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History of Changes for Study: NCT02003521
Impact of Lung Flute Therapy on Asthma
Latest version (submitted October 27, 2014) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 2, 2013 None (earliest Version on record)
2 October 27, 2014 Recruitment Status, Study Status, Contacts/Locations and Study Design
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Study NCT02003521
Submitted Date:  December 2, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: 426195-4
Brief Title: Impact of Lung Flute Therapy on Asthma
Official Title: Impact of Lung Flute Therapy on Asthma
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2013
Overall Status: Recruiting
Study Start: November 2013
Primary Completion: May 2014 [Anticipated]
Study Completion: June 2014 [Anticipated]
First Submitted: November 24, 2013
First Submitted that
Met QC Criteria:
December 2, 2013
First Posted: December 6, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 2, 2013
Last Update Posted: December 6, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Medical Acoustics LLC
Responsible Party: Sponsor
Collaborators: NYSTAR
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Persistent Asthma
Keywords: Lung Flute
Open or close this module Study Design
Study Type: Observational
Observational Study Model: Cohort
Time Perspective: Prospective
Biospecimen Retention: Samples With DNA
Biospecimen Description: Sputum
Enrollment: 48 [Anticipated]
Number of Groups/Cohorts 1
Open or close this module Groups and Interventions
Groups/Cohorts Interventions
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.
Open or close this module Outcome Measures
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
Open or close this module Eligibility
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.
Sampling Method: Non-Probability Sample
Minimum Age: 12 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Stanley A Schwartz, M.D. PhD
Telephone: 716-859-2260
Email: sasimmun@buffalo.edu
Central Contact Backup: Pam Anderson, BS
Telephone: 716-888-4841
Email: pka@buffalo.edu
Locations: United States, New York
Buffalo General Medical Center Allergy Clinic
[Recruiting]
Buffalo, New York, United States, 14203
Contact:Contact: Stanley M Schwartz, MD PhD 716-859-2260 mailto:sasimmun@buffalo.edu
Contact:Contact: James Cumella, MD
Contact:Principal Investigator: Stanley A Schwartz, MD PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: 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. PubMed 19659832
Links:
Available IPD/Information:

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