Impact of Lung Flute Therapy on Asthma

NCT02003521 | Completed

• 1 other identifier: 426195-4
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Persistent Asthma

Keywords

Lung Flute

Outcome Measures

Primary Outcomes (1)

• Impact of Lung Flute Therapy on Asthma

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

  three months

Secondary Outcomes (1)

• Impact of Lung Flute on Asthma

  three months

Other Outcomes (1)

• Impact of Lung Flute Therapy on Asthma

  three months

Study Arms (1)

Intervension

Lung Flute

Device: Lung Flute

Interventions

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.

Intervension

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• at least 12 years of age
• diagnosis of asthma and no current or previous history of smoking.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical Acoustics LLC: lead
• NYSTAR: collaborator

Study Sites (1)

Buffalo General Medical Center Allergy Clinic

Buffalo, New York, 14203, United States

Location

Related Publications (1)

• 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.

  PMID: 19659832 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Sputum

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2013
• First Posted: December 6, 2013
• Study Start: November 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 28, 2014

Record last verified: 2014-10

Locations

US (1)