Impact of Lung Flute Therapy on Asthma

Medical Acoustics

Status: Completed

Conditions: Persistent Asthma

Treatments: Device: Lung Flute

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT02003521

426195-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

48 participants in 1 patient group

Intervension

Description:

Lung Flute

Treatment:

Device: Lung Flute