Persistent Asthma
Conditions
Keywords
Lung Flute
Brief summary
We hypothesized that the ability of the Lung Flute to enhance mucus clearance from the lower airways could be used to improve asthma control, if the device is used on a chronic basis. The primary end point of the study is the comparison of Asthma Control Test (ACT) - a validated questionnaire for asthma control and exhaled NO before, during and after using the lung flute. Several secondary end points were assessed for efficacy and safety, including health status, spirometric lung function, stepping down controller therapy and daily albuterol use.
Detailed description
This is a 3 month open label study. We plan to enroll 48 subjects with asthma at the Buffalo General Medical Center Allergy Clinic or the office of Dr. James Cumella. Inclusion criteria includes: at least 12 years of age, diagnosis of asthma and no current or previous history of smoking. Exclusion criteria includes: exacerbation of asthma or hospitalization for asthma within 8 weeks prior to enrollment, predominant chronic obstructive pulmonary disease (COPD) and bronchiectasis by clinical and/or radiological assessment, history of cough syncope, pregnant or nursing women, and inability to comply with study procedures.
Interventions
DEVICELung Flute
A low frequency wave is generated at the mouth by exhaling through a mouthpiece over a laminar surface (Reed) inside the Lung Flute®. The resulting low frequency acoustic wave that is produced travels retrograde into the lower airways and lung parenchyma and increases mucociliary clearance. Patients expel air with the force required to blow out a single candle. Patients concentrate on producing a low tone through the device while breathing in a proscribed pattern. Twenty repetitions of a single two-breath pattern are performed with the device to complete a diagnostic session.
Sponsors
NYSTAR
Medical Acoustics LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* at least 12 years of age * diagnosis of asthma and no current or previous history of smoking.
Exclusion criteria
* exacerbation of asthma or hospitalization for asthma within 8 weeks prior to enrollment * predominant COPD and bronchiectasis by clinical and/or radiological assessment * history of cough syncope * pregnant or nursing women * not fluent in English * inability to comply with study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Lung Flute Therapy on Asthma | three months | improvement in quality of life as measured by the validated Asthma Control Test (ACT); |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Lung Flute on Asthma | three months | improvement in pulmonary functions |
Other
| Measure | Time frame | Description |
|---|---|---|
| Impact of Lung Flute Therapy on Asthma | three months | * reduction in levels of exhaled nitric oxide (NO) a surrogate marker of pulmonary inflammation * reduction in sputum eosinophils, another surrogate marker of pulmonary |
Countries
United States
Outcome results
None listed