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Impact of Lung Flute Therapy on Asthma

M

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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