Overview

This trial is active, not recruiting.

Condition asthma
Treatments capnometry assisted respiration training, breathing awareness
Sponsor Ashton Jeter
Collaborator National Heart, Lung, and Blood Institute (NHLBI)
Start date July 2008
End date July 2013
Trial size 120 participants
Trial identifier NCT00975273, 5R01HL89761-2, Baylor IRB: 001-180, SMU IRB:KS08-051

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Patients will receive biofeedback assisted breathing training
capnometry assisted respiration training 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.
(Active Comparator)
Patients will receive biofeedback assisted breathing awareness training.
breathing awareness
Patients learn to alter their breathing pattern by breathing abdominally, slowly, regularly using a biofeedback device.

Primary Outcomes

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
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.

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Targeting CO2 Levels in Breathing Training for Asthma
Principal investigator Alicia Meuret, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by Southern Methodist University.