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

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ClinicalTrials.gov Identifier: NCT01923753
Recruitment Status : Terminated (Unable to recruit sufficient patients within reasonable timeframe)
First Posted : August 16, 2013
Last Update Posted : June 3, 2016
Sponsor:
Information provided by (Responsible Party):
Actegy Ltd.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cystic Fibrosis Device: Aerosure at 15 Hz Device: Aerosure at 25 Hz Device: Sham Aerosure Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Short-term Comparative Study of Aerosure for Airway Clearance in Patients With Cystic Fibrosis
Study Start Date : September 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Wet weight of sputum expectorated during treatment session [ Time Frame: up to 30 minutes after treatment ]

Secondary Outcome Measures :
  1. Change in FEV1 [ Time Frame: immediately before and up to 30 minutes after treatment ]
  2. Change in VC [ Time Frame: immediately before and up to 30 minutes after treatment ]
  3. Change in oxygen saturation [ Time Frame: continuously from 3 minutes prior to treatment and until 3 minutes after treatment ]
  4. Change in ventilation [ Time Frame: 5 minutes prior to treatment, immediately following treatment and 30 minutes after treatment ]
  5. Change in neural respiratory drive [ Time Frame: 5 minutes prior to treatment and 30 minutes after treatment ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01923753


Locations
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United Kingdom
King's College Hospital, Bessemer Road, Denmark Hill
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Actegy Ltd.
Investigators
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Principal Investigator: John Moxham, MD King's College Hospital NHS Trust
More Information
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Responsible Party: Actegy Ltd.
ClinicalTrials.gov Identifier: NCT01923753    
Other Study ID Numbers: ACACIA-01
First Posted: August 16, 2013    Key Record Dates
Last Update Posted: June 3, 2016
Last Verified: June 2016
Keywords provided by Actegy Ltd.:
Cystic Fibrosis
Neural respiratory drive
Airway clearance technique
Expectoration
Positive expiratory pressure device
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases