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NCT Number: NCT02003521

Impact of Lung Flute Therapy on Asthma

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.

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Key information

Conditions

Persistent Asthma

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Buffalo General Medical Center Allergy Clinic

Buffalo, New York, 14203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lung Flute

Device

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.

Primary outcomes

  1. Impact of Lung Flute Therapy on Asthma

    Time frame: three months

    improvement in quality of life as measured by the validated Asthma Control Test (ACT);

Secondary outcomes

  1. Impact of Lung Flute on Asthma

    Time frame: three months

    improvement in pulmonary functions

Other outcomes

  1. Impact of Lung Flute Therapy on Asthma

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medical Acoustics LLC

Industry

Collaborators

  • NYSTAR

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2013
Registry last updated
Oct 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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