Breathing Training for Asthma

NCT00975273 | Completed DMC

• 4 other identifiers: 5R01HL89761-2SMU IRB:KS08-051Baylor IRB: 001-1805R01HL089761
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

ASTHMA

Keywords

Asthma; Dyspnea; Paroxysmal; Pulmonary; Respiratory hypersensitivity; Airway inflammation; Airway obstruction; Wheezing

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 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

Study Arms (2)

Breathing Training

EXPERIMENTAL

Patients will receive biofeedback assisted breathing training

Behavioral: Capnometry Assisted Respiration Training

Breathing Awareness

ACTIVE COMPARATOR

Patients will receive biofeedback assisted breathing awareness training.

Behavioral: Breathing Awareness

Interventions

Capnometry Assisted Respiration Training BEHAVIORAL

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.

Also known as: CART

Breathing Training

Breathing Awareness BEHAVIORAL

Patients learn to alter their breathing pattern by breathing abdominally, slowly, regularly using a biofeedback device.

Breathing Awareness

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Clinically significant heart disease
• Clinically significant cerebrovascular disease
• Clinically significant thyroid dysfunction
• Out-of-control diabetes
• Use of oral corticosteroids in the last 3 months
• Active smokers or more than 10 pack years
• Clinically significant chronic obstructive pulmonary disease
• Clinically significant emphysema
• Current alcohol and substance dependence
• Psychotic disorders and high risk for personality disorders
• Having received previous breathing training exercises for asthma
• 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.)
• Night shift workers
• Tuberculosis
• Pregnant, plan on becoming pregnant, or nursing during the course of the study

Sponsors & Collaborators

• Southern Methodist University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Baylor Health Care System: collaborator

Study Sites (2)

Baylor University Medical Center (BUMC)

Dallas, Texas, 75204, United States

Location

Southern Methodist University (SMU)

Dallas, Texas, 75275, United States

Location

Related Publications (2)

• Meuret AE, Rosenfield D, Millard MM, Ritz T. Biofeedback Training to Increase P co2 in Asthma With Elevated Anxiety: A One-Stop Treatment of Both Conditions? Psychosom Med. 2023 Jun 1;85(5):440-448. doi: 10.1097/PSY.0000000000001188. Epub 2023 Mar 23.

  PMID: 36961348 DERIVED

• 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.

  PMID: 25122497 DERIVED

MeSH Terms

Conditions

Asthma; Dyspnea; Respiratory Hypersensitivity; Airway Obstruction; Respiratory Sounds

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency

Study Officials

• Alicia Meuret, PhD

  SMU

  PRINCIPAL INVESTIGATOR

• Thomas Ritz, PhD

  SMU

  PRINCIPAL INVESTIGATOR

• Mark Millard, MD

  BUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: September 11, 2009
• Study Start: July 1, 2008
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: June 4, 2018

Record last verified: 2018-05

Locations

US (2)