Randomized Controlled Eight-Week Study of the Safety and Efficacy of the Lung Flute

COPD Clinical Trial

Official title:

A Proof of Principal Randomized Controlled Eight-Week Study of the Safety and Efficacy of the Lung Flute in Adults With Chronic Obstructive Pulmonary Disease. A FDA 510(k) Equivalency Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00560105
• Other study ID #: 1002
• Status: Completed
• Phase: N/A
• First received: November 15, 2007
• Last updated: March 4, 2015
• Start date: November 2007
• Est. completion date: December 2008

Study information

• Verified date: March 2015
• Source: Medical Acoustics LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This is an eight-week, randomized, controlled, two arm parallel study. The study consists of, a screening visit, two weeks of intervention-free run-in randomization, clinic visits week 0, 1, 2, 4, 6, and 8 weeks during the intervention period to collect 24 hour sputum and to confirm techniques of device use and entries into daily diaries. Twenty-four (24) hour sputum samples will be collected and weighed at each clinic visit. In addition to clinic visits, subjects will be expected to make daily diary entries of COPD symptoms. Clinical evaluation will include adverse event surveillance, and St. Georges Respiratory questionnaire.

Description:

No further details

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Age of over 40 with COPD

Exclusion Criteria:

• Children,

• New mothers; and

• Women intending to become pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• Lung Flute
8 weeks home use, twice daily
• Acapella
8 weeks home use, twice daily

Locations

Country	Name	City	State
United States	VA Western NY Healthcare System	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Medical Acoustics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Efficacy of the Lung Flute Versus the Acapella for the Treatment of COPD in Adults. Twenty-four (24) Hour Dry Sputum Weight	In order to test the overall treatment effect on dry sputum weight over the course of the study, mixed effects analysis were performed. These models allow us to account for the longitudinal nature of the data. We assumed that the observations collected within each patient were correlated; however, observations collected across patients were assumed to be independent. Dry sputum weights obtained prior to and at randomization were regarded as baseline measurements, while those obtained at week 1, 2, 4, 6 and 8 were examined for treatment effects.	8 weeks	Yes
Secondary	FEV1 - Baseline and Device Comparisons	Spirometric data was collected primarily to document safety of the interventions. Pre- and Post-bronchodilator spirometry was obtained at the randomization visit and at Week 8.	8 weeks	No
Secondary	Quality of Life Questionnaire/Daily Diary	St. George's Respiratory Questionnaire (SGRQ) is a well validated, widely used health status questionnaire specific for COPD. Its minimum important difference (MID) is 4 units. Unit of measure: 0 to 100 (100 = more limitation)	8 weeks	Yes
Secondary	Change in CCQ Score	The COPD Clinical Questionnaire (CCQ) is an objective validated tool to assess COPD symptoms. CCQ was measured at the randomization visit and at the end of the study visit at week 8. The CCQ is scaled 1 to 5. Five indicating no symptoms.	8 weeks	No