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

June 2, 2016 updated by: Actegy Ltd.
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • King's College Hospital, Bessemer Road, Denmark Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A diagnosis of CF (established by genotype or sweat sodium >70mmol/l or sweat chloride of >60 mmol/l
  • Admitted to King's College Hospital within 48 hours of an acute infective pulmonary exacerbation characterised by an increase in respiratory symptoms requiring intravenous antibiotics

Exclusion Criteria:

  • Acute respiratory failure
  • Haemodynamic instability (including severe right heart failure with hypotension)
  • Current severe haemoptysis
  • Ineffective cough
  • Rib fractures
  • Pregnancy
  • Current or recent pneumothorax
  • Epilepsy
  • Current pulmonary embolism
  • Oesophageal varices
  • Recent thoracic upper gastro-intestinal tract or facial surgery
  • Active tuberculosis
  • Recent brain, eye, ear, ENT surgery
  • Myocardial infarction
  • Ascending aortic aneurysm
  • Acute diarrhoea
  • Pulmonary embolism
  • Angina
  • Severe hypertension (systolic >200 mm Hg, diastolic >120 mm Hg)
  • Confusion/dementia
  • Inability to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aerosure 15 Hz

All subjects receive an active device operating at a specific frequency, active device operating at another specific frequency and sham device (disabled):

Aerosure at 15 Hz; Aerosure at 25 Hz; Sham Aerosure. Order of presentation is randomised.
Device: Aerosure at 15 Hz
Active Aerosure HFAO device operating at lower frequency
Active Comparator: Aerosure 25 Hz

All subjects receive an active device operating at a specific frequency, active device operating at another specific frequency and sham device (disabled):

Aerosure at 15 Hz; Aerosure at 25 Hz; Sham Aerosure.
Device: Aerosure at 25 Hz
Active Aerosure HFAO device operating at higher frequency
Sham Comparator: Aerosure sham

All subjects receive an active device operating at a specific frequency, active device operating at another specific frequency and sham device (disabled):

Aerosure at 15 Hz; Aerosure at 25 Hz; Sham Aerosure.
Device: Sham Aerosure
Deactivated but identical Aerosure HFAO device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Wet weight of sputum expectorated during treatment session
Time Frame: up to 30 minutes after treatment
up to 30 minutes after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in FEV1
Time Frame: immediately before and up to 30 minutes after treatment
immediately before and up to 30 minutes after treatment
Change in VC
Time Frame: immediately before and up to 30 minutes after treatment
immediately before and up to 30 minutes after treatment
Change in oxygen saturation
Time Frame: continuously from 3 minutes prior to treatment and until 3 minutes after treatment
continuously from 3 minutes prior to treatment and until 3 minutes after treatment
Change in ventilation
Time Frame: 5 minutes prior to treatment, immediately following treatment and 30 minutes after treatment
5 minutes prior to treatment, immediately following treatment and 30 minutes after treatment
Change in neural respiratory drive
Time Frame: 5 minutes prior to treatment and 30 minutes after treatment
5 minutes prior to treatment and 30 minutes after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actegy Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 13, 2013

First Submitted That Met QC Criteria

August 14, 2013

First Posted (Estimate)

August 16, 2013

Study Record Updates

Last Update Posted (Estimate)

June 3, 2016

Last Update Submitted That Met QC Criteria

June 2, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACACIA-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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