PEEP as Rescue Therapy for Asthmatics With Elevated BMI
| Status: | Recruiting |
|---|---|
| Conditions: | Asthma, Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 12/23/2018 |
| Start Date: | April 2016 |
| End Date: | June 2020 |
| Contact: | Anne Dixon, BM BCh |
| Email: | anne.dixon@uvmhealth.org |
| Phone: | 802 656 3525 |
Increased Lung Volume as Rescue Therapy for Asthma
The purpose of this study is to test the effect of increasing lung volume with a simple
hand-held device to both prevent, and also to relieve, airway constriction in people with
asthma and a BMI ≥ 35 kg/m2.
Twenty people with late onset non-allergic asthma and a BMI of ≥ 35 kg/m2 will be recruited.
The efficacy of elevating lung volume on both preventing and reversing bronchoconstriction
will be tested. Lung volume will be modulated by breathing out against a small level of
resistance (positive expiratory pressure).
hand-held device to both prevent, and also to relieve, airway constriction in people with
asthma and a BMI ≥ 35 kg/m2.
Twenty people with late onset non-allergic asthma and a BMI of ≥ 35 kg/m2 will be recruited.
The efficacy of elevating lung volume on both preventing and reversing bronchoconstriction
will be tested. Lung volume will be modulated by breathing out against a small level of
resistance (positive expiratory pressure).
This study will investigate whether PEEP can prevent and/or reverse bronchoconstriction in
asthmatics with a BMI > 35 kg/m2.
People with late-onset non-allergic asthma that develops in the setting of obesity do not
respond well to conventional asthma medications, likely because all treatments for asthma
have been developed to treat early-onset allergic disease in lean patients. There is a
critical need to understand the pathophysiology of airway disease in late-onset, non-allergic
obese asthmatics, in order to develop therapies to target this disease.
Airway hyperresponsiveness (AHR) is a defining characteristic in asthma. Lung function tests
in individuals with late onset asthma in the setting of obesity are suggestive of distal
airway closure rather than airway narrowing as a cause of hyperresponsiveness; these
individuals tend to have more collapsible lung peripheries than obese individuals who do not
develop asthma. If late onset asthma in obesity is related to a tendency of airways to close,
it should respond to therapies designed to keep airways open, such as Positive End-Expiratory
Pressure (PEEP).
The purpose of this study is to investigate the efficacy of PEEP on prevention and reversal
of bronchoconstriction in obese people with asthma. This will be achieved by investigating
the efficacy of PEEP therapy on preventing and reversing bronchoconstriction in response to
the inhalation of methacholine, while measuring changes in respiratory impedance using the
forced oscillation method.
Participants will initially perform a conventional methacholine challenge test.
Participants will return for 2 visits in which methacholine will be administered concurrently
with varying levels of PEEP (using PEEP to prevent bronchoconstriction) while measuring
changes in respiratory impedance using the forced oscillation method.
Participants will return for another 2 visits in which PEEP will be administered subsequent
to methacholine challenge (using PEEP to reverse bronchoconstriction) while measuring changes
in respiratory impedance using the forced oscillation method.
These studies will be completed over 5 visits.
asthmatics with a BMI > 35 kg/m2.
People with late-onset non-allergic asthma that develops in the setting of obesity do not
respond well to conventional asthma medications, likely because all treatments for asthma
have been developed to treat early-onset allergic disease in lean patients. There is a
critical need to understand the pathophysiology of airway disease in late-onset, non-allergic
obese asthmatics, in order to develop therapies to target this disease.
Airway hyperresponsiveness (AHR) is a defining characteristic in asthma. Lung function tests
in individuals with late onset asthma in the setting of obesity are suggestive of distal
airway closure rather than airway narrowing as a cause of hyperresponsiveness; these
individuals tend to have more collapsible lung peripheries than obese individuals who do not
develop asthma. If late onset asthma in obesity is related to a tendency of airways to close,
it should respond to therapies designed to keep airways open, such as Positive End-Expiratory
Pressure (PEEP).
The purpose of this study is to investigate the efficacy of PEEP on prevention and reversal
of bronchoconstriction in obese people with asthma. This will be achieved by investigating
the efficacy of PEEP therapy on preventing and reversing bronchoconstriction in response to
the inhalation of methacholine, while measuring changes in respiratory impedance using the
forced oscillation method.
Participants will initially perform a conventional methacholine challenge test.
Participants will return for 2 visits in which methacholine will be administered concurrently
with varying levels of PEEP (using PEEP to prevent bronchoconstriction) while measuring
changes in respiratory impedance using the forced oscillation method.
Participants will return for another 2 visits in which PEEP will be administered subsequent
to methacholine challenge (using PEEP to reverse bronchoconstriction) while measuring changes
in respiratory impedance using the forced oscillation method.
These studies will be completed over 5 visits.
Inclusion Criteria:
- PC20 to methacholine < 16 mg/ml
- Asthma diagnosis when ≥ 18 years of age
- Serum Immunoglobulin E < 100 IU/ml
- Ages 18 years - 60 years.
- BMI ≥ 30 kg/m2
Exclusion Criteria:
- Fever of > 38°C in last week
- Forced Expiratory Volume in 1 second < 60 % predicted
- Other significant disease that in the opinion of the investigator would interfere with
study
- Inability to perform required testing.
- Smoking within last 6 months.
- ≥ 20 pack year smoking history
- Inability to provide informed consent
- Pregnancy
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