Heart Rate Variability Biofeedback: It's Role in Asthma Therapeutics

Completed · Not applicable · Has a placebo group

Conditions studied: Asthma

In brief

The goal of this research study to see whether biofeedback therapy helps treat asthma, and if so, how it works. Biofeedback is a treatment method that can teach how to bodily control. Biofeedback is widely used to help people relax. In this study however, the investigators want to learn if a specific type of biofeedback actually improves asthma in a way that might allow the reduction or elimination of other controller treatments like inhaled-corticosteroids.

Key facts

Study ID

NCT02766374

Run by

Fred Wamboldt, MD

People needed

68

Starts

2009-12-01

Expected to finish

2018-01-01

Last updated by the study team

2019-01-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Mild to moderate persistent asthma for at least the past one year
• Patients must not have taken oral or inhaled anti-inflammatory agents, including ICS and leukotriene inhibitors, for at least one month prior to study entry; and anti-IgE medications at least the past six months. Documented use of inhaled short-acting or long-acting β2-agonists during the month prior to study entry is, however, required. Xanthines, long-acting anticholinergics, and long-acting β2-agonists must be withdrawn within 72 hours upon entering the screening phase; short acting anticholinergics must be withdrawn within 48 hours before entering the screening phase. Patients will be required to abstain from these medications for the duration of study participation.
• FEV1 values must be ≥60% of predicted normal values following a 6 hour albuterol withhold, and reversibility of FEV1 of at least 12% (equal to or greater than 200 cc) following up to four puffs of albuterol must occur; or asthma physician at study site must state based on medical history, exam, and spirometry data that patient has presumptive mild-moderate persistent asthma.
• Lack of current asthma control as evidenced by ACT ≤ 19, or rescue use of B2-agonist ≥ 2/week within past 2 weeks, or waking due to asthma ≥ 1/week within past 2 weeks.
• Patients must be non-smokers for at least the past year and have less than a 15 pack-year smoking history. This will minimize the risk of co-occurring COPD
• Behavioral/linguistic competence: Ability to complete questionnaires and assessments in English
• Patients must give informed consent prior to any study procedures.

You may not qualify if…

• Diagnosis of severe persistent asthma
• 2 or more inpatient hospitalizations in the past year for asthma exacerbations;
• History of only seasonal asthma
• Patients with serious concomitant disease
• Patients who have had a respiratory tract infection within 4 weeks of screening
• Patients with a history of chronic bronchitis, COPD, or emphysema
• Patients with a history of alcohol or drug abuse, or emotional or cognitive problems requiring psychotropic medication or likely to interfere procedural and treatment adherence
• Any other clinically relevant deviation from normal in general medical history, physical examination, or laboratory parameters that would limit participation or interfere with study procedures and/or data collection;
• Presence of exclusive extra-thoracic airway dysfunction
• Women who are pregnant
• Presence of a heart rhythm or other abnormality of heart rhythm on screening EKG that could preclude ac-curate HRV assessment
• Chronically taking any medication likely to affect the autonomic or respiratory systems
• Asthma therapy and concomitant medication
• Previous participation in an investigational drug trial within 30 days prior to screening.
• Concurrent participation in any other clinical trial or observational study at any time in the study.
• Planning to move away from the area within the next 4 months

Where it is running

• National Jewish Health — Denver, Colorado, United States
• Rutgers Robert Wood Johnson Medical School — Piscataway, New Jersey, United States

Full record on ClinicalTrials.gov

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