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

Medical Acoustics

Status: Completed

Conditions: COPD

Treatments: Device: Acapella; Device: Lung Flute

Study type: Interventional

Funder types: Industry

Identifiers

NCT00560105

1002

Details and patient eligibility

About

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.

Full description

No further details

Enrollment: 40 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age of over 40 with COPD

Exclusion criteria

• Children,
• New mothers; and
• Women intending to become pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Acapella

Active Comparator group

Description:

The Active Comparator is the Acapella, a OPEP device

Treatment:

Device: Acapella

Lung Flute

Experimental group

Description:

The Active Comparator is the Lung Flute, a new indication of this device

Treatment:

Device: Lung Flute