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Impact of Lung Flute Therapy on Asthma

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ClinicalTrials.gov Identifier: NCT02003521
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : October 28, 2014
Sponsor:
Collaborator:
NYSTAR
Information provided by (Responsible Party):
Medical Acoustics LLC

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.

Condition or disease Intervention/treatment
Persistent Asthma 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.

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Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Lung Flute Therapy on Asthma
Study Start Date : November 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Impact of Lung Flute on Asthma [ Time Frame: three months ]
    improvement in pulmonary functions


Other Outcome Measures:
  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


Biospecimen Retention:   Samples With DNA
Sputum


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003521


Locations
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United States, New York
Buffalo General Medical Center Allergy Clinic
Buffalo, New York, United States, 14203
Sponsors and Collaborators
Medical Acoustics LLC
NYSTAR
Publications:
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.

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Responsible Party: Medical Acoustics LLC
ClinicalTrials.gov Identifier: NCT02003521    
Other Study ID Numbers: 426195-4
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014
Keywords provided by Medical Acoustics LLC:
Lung Flute
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases