Cystic FibrosisNCT02721498
Improving Outcome Measures For Adult CF ACT Trials
A study testing Airway clearance session using the Active Cycle of Breathing Techniques (ACBT) and Rest period in people with Cystic Fibrosis, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This is a randomised controlled cross-over trial involving adult cystic fibrosis (CF) patients from the Royal Brompton Hospital, London investigating outcome measures used in airway clearance trials. Each participant will attend the research facility for two visits. 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?
- Airway clearance session using the Active Cycle of Breathing Techniques (ACBT) and Rest period
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2016to Dec 2021
- Phase
- Interventional
- 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
- Diagnosis of CF (confirmed by standard criteria)
- Sixteen years of age or over
- Patients in a stable state (characterised by no required therapy changes within 28 days of visit and patient symptoms)
Who cannot join
- Current infective exacerbation or reduction in lung function requiring therapeutic intervention
- Current moderate haemoptysis (greater than streaking in the sputum)
- Current dependency on positive pressure support with ACT
- Previous history of spontaneous rib fractures
- Pregnancy
- Inability to give consent for treatment or measurement
Show all 9Show fewer
- Current participation in another interventional study
- Current dependency upon non-invasive ventilation
- Current dependency upon oxygen therapy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Brompton Hospital
London, Greater London, SW3 6NP
About this study
Official title: Improving Outcome Measures For Physiotherapy Trials of Airway Clearance in Adults With Cystic Fibrosis
This is a randomised controlled cross-over trial involving adult cystic fibrosis (CF) patients from the Royal Brompton Hospital, London investigating outcome measures used in airway clearance trials.
Each participant will attend the research facility for two visits. Participants will be randomly assigned to the order that they perform the study sessions. Visit A will involve a period of rest for up to 60 minutes in-between assessments; Visit B will involve a session of airway clearance (ACT) utilising ACBT supervised by a specialist physiotherapist in adult CF.
Read more
Participants will perform the outcome measure (OM) tests of impulse oscillation system (IOS), lung clearance index (LCI), and spirometry, then either rest (visit A) or perform a supervised ACBT session (visit B) using electronic impedance tomography (EIT) during the session. IOS, LCI and spirometry will be repeated after the session. Sputum will be collected throughout the ACT or rest sessions and for 30 minutes after each of these sessions is completed. Questionnaires asking patient views on the OMs will be completed at the end of each study visit.
Analysis will be based upon differences in outcome measures and in-between study days.
Read the detailed description
Research Question: Does the use of a new assessment tool box (Electronic Impedance Tomography (EIT), Lung Clearance Index (LCI), Impulse Oscillation System (IOS)) give results that are more sensitive to change for the effect of an airway clearance technique (ACT) (the Active Cycle of Breathing Techniques (ACBT)) while having low variability and good repeatability in stable adult patients with cystic fibrosis (CF) than the traditional gold standard outcome measures of forced expiratory volume in one second (FEV1) and sputum wet weight?
Hypothesis: The use of a new outcome assessment tool box will allow more sensitive information about the effects of ACTs in stable adult patients with CF than the current gold standard measures.
This is a randomised controlled cross-over trial involving adult cystic fibrosis (CF) patients from the Royal Brompton Hospital, London. Participants will be their own controls. Each participant will attend the research facility for two visits. Prior to starting the study assessment session participants will be questioned to ensure they are in a stable state of their disease (characterised by symptoms and having had no treatment changes for 28 days prior to the visit). All participants will continue with the timing and prescribed dosing of all inhaled medications as directed prior to the study. Subjects will be their own controls. Subjects will be randomly assigned to the order that they perform the study sessions. Visit A will involve a period of rest for up to 60 minutes in-between assessments; Visit B will involve a session of airway clearance (ACT) utilising the Active Cycle of Breathing Techniques (ACBT) supervised by a specialist physiotherapist in adult CF. The ACT session will last for thirty minutes minimum, to 60 minutes maximum until a consensus is reached between participant and physiotherapist that the participant's chest is clear.
Subjects will perform the OM tests of impulse oscillation system (IOS), lung clearance index (LCI), and spirometry, then either rest (visit A) or perform a supervised ACBT session (visit B) using electronic impedance tomography (EIT) during the session. IOS, LCI and spirometry will be repeated immediately after the session. Sputum will be collected throughout the ACT or rest sessions and for 30 minutes after each of these sessions is completed. Questionnaires asking patient views on the OMs will be given for completion after the last OM test is completed on each study visit.
There are no planned follow up measurements for participants in this study design.
All usual medications will be permitted for this study. Attention will be paid to mucoactive drugs (Pulmozyme®, Mannitol®, Hypertonic saline) to ensure the same frequency and dosing of inhalations for both study visits.
Data will be analysed in 3 groups based upon disease severity. Analysis will be based upon differences in outcome measures and in-between study days.
- Conditions
- Cystic Fibrosis
- Being tested
- Airway clearance session using the Active Cycle of Breathing Techniques (ACBT), Rest period
- Keywords
- Respiratory Physiotherapy, Airway clearance techniques, Outcome measures
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airway clearance session using the Active Cycle of Breathing Techniques (ACBT)Procedure or surgery
An airway clearance technique incorporating thoracic expansion exercises, breathing control (normal diaphragmatic breathing) and the forced expiration technique (or huffing)
Rest periodOther
A 30-60 minute of resting
| Study group | Role | What they receive |
|---|---|---|
| Visit A | Active comparator | Rest period for 30-60 minutes Receives: Other: Rest period |
| Visit B | Active comparator | Airway clearance session utilising the Active Cycle of Breathing techniques (ACBT) supervised by a specialist physiotherapist for 30-60 minutes. Receives: Procedure: Airway clearance session using the Active Cycle of Breathing Techniques (ACBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Lung Clearance Index
This is a technique which involves breathing quietly through a tube whilst wearing nose clips. The test measures harmless tracer gases which are breathed in and out and measured by a sensitive gas-detection system. The LCI is calculated based on how long it takes for the gas to be breathed out from the lungs, and it shows if there are areas within the lung that are working less efficiently than others, for example when areas of the lung are clogged with mucus.
Measured: Immediately pre-intervention and immediately post-intervention
Change in Forced Expiratory Volume in One Second
A forced expiratory manoeuvre into a spirometer (value derived from 1 second blow)
Measured: Immediately pre-intervention and immediately post-intervention
Electronic Impedance Tomography
This technique involves wearing a belt around the chest which has electrodes attached to it. Undetectable alternating electrical currents are then applied to the electrodes, which the participant will not be able to feel. The machine measures how easy or difficult it is for that current to travel through the lungs and any differences are calculated, giving a picture of the ventilation of the lung.
Measured: During intervention
Change in Impulse Oscillation System
The Impulse Oscillation system is a non-invasive technique where the participant breathes normally through a mouthpiece whilst wearing a nose clip, into a machine which produces small pressure vibrations (oscillations). The machine measures these vibrations and any changes to them to give an idea of obstructions to the airways, for example any mucus clogging.
Measured: Immediately pre-intervention and immediately post-intervention
Sputum Wet Weight
Amount of sputum expectorated will be measured in a pre-weighed pot
Measured: During intervention and for 30 minutes post-intervention
Secondary outcomes (6)
Change in Forced Vital Capacity
A forced expiratory manoeuvre into a spirometer (value derived from full expiration)
Measured: Immediately pre-intervention and immediately post-intervention
Change in Forced Expiratory Flow at 25% of Forced Vital Capacity
A forced expiratory manoeuvre into a spirometer (value derived from full expiration)
Measured: Immediately pre-intervention and immediately post-intervention
Change in Forced Expiratory Flow at 50% of Forced Vital Capacity
A forced expiratory manoeuvre into a spirometer (value derived from full expiration)
Measured: Immediately pre-intervention and immediately post-intervention
Change in Forced Expiratory Flow at 75% of Forced Vital Capacity
A forced expiratory manoeuvre into a spirometer (value derived from full expiration)
Measured: Immediately pre-intervention and immediately post-intervention
Oxygen saturation measurements
Completed via a finger probe connected to a pulse oximeter which will record saturations over the whole session.
Measured: During interventions
Patient feedback questionnaire
A patient reported outcome investigating the opinions of participants on each of the OMs completed during the trial using open and Likert scale questions
Measured: Straight after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Nicholas J Simmonds, MD(Res) FRCP, Principal investigator, The Royal Brompton & Harefield NHS Foundation Trust and Imperial College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721498
- Sponsor's protocol ID
- 2016CF001B
- Status last verified
- Dec 2021
- First submitted
- 9 Mar 2016
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kent L, Reix P, Innes JA, Zielen S, Le Bourgeois M, Braggion C, Lever S, Arets HG, Brownlee K, Bradley JM, Bayfield K, O'Neill K, Savi D, Bilton D, Lindblad A, Davies JC, Sermet I, De Boeck K; European Cystic Fibrosis Society Clinical Trial Network (ECFS-CTN) Standardisation Committee. Lung clearance index: evidence for use in clinical trials in cystic fibrosis. J Cyst Fibros. 2014 Mar;13(2):123-38. doi: 10.1016/j.jcf.2013.09.005. Epub 2013 Dec 5.
PubMed 24315208Bradley JM, Moran FM, Elborn JS. Evidence for physical therapies (airway clearance and physical training) in cystic fibrosis: an overview of five Cochrane systematic reviews. Respir Med. 2006 Feb;100(2):191-201. doi: 10.1016/j.rmed.2005.11.028.
PubMed 16412951Osman LP, Roughton M, Hodson ME, Pryor JA. Short-term comparative study of high frequency chest wall oscillation and European airway clearance techniques in patients with cystic fibrosis. Thorax. 2010 Mar;65(3):196-200. doi: 10.1136/thx.2008.111492. Epub 2009 Aug 23.
PubMed 19703826Pfleger A, Steinbacher M, Schwantzer G, Weinhandl E, Wagner M, Eber E. Short-term effects of physiotherapy on ventilation inhomogeneity in cystic fibrosis patients with a wide range of lung disease severity. J Cyst Fibros. 2015 Sep;14(5):627-31. doi: 10.1016/j.jcf.2014.12.017. Epub 2015 Jan 19.
PubMed 25612899Wettstein M, Radlinger L, Riedel T. Effect of different breathing aids on ventilation distribution in adults with cystic fibrosis. PLoS One. 2014 Sep 15;9(9):e106591. doi: 10.1371/journal.pone.0106591. eCollection 2014.
PubMed 25222606Horsley A. 2009. 'Non-Invasive Assessment of Ventilation Maldistribution in Lung Disease Using Multiple Breath Inert Gas Washouts', University of Edinburgh, UK
Hurt, K. 2013. 'Small Airways Assessment In Adult Cystic Fibrosis', Imperial College (National Heart and Lung Institute), UK
Stanford G, Davies JC, Usmani O, Banya W, Charman S, Jones M, Simmonds NJ, Bilton D. Investigating outcome measures for assessing airway clearance techniques in adults with cystic fibrosis: protocol of a single-centre randomised controlled crossover trial. BMJ Open Respir Res. 2020 Oct;7(1):e000694. doi: 10.1136/bmjresp-2020-000694.
PubMed 33020113
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcome Measures For Physiotherapy Trials of Airway Clearance in Adults With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02721498
- Acronym / sponsor ID
- 2016CF001B
- Conditions
- Cystic Fibrosis
- Keywords
- Respiratory Physiotherapy, Airway clearance techniques, Outcome measures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 29 Mar 2016 (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 randomised controlled cross-over trial involving adult cystic fibrosis (CF) patients from the Royal Brompton Hospital, London investigating outcome measures used in airway clearance trials.
Each participant will attend the research facility for two visits. Participants will be randomly assigned to the order that they perform the study sessions. Visit A will involve a period of rest for up to 60 minutes in-between assessments; Visit B will involve a session of airway clearance (ACT) utilising ACBT supervised by a specialist physiotherapist in adult CF.
Participants will perform the outcome measure (OM) tests of impulse oscillation system (IOS), lung clearance index (LCI), and spirometry, then either rest (visit A) or perform a supervised ACBT session (visit B) using electronic impedance tomography (EIT) during the session. IOS, LCI and spirometry will be repeated after the session. Sputum will be collected throughout the ACT or rest sessions and for 30 minutes after each of these sessions is completed. Questionnaires asking patient views on the OMs will be completed at the end of each study visit.
Analysis will be based upon differences in outcome measures and in-between study days.
Detailed description
Research Question: Does the use of a new assessment tool box (Electronic Impedance Tomography (EIT), Lung Clearance Index (LCI), Impulse Oscillation System (IOS)) give results that are more sensitive to change for the effect of an airway clearance technique (ACT) (the Active Cycle of Breathing Techniques (ACBT)) while having low variability and good repeatability in stable adult patients with cystic fibrosis (CF) than the traditional gold standard outcome measures of forced expiratory volume in one second (FEV1) and sputum wet weight?
Hypothesis: The use of a new outcome assessment tool box will allow more sensitive information about the effects of ACTs in stable adult patients with CF than the current gold standard measures.
This is a randomised controlled cross-over trial involving adult cystic fibrosis (CF) patients from the Royal Brompton Hospital, London. Participants will be their own controls. Each participant will attend the research facility for two visits. Prior to starting the study assessment session participants will be questioned to ensure they are in a stable state of their disease (characterised by symptoms and having had no treatment changes for 28 days prior to the visit). All participants will continue with the timing and prescribed dosing of all inhaled medications as directed prior to the study. Subjects will be their own controls. Subjects will be randomly assigned to the order that they perform the study sessions. Visit A will involve a period of rest for up to 60 minutes in-between assessments; Visit B will involve a session of airway clearance (ACT) utilising the Active Cycle of Breathing Techniques (ACBT) supervised by a specialist physiotherapist in adult CF. The ACT session will last for thirty minutes minimum, to 60 minutes maximum until a consensus is reached between participant and physiotherapist that the participant's chest is clear.
Subjects will perform the OM tests of impulse oscillation system (IOS), lung clearance index (LCI), and spirometry, then either rest (visit A) or perform a supervised ACBT session (visit B) using electronic impedance tomography (EIT) during the session. IOS, LCI and spirometry will be repeated immediately after the session. Sputum will be collected throughout the ACT or rest sessions and for 30 minutes after each of these sessions is completed. Questionnaires asking patient views on the OMs will be given for completion after the last OM test is completed on each study visit.
There are no planned follow up measurements for participants in this study design.
All usual medications will be permitted for this study. Attention will be paid to mucoactive drugs (Pulmozyme®, Mannitol®, Hypertonic saline) to ensure the same frequency and dosing of inhalations for both study visits.
Data will be analysed in 3 groups based upon disease severity. Analysis will be based upon differences in outcome measures and in-between study days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Visit A | Active comparator | Other: Rest periodRest period for 30-60 minutes |
| Visit B | Active comparator | Procedure: Airway clearance session using the Active Cycle of Breathing Techniques (ACBT)Airway clearance session utilising the Active Cycle of Breathing techniques (ACBT) supervised by a specialist physiotherapist for 30-60 minutes. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of CF (confirmed by standard criteria)
- Sixteen years of age or over
- Patients in a stable state (characterised by no required therapy changes within 28 days of visit and patient symptoms)
Key exclusion criteria (9 listed)
- Current infective exacerbation or reduction in lung function requiring therapeutic intervention
- Current moderate haemoptysis (greater than streaking in the sputum)
- Current dependency on positive pressure support with ACT
- Previous history of spontaneous rib fractures
- Pregnancy
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 |
|---|---|---|
| Airway clearance session using the Active Cycle of Breathing Techniques (ACBT)An airway clearance technique incorporating thoracic expansion exercises, breathing control (normal diaphragmatic breathing) and the forced expiration technique (or huffing) | Procedure or surgery | Visit B |
| Rest periodA 30-60 minute of resting | Other | Visit A |
Primary outcome
Change in Lung Clearance Index
Time frame: Immediately pre-intervention and immediately post-intervention
This is a technique which involves breathing quietly through a tube whilst wearing nose clips. The test measures harmless tracer gases which are breathed in and out and measured by a sensitive gas-detection system. The LCI is calculated based on how long it takes for the gas to be breathed out from the lungs, and it shows if there are areas within the lung that are working less efficiently than others, for example when areas of the lung are clogged with mucus.
Change in Forced Expiratory Volume in One Second
Time frame: Immediately pre-intervention and immediately post-intervention
A forced expiratory manoeuvre into a spirometer (value derived from 1 second blow)
Electronic Impedance Tomography
Time frame: During intervention
This technique involves wearing a belt around the chest which has electrodes attached to it. Undetectable alternating electrical currents are then applied to the electrodes, which the participant will not be able to feel. The machine measures how easy or difficult it is for that current to travel through the lungs and any differences are calculated, giving a picture of the ventilation of the lung.
Change in Impulse Oscillation System
Time frame: Immediately pre-intervention and immediately post-intervention
The Impulse Oscillation system is a non-invasive technique where the participant breathes normally through a mouthpiece whilst wearing a nose clip, into a machine which produces small pressure vibrations (oscillations). The machine measures these vibrations and any changes to them to give an idea of obstructions to the airways, for example any mucus clogging.
Sputum Wet Weight
Time frame: During intervention and for 30 minutes post-intervention
Amount of sputum expectorated will be measured in a pre-weighed pot
6 secondary outcomes
Change in Forced Vital Capacity
Time frame: Immediately pre-intervention and immediately post-intervention
Change in Forced Expiratory Flow at 25% of Forced Vital Capacity
Time frame: Immediately pre-intervention and immediately post-intervention
Change in Forced Expiratory Flow at 50% of Forced Vital Capacity
Time frame: Immediately pre-intervention and immediately post-intervention
Change in Forced Expiratory Flow at 75% of Forced Vital Capacity
Time frame: Immediately pre-intervention and immediately post-intervention
Oxygen saturation measurements
Time frame: During interventions
Patient feedback questionnaire
Time frame: Straight after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Background: PubMed 24315208Kent L, Reix P, Innes JA, Zielen S, Le Bourgeois M, Braggion C, Lever S, Arets HG, Brownlee K, Bradley JM, Bayfield K, O'Neill K, Savi D, Bilton D, Lindblad A, Davies JC, Sermet I, De Boeck K; European Cystic Fibrosis Society Clinical Trial Network (ECFS-CTN) Standardisation Committee. Lung clearance index: evidence for use in clinical trials in cystic fibrosis. J Cyst Fibros. 2014 Mar;13(2):123-38. doi: 10.1016/j.jcf.2013.09.005. Epub 2013 Dec 5.
- Background: PubMed 16412951Bradley JM, Moran FM, Elborn JS. Evidence for physical therapies (airway clearance and physical training) in cystic fibrosis: an overview of five Cochrane systematic reviews. Respir Med. 2006 Feb;100(2):191-201. doi: 10.1016/j.rmed.2005.11.028.
- Background: PubMed 19703826Osman LP, Roughton M, Hodson ME, Pryor JA. Short-term comparative study of high frequency chest wall oscillation and European airway clearance techniques in patients with cystic fibrosis. Thorax. 2010 Mar;65(3):196-200. doi: 10.1136/thx.2008.111492. Epub 2009 Aug 23.
- Background: PubMed 25612899Pfleger A, Steinbacher M, Schwantzer G, Weinhandl E, Wagner M, Eber E. Short-term effects of physiotherapy on ventilation inhomogeneity in cystic fibrosis patients with a wide range of lung disease severity. J Cyst Fibros. 2015 Sep;14(5):627-31. doi: 10.1016/j.jcf.2014.12.017. Epub 2015 Jan 19.
- Background: PubMed 25222606Wettstein M, Radlinger L, Riedel T. Effect of different breathing aids on ventilation distribution in adults with cystic fibrosis. PLoS One. 2014 Sep 15;9(9):e106591. doi: 10.1371/journal.pone.0106591. eCollection 2014.
- BackgroundHorsley A. 2009. 'Non-Invasive Assessment of Ventilation Maldistribution in Lung Disease Using Multiple Breath Inert Gas Washouts', University of Edinburgh, UK
- BackgroundHurt, K. 2013. 'Small Airways Assessment In Adult Cystic Fibrosis', Imperial College (National Heart and Lung Institute), UK
- Derived from this study: PubMed 33020113Stanford G, Davies JC, Usmani O, Banya W, Charman S, Jones M, Simmonds NJ, Bilton D. Investigating outcome measures for assessing airway clearance techniques in adults with cystic fibrosis: protocol of a single-centre randomised controlled crossover trial. BMJ Open Respir Res. 2020 Oct;7(1):e000694. doi: 10.1136/bmjresp-2020-000694.
- Individual participant dataSharing planned: No
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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.
Nicholas J Simmonds, MD(Res) FRCP principal investigator
The Royal Brompton & Harefield NHS Foundation Trust and Imperial College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airway clearance session using the Active Cycle of Breathing Techniques (ACBT) and Rest period in people with Cystic Fibrosis, run by Royal Brompton & Harefield NHS Foundation Trust 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 15 Dec 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Lung Clearance Index (time frame: Immediately pre-intervention and immediately post-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02721498, which also lists 8 linked publications.
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 15 Dec 2021.