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.

Study Overview

• Status: Completed
• Conditions: Persistent Asthma
• Intervention / Treatment: Device: Lung Flute

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.

• Study Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14203
      • Buffalo General Medical Center Allergy Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

We are seeking patients diagnosed with asthma. All subjects will have already been screened as a consequence of their being established asthma patients at the clinical sites. Patients will be identified and screened by their attending physician who will notify the investigators. The investigators are responsible for recruiting identified subjects.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Intervension; Lung Flute

Device: Lung 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of Lung Flute Therapy on Asthma	improvement in quality of life as measured by the validated Asthma Control Test (ACT);	three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of Lung Flute on Asthma	improvement in pulmonary functions	three months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of Lung Flute Therapy on Asthma	reduction in levels of exhaled nitric oxide (NO) a surrogate marker of pulmonary inflammation; reduction in sputum eosinophils, another surrogate marker of pulmonary	three months

Collaborators and Investigators

• Sponsor: Medical Acoustics LLC
• Collaborators: NYSTAR

Publications and helpful links

General Publications

• Fujita A, Murata K, Takamori M. Novel method for sputum induction using the Lung Flute in patients with suspected pulmonary tuberculosis. Respirology. 2009 Aug;14(6):899-902. doi: 10.1111/j.1440-1843.2009.01584.x. Epub 2009 Jul 29.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: November 24, 2013
• First Submitted That Met QC Criteria: December 2, 2013
• First Posted (Estimate): December 6, 2013

Study Record Updates

• Last Update Posted (Estimate): October 28, 2014
• Last Update Submitted That Met QC Criteria: October 27, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Lung Flute
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 426195-4