Cystic FibrosisPhase 2NCT01923753
A Short-term Comparative Study of Aerosure for Airway Clearance in Patients With Cystic Fibrosis
A Phase 2 study testing Aerosure at 15 Hz and Aerosure at 25 Hz in people with Cystic Fibrosis, run by Actegy Ltd. at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Aerosure at 15 Hz and Aerosure at 25 Hz
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to Nov 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Acute respiratory failure
- Haemodynamic instability (including severe right heart failure with hypotension)
- Current severe haemoptysis
- Ineffective cough
- Rib fractures
- Pregnancy
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College Hospital, Bessemer Road, Denmark Hill
London, SE5 9RS
About this study
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
- Cystic Fibrosis
- Being tested
- Aerosure at 15 Hz, Aerosure at 25 Hz, Sham Aerosure
- Keywords
- Cystic Fibrosis, Neural respiratory drive, Airway clearance technique, Expectoration, Positive expiratory pressure device
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerosure at 15 HzDevice
Active Aerosure HFAO device operating at lower frequency
Aerosure at 25 HzDevice
Active Aerosure HFAO device operating at higher frequency
Sham AerosureDevice
Deactivated but identical Aerosure HFAO device
| Study group | Role | What they receive |
|---|---|---|
| Aerosure 15 Hz | Experimental | 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. Receives: Device: Aerosure at 15 Hz |
| Aerosure 25 Hz | Active comparator | 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. Receives: Device: Aerosure at 25 Hz |
| Aerosure sham | Sham comparator | 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. Receives: Device: Sham Aerosure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wet weight of sputum expectorated during treatment session
Measured: up to 30 minutes after treatment
Secondary outcomes (5)
Change in FEV1
Measured: immediately before and up to 30 minutes after treatment
Change in VC
Measured: immediately before and up to 30 minutes after treatment
Change in oxygen saturation
Measured: continuously from 3 minutes prior to treatment and until 3 minutes after treatment
Change in ventilation
Measured: 5 minutes prior to treatment, immediately following treatment and 30 minutes after treatment
Change in neural respiratory drive
Measured: 5 minutes prior to treatment and 30 minutes after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: Unable to recruit sufficient patients within reasonable timeframe
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actegy Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Moxham, MD, Principal investigator, King's College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923753
- Sponsor's protocol ID
- ACACIA-01
- Status last verified
- Jun 2016
- First submitted
- 13 Aug 2013
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Short-term Comparative Study of Aerosure for Airway Clearance in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01923753
- Acronym / sponsor ID
- ACACIA-01
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Neural respiratory drive, Airway clearance technique, Expectoration, Positive expiratory pressure device
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit sufficient patients within reasonable timeframe
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Actegy Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 16 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aerosure 15 Hz | Experimental | Device: Aerosure at 15 HzAll 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. |
| Aerosure 25 Hz | Active comparator | Device: Aerosure at 25 HzAll 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. |
| Aerosure sham | Sham comparator | Device: Sham AerosureAll 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (21 listed)
- Acute respiratory failure
- Haemodynamic instability (including severe right heart failure with hypotension)
- Current severe haemoptysis
- Ineffective cough
- Rib fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerosure at 15 HzActive Aerosure HFAO device operating at lower frequency | Device | Aerosure 15 Hz |
| Aerosure at 25 HzActive Aerosure HFAO device operating at higher frequency | Device | Aerosure 25 Hz |
| Sham AerosureDeactivated but identical Aerosure HFAO device | Device | Aerosure sham |
Primary outcome
Wet weight of sputum expectorated during treatment session
Time frame: up to 30 minutes after treatment
5 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Unable to recruit sufficient patients within reasonable timeframe). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Moxham, MD principal investigator
King's College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aerosure at 15 Hz and Aerosure at 25 Hz in people with Cystic Fibrosis, run by Actegy Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit sufficient patients within reasonable timeframe). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wet weight of sputum expectorated during treatment session (time frame: up to 30 minutes after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2016.