Back to resultsA Short-term Comparative Study of Aerosure for Airway Clearance in Patients With Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Terminated
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Aerosure at 15 Hz
Aerosure at 25 Hz
Sham Aerosure
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring Cystic Fibrosis, Neural respiratory drive, Airway clearance technique, Expectoration, Positive expiratory pressure device
Eligibility 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
Sites / Locations
- King's College Hospital, Bessemer Road, Denmark Hill
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Sham Comparator
Arm Label
Aerosure 15 Hz
Aerosure 25 Hz
Aerosure sham
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Wet weight of sputum expectorated during treatment session
Secondary Outcome Measures
Change in FEV1
Change in VC
Change in oxygen saturation
Change in ventilation
Change in neural respiratory drive
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01923753
Brief Title
A Short-term Comparative Study of Aerosure for Airway Clearance in Patients With Cystic Fibrosis
Official Title
A Short-term Comparative Study of Aerosure for Airway Clearance in Patients With Cystic Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit sufficient patients within reasonable timeframe
Study Start Date
September 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actegy Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic Fibrosis, Neural respiratory drive, Airway clearance technique, Expectoration, Positive expiratory pressure device
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aerosure 15 Hz
Arm Type
Experimental
Arm Description
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.
Arm Title
Aerosure 25 Hz
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Aerosure sham
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Aerosure at 15 Hz
Intervention Description
Active Aerosure HFAO device operating at lower frequency
Intervention Type
Device
Intervention Name(s)
Aerosure at 25 Hz
Intervention Description
Active Aerosure HFAO device operating at higher frequency
Intervention Type
Device
Intervention Name(s)
Sham Aerosure
Intervention Description
Deactivated but identical Aerosure HFAO device
Primary Outcome Measure Information:
Title
Wet weight of sputum expectorated during treatment session
Time Frame
up to 30 minutes after treatment
Secondary Outcome Measure Information:
Title
Change in FEV1
Time Frame
immediately before and up to 30 minutes after treatment
Title
Change in VC
Time Frame
immediately before and up to 30 minutes after treatment
Title
Change in oxygen saturation
Time Frame
continuously from 3 minutes prior to treatment and until 3 minutes after treatment
Title
Change in ventilation
Time Frame
5 minutes prior to treatment, immediately following treatment and 30 minutes after treatment
Title
Change in neural respiratory drive
Time Frame
5 minutes prior to treatment and 30 minutes after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Moxham, MD
Organizational Affiliation
King's College Hospital NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
King's College Hospital, Bessemer Road, Denmark Hill
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Short-term Comparative Study of Aerosure for Airway Clearance in Patients With Cystic Fibrosis
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