Breathing Training for Asthma

ASTHMA Clinical Trial

Official title:

Targeting CO2 Levels in Breathing Training for Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00975273
• Other study ID #: 5R01HL89761-2
• Secondary ID: SMU IRB:KS08-051
• Status: Completed
• Phase: N/A
• Start date: July 2008
• Est. completion date: July 2013

Study information

• Verified date: May 2018
• Source: Southern Methodist University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• ASTHMA

Intervention

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

Locations

Country	Name	City	State
United States	Baylor University Medical Center (BUMC)	Dallas	Texas
United States	Southern Methodist University (SMU)	Dallas	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Southern Methodist University	Baylor Health Care System, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	diurnal PEF variability (as an indicator of asthma pathophysiology and control)		pre-treatment, post-treatment, 1-month follow-up, and 6-month follow-up
Primary	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	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
Secondary	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
Secondary	airway hyperreactivity by methacholine		at pretreatment and optionally at 1 month follow up
Secondary	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.
Secondary	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
Secondary	monitored bronchodilator use		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
Secondary	reported inhaled corticosteroid use (as self-report and behavioral indicators of asthma control)		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
Secondary	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 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
Secondary	physical and mental health status, stress, anxiety and depression (as indicators of general well-being)		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