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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

Tracking Information
First Submitted Date November 24, 2013
First Posted Date December 6, 2013
Last Update Posted Date October 28, 2014
Study Start Date November 2013
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 2, 2013)
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);
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 2, 2013)
Impact of Lung Flute on Asthma [ Time Frame: three months ]
improvement in pulmonary functions
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: December 2, 2013)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Impact of Lung Flute Therapy on Asthma
Official Title Impact of Lung Flute Therapy on Asthma
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Sputum
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.
Condition 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.
Study Groups/Cohorts Intervension
Lung Flute
Intervention: Device: Lung Flute
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 2, 2013)
48
Original Estimated Enrollment Same as current
Actual Study Completion Date October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02003521
Other Study ID Numbers 426195-4
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Medical Acoustics LLC
Original Responsible Party Same as current
Current Study Sponsor Medical Acoustics LLC
Original Study Sponsor Same as current
Collaborators NYSTAR
Investigators Not Provided
PRS Account Medical Acoustics LLC
Verification Date October 2014