Impact of Lung Flute Therapy on Asthma
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| ClinicalTrials.gov Identifier: NCT02003521 |
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Recruitment Status :
Completed
First Posted : December 6, 2013
Last Update Posted : October 28, 2014
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Sponsor:
Medical Acoustics LLC
Collaborator:
NYSTAR
Information provided by (Responsible Party):
Medical Acoustics LLC
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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 |
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 |
| 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 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Intervension
Lung Flute
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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 :
- 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 :
- Impact of Lung Flute on Asthma [ Time Frame: three months ]improvement in pulmonary functions
Other Outcome Measures:
- 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
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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
| United States, New York | |
| Buffalo General Medical Center Allergy Clinic | |
| Buffalo, New York, United States, 14203 | |
Sponsors and Collaborators
Medical Acoustics LLC
NYSTAR
Publications:
| 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:
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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 |