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Breathing Training for Asthma
This study is currently recruiting participants.
Verified September 2009 by Southern Methodist University

First Received on September 10, 2009.   Last Updated on July 20, 2011   History of Changes
Sponsor: Southern Methodist University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Baylor Health Care System
Information provided by: Southern Methodist University
ClinicalTrials.gov Identifier: NCT00975273
  Purpose

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.


Condition Intervention
ASTHMA
 Behavioral: Capnometry Assisted Respiration Training
Behavioral: Breathing Awareness

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Targeting CO2 Levels in Breathing Training for Asthma

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma
U.S. FDA Resources

Further study details as provided by Southern Methodist University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • airway hyperreactivity by methacholine [ Time Frame: at pretreatment and optionally at 1 month follow up ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2008
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

Detailed Description:

For this randomized controlled treatment study, we 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00975273

Contacts
Contact: Michelle Reyes, BA 214.768.2188 mnreyes@smu.edu

Locations
United States, Texas
Southern Methodist University (SMU) Recruiting
Dallas, Texas, United States, 75275
Baylor University Medical Center (BUMC) Recruiting
Dallas, Texas, United States, 75204
Sponsors and Collaborators
Southern Methodist University
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
  More Information

No publications provided

Responsible Party: Drs. Alicia Meuret and Thomas Ritz, Stress, Anxiety, and Chronic Disease Research Center (SMU Dept. of Psychology)
ClinicalTrials.gov Identifier: NCT00975273     History of Changes
Other Study ID Numbers: 5R01HL89761-2, SMU IRB:KS08-051, Baylor IRB: 001-180
Study First Received: September 10, 2009
Last Updated: July 20, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Southern Methodist University:
Asthma
Dyspnea
Paroxysmal
Pulmonary
 Respiratory hypersensitivity
Airway inflammation
Airway obstruction
Wheezing

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012



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