Impact of Lung Flute Therapy on Asthma

Persistent Asthma Clinical Trial

Official title:

Impact of Lung Flute Therapy on Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02003521
• Other study ID #: 426195-4
• Status: Completed
• Phase: N/A
• First received: November 24, 2013
• Last updated: October 27, 2014
• Start date: November 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Medical Acoustics LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Persistent Asthma

Intervention

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.

Locations

Country	Name	City	State
United States	Buffalo General Medical Center Allergy Clinic	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
Medical Acoustics LLC	NYSTAR

Country where clinical trial is conducted

United States, 

References & Publications (1)

1. Fujita A. Murata K. Takamori M. Novel method for sputum induction using the Lung Flute in patients with suspected pulmonary tuberculosis. Respirology. 14(6):899-902, 2009. 2. Fujita A. Murata K. Takamori M. Wada A. A small audio device may be alternative to hypertonic saline inhalation for sputum induction in patients with pulmonary tuberculosis. Abstract presented at the European Respiratory Society, Berlin, 2008.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	Impact of Lung Flute Therapy on Asthma	improvement in quality of life as measured by the validated Asthma Control Test (ACT);	three months	No
Secondary	Impact of Lung Flute on Asthma	improvement in pulmonary functions	three months	No