Breathing Training for Asthma

May 31, 2018 updated by: Alicia Meuret, Southern Methodist University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
pCO2 levels (as an indicator of training manipulation success)
Time Frame: 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
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)
Time Frame: pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up
pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up
Asthma Control Test (as a self-report indicator of asthma control)
Time Frame: 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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
respiration rate from capnometry and further measures of ventilation from ambulatory recordings (as further indicators of training manipulation success)
Time Frame: 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
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
Time Frame: 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
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
Time Frame: at pretreatment and optionally at 1 month follow up
at pretreatment and optionally at 1 month follow up
spirometric lung function and respiratory resistance (as further indicators of asthma pathophysiology)
Time Frame: 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.
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
Time Frame: 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
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
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: 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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Southern Methodist University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)
Baylor Health Care System

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alicia Meuret, PhD, SMU
  • Principal Investigator: Thomas Ritz, PhD, SMU
  • Principal Investigator: Mark Millard, MD, BUMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2013

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 10, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2009

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 4, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5R01HL89761-2
  • SMU IRB:KS08-051
  • Baylor IRB: 001-180

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