Impact of Lung Flute Therapy on Asthma
| Status: | Completed |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 11/8/2014 |
| Start Date: | November 2013 |
| End Date: | June 2014 |
| Contact: | Stanley A Schwartz, M.D. PhD |
| Email: | sasimmun@buffalo.edu |
| Phone: | 716-859-2260 |
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.
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.
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
