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

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 |
- Wet weight of sputum expectorated during treatment session [ Time Frame: up to 30 minutes after treatment ]
- Change in FEV1 [ Time Frame: immediately before and up to 30 minutes after treatment ]
- Change in VC [ Time Frame: 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 ]
- Change in ventilation [ Time Frame: 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 ]

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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 |
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

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
United Kingdom | |
King's College Hospital, Bessemer Road, Denmark Hill | |
London, United Kingdom, SE5 9RS |
Principal Investigator: | John Moxham, MD | King's College Hospital NHS Trust |
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 |
Cystic Fibrosis Neural respiratory drive Airway clearance technique Expectoration Positive expiratory pressure device |
Cystic Fibrosis Fibrosis Pathologic Processes Pancreatic Diseases Digestive System Diseases |
Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases |