MedTrace Logo

A Short-term Comparative Study of Aerosure for Airway Clearance in Patients With Cystic Fibrosis

NCT01923753 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2016-06-03

No results posted yet for this study

Summary

This is a double-blind randomised controlled crossover study to investigate whether high frequency airflow oscillation (HFAO), delivered using Aerosure, improves sputum clearance in patients admitted to hospital with infective exacerbations of cystic fibrosis (CF). This study will test the hypothesis that the wet weight of sputum expectorated is greater following the use of Aerosure than following the use of a sham Aerosure device.

Conditions

Interventions

DEVICE

Aerosure at 15 Hz

Active Aerosure HFAO device operating at lower frequency

DEVICE

Aerosure at 25 Hz

Active Aerosure HFAO device operating at higher frequency

DEVICE

Sham Aerosure

Deactivated but identical Aerosure HFAO device

Sponsors & Collaborators

  • Actegy Ltd.

    lead INDUSTRY

Principal Investigators

  • John Moxham, MD · King's College Hospital NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01923753 on ClinicalTrials.gov