Clinical trial NCT02003521: Impact of Lung Flute Therapy on Asthma
Official title: Impact of Lung Flute Therapy on Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Persistent Asthma
Keywords: Lung Flute
Lead sponsor: Medical Acoustics LLC
Sponsor class: INDUSTRY
Collaborators: name: NYSTAR
First posted: 2013-12-06
Enrollment: 48
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Impact of Lung Flute Therapy on Asthma
timeFrame: three months
Secondary outcomes:
measure: Impact of Lung Flute on Asthma
timeFrame: three months
Other outcomes:
measure: Impact of Lung Flute Therapy on Asthma
timeFrame: three months
Locations:
city: Buffalo
country: United States
facility: Buffalo General Medical Center Allergy Clinic
state: New York
Study officials:
References:
citation: 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.