)
13. Night shift workers
14. Tuberculosis
15. Pregnant, plan on becoming pregnant, or nursing during the course of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Breathing Training; Patients will receive biofeedback assisted breathing training	Behavioral: Capnometry Assisted Respiration Training; Patients learn to alter their breathing pattern by breathing abdominally, slowly, regularly, and shallowly in order to raise their PCO2 levels with the assistance of a biofeedback device.; Other Names: CART
ACTIVE_COMPARATOR: Breathing Awareness; Patients will receive biofeedback assisted breathing awareness training.	Behavioral: Breathing Awareness; Patients learn to alter their breathing pattern by breathing abdominally, slowly, regularly using a biofeedback device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pCO2 levels (as an indicator of training manipulation success)	Measured at pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up, at the beginning of each of the five weekly training sessions, patients perform self-assessments on a daily basis throughout, pre- and post-treatment 2h monitoring
diurnal PEF variability (as an indicator of asthma pathophysiology and control)	pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up
Asthma Control Test (as a self-report indicator of asthma control)	Measured at pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up. Further assessments will be made at the beginning of each of the five weekly training sessions.

Secondary Outcome Measures

Outcome Measure	Time Frame
respiration rate from capnometry and further measures of ventilation from ambulatory recordings (as further indicators of training manipulation success)	Measured at pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up, at the beginning of each of the five weekly training sessions, patients perform self-assessments on a daily basis throughout, pre- and post-treatment 2h monitoring
FeNO	Measured at pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up, at the beginning of each of the five weekly training sessions
airway hyperreactivity by methacholine	at pretreatment and optionally at 1 month follow up
spirometric lung function and respiratory resistance (as further indicators of asthma pathophysiology)	Measured at pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up, at the beginning of each of the five weekly training sessions, patients perform self-assessments on a daily basis throughout.
reported symptoms	Measured at pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up, at the beginning of each of the five weekly training sessions, patients perform self-assessments on a daily basis throughout
monitored bronchodilator use	Measured at pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up, at the beginning of each of the five weekly training sessions, patients record usage throughout treatment
reported inhaled corticosteroid use (as self-report and behavioral indicators of asthma control)	Measured at pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up, at the beginning of each of the five weekly training sessions
effects on perceived general control of asthma management, asthma self-efficacy, and impact and control of asthma triggers (as an indicator of asthma self-management)	Measured at pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up, at the beginning of each of the five weekly training sessions
physical and mental health status, stress, anxiety and depression (as indicators of general well-being)	Measured at pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up, at the beginning of each of the five weekly training sessions

Collaborators and Investigators

• Sponsor: Southern Methodist University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Baylor Health Care System
• Investigators: Principal Investigator: Alicia Meuret, PhD, SMU; Principal Investigator: Thomas Ritz, PhD, SMU; Principal Investigator: Mark Millard, MD, BUMC

Publications and helpful links

General Publications

• Ritz T, Rosenfield D, Steele AM, Millard MW, Meuret AE. Controlling asthma by training of Capnometry-Assisted Hypoventilation (CATCH) vs slow breathing: a randomized controlled trial. Chest. 2014 Nov;146(5):1237-1247. doi: 10.1378/chest.14-0665.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: September 10, 2009
• First Submitted That Met QC Criteria: September 10, 2009
• First Posted (ESTIMATE): September 11, 2009

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Asthma; Wheezing; Airway inflammation; Pulmonary; Paroxysmal; Dyspnea; Airway obstruction; Respiratory hypersensitivity
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 5R01HL89761-2; SMU IRB:KS08-051; Baylor IRB: 001-180