Impact of Lung Flute Therapy on Asthma

Completed

• Conditions: Persistent Asthma
• Interventions: Device: Lung Flute

• Registration Number: NCT02003521
• Lead Sponsor: Medical Acoustics LLC

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 Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-24
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-06
• Status Verified: 2014-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-10-27
• Last Update Posted: 2014-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intervension	Lung Flute	Lung Flute

Primary Outcome Measures

Name	Time	Method
Impact of Lung Flute Therapy on Asthma	three months	improvement in quality of life as measured by the validated Asthma Control Test (ACT);

Secondary Outcome Measures

Name	Time	Method
Impact of Lung Flute on Asthma	three months	improvement in pulmonary functions

Trial Locations

Locations (1)

Buffalo General Medical Center Allergy Clinic; 🇺🇸 Buffalo, New York, United States