ASTHMANCT00975273
Breathing Training for Asthma
A study testing Capnometry Assisted Respiration Training and Breathing Awareness in people with ASTHMA, run by Southern Methodist University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ASTHMA
- What is being tested?
- Capnometry Assisted Respiration Training and Breathing Awareness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2008to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baylor University Medical Center (BUMC)
Dallas, Texas, 75204
Southern Methodist University (SMU)
Dallas, Texas, 75275
About this study
Official title: 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.
Read the 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.
- Conditions
- ASTHMA
- Being tested
- Capnometry Assisted Respiration Training, Breathing Awareness
- Keywords
- Asthma, Dyspnea, Paroxysmal, Pulmonary, Respiratory hypersensitivity, Airway inflammation, Airway obstruction, Wheezing
- Medical subject headings
- Asthma, Dyspnea, Respiratory Hypersensitivity, Airway Obstruction, Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capnometry Assisted Respiration TrainingBehavioural
Also called CART
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.
Breathing AwarenessBehavioural
Patients learn to alter their breathing pattern by breathing abdominally, slowly, regularly using a biofeedback device.
| Study group | Role | What they receive |
|---|---|---|
| Breathing Training | Experimental | Patients will receive biofeedback assisted breathing training Receives: Behavioral: Capnometry Assisted Respiration Training |
| Breathing Awareness | Active comparator | Patients will receive biofeedback assisted breathing awareness training. Receives: Behavioral: Breathing Awareness |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCO2 levels (as an indicator of training manipulation success)
Measured: 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)
Measured: 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: 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: 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: 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
Measured: at pretreatment and optionally at 1 month follow up
spirometric lung function and respiratory resistance (as further indicators of asthma pathophysiology)
Measured: 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: 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: 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: 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: 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: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startJul 2008
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ASTHMAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Methodist University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Baylor Health Care System
- Responsible party
- Principal investigator, Alicia Meuret, Southern Methodist University
- Investigators
- Alicia Meuret, PhD, Principal investigator, SMUThomas Ritz, PhD, Principal investigator, SMUMark Millard, MD, Principal investigator, BUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975273
- Sponsor's protocol ID
- 5R01HL89761-2
- Other IDs
- SMU IRB:KS08-051, Baylor IRB: 001-180, 5R01HL089761
- Status last verified
- May 2018
- First submitted
- 10 Sep 2009
- Last updated
- 4 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 36961348Ritz 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.
PubMed 25122497
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting CO2 Levels in Breathing Training for Asthma
- ClinicalTrials.gov ID
- NCT00975273
- Acronym / sponsor ID
- 5R01HL89761-2
- Conditions
- ASTHMA
- Keywords
- Asthma, Dyspnea, Paroxysmal, Pulmonary, Respiratory hypersensitivity, Airway inflammation, Airway obstruction, Wheezing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Southern Methodist UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Baylor Health Care System
- Study start
- Jul 2008
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathing Training | Experimental | Behavioral: Capnometry Assisted Respiration TrainingPatients will receive biofeedback assisted breathing training |
| Breathing Awareness | Active comparator | Behavioral: Breathing AwarenessPatients will receive biofeedback assisted breathing awareness training. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capnometry Assisted Respiration TrainingAlso: CARTPatients 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. | Behavioural | Breathing Training |
| Breathing AwarenessPatients learn to alter their breathing pattern by breathing abdominally, slowly, regularly using a biofeedback device. | Behavioural | Breathing Awareness |
Primary outcome
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
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
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.
9 secondary outcomes
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
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
airway hyperreactivity by methacholine
Time frame: 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.
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Derived from this study: PubMed 36961348Meuret 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.
- Derived from this study: PubMed 25122497Ritz 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.
Related trials for ASTHMA
Active, not recruitingPhase 3
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma
Asthma
Not yet recruitingPhase 1
Study of HXN-1013 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Health Adults, Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 1
A Phase 1 Trial of AMG 691 in Healthy Chinese and Japanese Volunteers
Healthy Participants
RecruitingPhase 1/2
A Study of HB0056 in Adult Participants With Moderate to Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia Meuret, PhD principal investigator
SMU
Thomas Ritz, PhD principal investigator
SMU
Mark Millard, MD principal investigator
BUMC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capnometry Assisted Respiration Training and Breathing Awareness in people with ASTHMA, run by Southern Methodist University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00975273, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2018.