Cystic FibrosisNIVNCT01885650
The Addition of Non-Invasive Ventilation To Airway Clearance Techniques In Adults With Cystic Fibrosis
A study testing Airway Clearance Techniques in people with Cystic Fibrosis, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Cystic Fibrosis (CF) is a genetic disorder of altered ion transport across cell membranes which is characterised by the production of thickened bodily secretions, affecting the function of organs such as the pancreas and the lungs. 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 Techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2013to 11 May 2017
- 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 cystic fibrosis (confirmed by genotype or a sweat sodium concentration of >70mmol/l or sweat chloride of >60mmol/l)
- Sixteen years of age or over
- Patients admitted to the Royal Brompton Hospital with a pulmonary exacerbation of which is resolving. Patients will be considered for inclusion from day 7 of treatment to 3 days prior to discharge (as determined by a member of the cystic fibrosis medical team and have spirometric values within 20% of the mean of the last two stable recordings (at least 1 month apart)
- Patients with an established airway clearance regime that they have used for 3 months or more
Who cannot join
- Current moderate haemoptysis (greater than streaking in the sputum)
- Current pneumothorax or history of pneumothorax in the 3 months prior to consideration for the study
- Current dependency on positive pressure support with airway clearance via the IPPB (Intermittent Positive Pressure Breathing) machine or NIV
- Previous history of spontaneous rib fractures
- Pregnancy
- Inability to give consent for treatment or measurement
- Current participation in another study
- If the patient requires more than 2 airway clearance sessions a day
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: Non-Invasive Ventilation (NIV) For Positive Pressure Support. A Randomised Cross-Over Trial To Evaluate The Short-Term Effects of NIV As An Adjunct To Airway Clearance Techniques in Adults With Cystic Fibrosis.
Cystic Fibrosis (CF) is a genetic disorder of altered ion transport across cell membranes which is characterised by the production of thickened bodily secretions, affecting the function of organs such as the pancreas and the lungs. Within the lungs, thickened sputum is very difficult to clear, which can results in recurrent chest infections, which can lead to lung damage. therefore it is important to optimise the removal of sputum to try and prevent these complications. Traditionally, a variety of approaches are usually combined including inhaled medications to thin or hydrate secretions, and chest physiotherapy to mobilise secretions and improve sputum clearance.
There are many chest physiotherapy or airway clearance techniques (ACT) available including breathing methods such as the Active Cycle of Breathing Techniques (ACBT) or Autogenic Drainage (AD) and adjuncts such as Positive Expiratory Pressure (PEP), High Frequency Chest Oscillation (the "Vest"), or oscillatory devices such as the Flutter or Acapella. When people with CF have an infection or have severe disease often the effectiveness of ACTs can decrease due to fatigue, shortness of breath or having an overwhelming amount of sputum. At this time it is necessary to re-assess ACTs and the addition of positive pressure to airway clearance techniques has been shown to be helpful in decreasing fatigue during chest physiotherapy.
Read more
At present no research studies have reported an increase in sputum cleared with the addition of positive pressure, however it is thought that the ability to take a deeper breath when using positive pressure would help to improve sputum clearance. With clinical experience of the use of NIV with adult CF patients, the investigators aim to explore this objectively in this study.
Research Question:
Does the addition of non-invasive ventilation (Breas, I-Sleep 25) as supplementary positive pressure to normal airway clearance techniques improve sputum clearance in stable adult patients with cystic fibrosis?
Hypothesis
The inclusion of non-invasive ventilation in addition to a patient's normal airway clearance technique will lead to improvements in subjective ease of clearance and work of breathing during airway clearance and objectively increase sputum clearance, as well as being well tolerated in patients as an adjunct to airway clearance.
Read the detailed description
Cystic Fibrosis (CF) is a genetic disorder of altered ion transport across cell membranes which is characterised by the production of thickened bodily secretions, affecting the function of organs such as the pancreas and the lungs. Within the lungs, thickened mucus alters normal mucocillary clearance mechanisms resulting in airway obstruction, mucus plugging and recurrent infections. The cycle of recurrent infections and subsequent inflammation is thought to be the major mechanism towards damage to lung tissue and the occurrence of fibrosis, which decreases lung function, lowers tissue oxygenation and eventually leads to respiratory failure and death. Optimisation of the removal of airway secretions is therefore an integral part of the management of CF in order to try and prevent these complications. Traditionally, a variety of approaches are usually combined including mucolytic or hydrator therapy to make the secretions less viscous, and chest physiotherapy to mobilise secretions and improve airway clearance.
There are many chest physiotherapy or airway clearance techniques (ACT) available including breathing methods such as the Active Cycle of Breathing Techniques (ACBT) or Autogenic Drainage (AD) and adjuncts such as Positive Expiratory Pressure (PEP), High Frequency Chest Oscillation (the "Vest"), or oscillatory devices such as the Flutter or Acapella. Research has shown there to be no difference in effectiveness between techniques, as long as they are performed correctly and regularly, and therefore choice of ACT depends upon assessment of the patient by a trained physiotherapist and discussions with the individual. With advancing disease or infections, often the effectiveness of ACTs can decrease due to patient fatigue, shortness of breath or overwhelming amount of secretions. At this time it is necessary to re-assess ACTs, and the addition of positive pressure to airway clearance techniques has been shown to decrease patient fatigue and respiratory rates during clearance. One of these studies also demonstrated improvements in oxygenation and respiratory muscle strength after the use of positive pressure with ACT. While no studies have reported an increase in sputum expectorated with the addition of positive pressure, the ability to augment greater tidal volumes through positive pressure is thought to be a mechanism which could improve sputum clearance. Clinical experience at the Royal Brompton hospital has indicated that with alterations in pressure and flow rates from resting settings, sputum clearance appears to be easier and more effective; the investigators aim to explore this observation objectively in this study.
Research Question:
Does the addition of non-invasive ventilation (Breas, I-Sleep 25) as supplementary positive pressure to normal airway clearance techniques improve sputum clearance in stable adult patients with cystic fibrosis?
Hypothesis
The inclusion of non-invasive ventilation in addition to a patient's normal airway clearance technique will lead to improvements in subjective ease of clearance and work of breathing during airway clearance and objectively increase sputum clearance, as well as being well tolerated in patients as an adjunct to airway clearance.
- Conditions
- Cystic Fibrosis
- Being tested
- Airway Clearance Techniques
- Keywords
- Non invasive ventilation, Chest physiotherapy, Airway clearance
- 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 TechniquesOther
| Study group | Role | What they receive |
|---|---|---|
| Normal airway clearance | Experimental | The patients usual airway clearance technique Receives: Other: Airway Clearance Techniques |
| Non-Invasive Ventilation | Experimental | The addition of positive pressure via a non-invasive ventilator to the participants usual airway clearance technique Receives: Other: Airway Clearance Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sputum weight (wet) expectorated during, up to 30 minutes after treatment and the 24 hour total weight
The amount of sputum expectorated by the patient both up to 30 minutes after treatment, and the total amount cleared in 24 hours after each treatment
Measured: 24 hours
Secondary outcomes (3)
Qualitative assessment using 10 centimetre Visual Analogue Scale (VAS) of ease of clearance, work of breathing during clearance and satisfaction of each treatment approach (A or B).
Measured: Within 5 minutes immediately after each treatment
Lung function tests
Forced Expiratory Volume in 1 second (FEV1) Forced Vital Capacity (FVC) Forced Expiratory Flow at 25% of FVC (FEF25) Forced Expiratory Flow at 75% of FVC (FEF75)
Measured: 5 minutes before treatment, within 5 minutes immediately after treatment and 30 minutes after treatment
Oxygen saturations during the treatment session
Measurements of oxygen saturations via finger probe pulse oximetry
Measured: During the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startJul 2013
- Primary completion11 May 2017
- Study completion11 May 2017
Why it stopped: Based upon results of interim data analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gemma Stanford, BSc (Hons) Physiotherapy, Principal investigator, The Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885650
- Sponsor's protocol ID
- 13/LO/0565
- Acronym
- NIV
- Status last verified
- Aug 2017
- First submitted
- 17 Jun 2013
- Last updated
- 2 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cantin A. Cystic fibrosis lung inflammation: early, sustained, and severe. Am J Respir Crit Care Med. 1995 Apr;151(4):939-41. doi: 10.1164/ajrccm.151.4.7697269. No abstract available.
PubMed 7697269Fauroux B, Boule M, Lofaso F, Zerah F, Clement A, Harf A, Isabey D. Chest physiotherapy in cystic fibrosis: improved tolerance with nasal pressure support ventilation. Pediatrics. 1999 Mar;103(3):E32. doi: 10.1542/peds.103.3.e32.
PubMed 10049988Holland AE, Denehy L, Ntoumenopoulos G, Naughton MT, Wilson JW. Non-invasive ventilation assists chest physiotherapy in adults with acute exacerbations of cystic fibrosis. Thorax. 2003 Oct;58(10):880-4. doi: 10.1136/thorax.58.10.880.
PubMed 14514944Konstan MW, Berger M. Current understanding of the inflammatory process in cystic fibrosis: onset and etiology. Pediatr Pulmonol. 1997 Aug;24(2):137-42; discussion 159-61. doi: 10.1002/(sici)1099-0496(199708)24:23.0.co;2-3.
PubMed 9292910Osman 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 19703826Placidi G, Cornacchia M, Polese G, Zanolla L, Assael BM, Braggion C. Chest physiotherapy with positive airway pressure: a pilot study of short-term effects on sputum clearance in patients with cystic fibrosis and severe airway obstruction. Respir Care. 2006 Oct;51(10):1145-53.
PubMed 17005060Pryor JA, Tannenbaum E, Scott SF, Burgess J, Cramer D, Gyi K, Hodson ME. Beyond postural drainage and percussion: Airway clearance in people with cystic fibrosis. J Cyst Fibros. 2010 May;9(3):187-92. doi: 10.1016/j.jcf.2010.01.004. Epub 2010 Feb 12.
PubMed 20153269Zach MS. Lung disease in cystic fibrosis--an updated concept. Pediatr Pulmonol. 1990;8(3):188-202. doi: 10.1002/ppul.1950080311. No abstract available.
PubMed 2190148Stanford G, Parrott H, Bilton D, Agent P, Banya W, Simmonds N. Randomised cross-over trial evaluating the short-term effects of non-invasive ventilation as an adjunct to airway clearance techniques in adults with cystic fibrosis. BMJ Open Respir Res. 2019 Apr 14;6(1):e000399. doi: 10.1136/bmjresp-2018-000399. eCollection 2019.
PubMed 31179002
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Ventilation (NIV) For Positive Pressure Support. A Randomised Cross-Over Trial To Evaluate The Short-Term Effects of NIV As An Adjunct To Airway Clearance Techniques in Adults With Cystic Fibrosis.
- ClinicalTrials.gov ID
- NCT01885650
- Acronym / sponsor ID
- NIV / 13/LO/0565
- Conditions
- Cystic Fibrosis
- Keywords
- Non invasive ventilation, Chest physiotherapy, Airway clearance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based upon results of interim data analysis
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- 11 May 2017 (actual)
- Study completion
- 11 May 2017 (actual)
- First posted
- 25 Jun 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.
Cystic Fibrosis (CF) is a genetic disorder of altered ion transport across cell membranes which is characterised by the production of thickened bodily secretions, affecting the function of organs such as the pancreas and the lungs. Within the lungs, thickened sputum is very difficult to clear, which can results in recurrent chest infections, which can lead to lung damage. therefore it is important to optimise the removal of sputum to try and prevent these complications. Traditionally, a variety of approaches are usually combined including inhaled medications to thin or hydrate secretions, and chest physiotherapy to mobilise secretions and improve sputum clearance.
There are many chest physiotherapy or airway clearance techniques (ACT) available including breathing methods such as the Active Cycle of Breathing Techniques (ACBT) or Autogenic Drainage (AD) and adjuncts such as Positive Expiratory Pressure (PEP), High Frequency Chest Oscillation (the "Vest"), or oscillatory devices such as the Flutter or Acapella. When people with CF have an infection or have severe disease often the effectiveness of ACTs can decrease due to fatigue, shortness of breath or having an overwhelming amount of sputum. At this time it is necessary to re-assess ACTs and the addition of positive pressure to airway clearance techniques has been shown to be helpful in decreasing fatigue during chest physiotherapy.
At present no research studies have reported an increase in sputum cleared with the addition of positive pressure, however it is thought that the ability to take a deeper breath when using positive pressure would help to improve sputum clearance. With clinical experience of the use of NIV with adult CF patients, the investigators aim to explore this objectively in this study.
Research Question:
Does the addition of non-invasive ventilation (Breas, I-Sleep 25) as supplementary positive pressure to normal airway clearance techniques improve sputum clearance in stable adult patients with cystic fibrosis?
Hypothesis
The inclusion of non-invasive ventilation in addition to a patient's normal airway clearance technique will lead to improvements in subjective ease of clearance and work of breathing during airway clearance and objectively increase sputum clearance, as well as being well tolerated in patients as an adjunct to airway clearance.
Detailed description
Cystic Fibrosis (CF) is a genetic disorder of altered ion transport across cell membranes which is characterised by the production of thickened bodily secretions, affecting the function of organs such as the pancreas and the lungs. Within the lungs, thickened mucus alters normal mucocillary clearance mechanisms resulting in airway obstruction, mucus plugging and recurrent infections. The cycle of recurrent infections and subsequent inflammation is thought to be the major mechanism towards damage to lung tissue and the occurrence of fibrosis, which decreases lung function, lowers tissue oxygenation and eventually leads to respiratory failure and death. Optimisation of the removal of airway secretions is therefore an integral part of the management of CF in order to try and prevent these complications. Traditionally, a variety of approaches are usually combined including mucolytic or hydrator therapy to make the secretions less viscous, and chest physiotherapy to mobilise secretions and improve airway clearance.
There are many chest physiotherapy or airway clearance techniques (ACT) available including breathing methods such as the Active Cycle of Breathing Techniques (ACBT) or Autogenic Drainage (AD) and adjuncts such as Positive Expiratory Pressure (PEP), High Frequency Chest Oscillation (the "Vest"), or oscillatory devices such as the Flutter or Acapella. Research has shown there to be no difference in effectiveness between techniques, as long as they are performed correctly and regularly, and therefore choice of ACT depends upon assessment of the patient by a trained physiotherapist and discussions with the individual. With advancing disease or infections, often the effectiveness of ACTs can decrease due to patient fatigue, shortness of breath or overwhelming amount of secretions. At this time it is necessary to re-assess ACTs, and the addition of positive pressure to airway clearance techniques has been shown to decrease patient fatigue and respiratory rates during clearance. One of these studies also demonstrated improvements in oxygenation and respiratory muscle strength after the use of positive pressure with ACT. While no studies have reported an increase in sputum expectorated with the addition of positive pressure, the ability to augment greater tidal volumes through positive pressure is thought to be a mechanism which could improve sputum clearance. Clinical experience at the Royal Brompton hospital has indicated that with alterations in pressure and flow rates from resting settings, sputum clearance appears to be easier and more effective; the investigators aim to explore this observation objectively in this study.
Research Question:
Does the addition of non-invasive ventilation (Breas, I-Sleep 25) as supplementary positive pressure to normal airway clearance techniques improve sputum clearance in stable adult patients with cystic fibrosis?
Hypothesis
The inclusion of non-invasive ventilation in addition to a patient's normal airway clearance technique will lead to improvements in subjective ease of clearance and work of breathing during airway clearance and objectively increase sputum clearance, as well as being well tolerated in patients as an adjunct to airway clearance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal airway clearance | Experimental | Other: Airway Clearance TechniquesThe patients usual airway clearance technique |
| Non-Invasive Ventilation | Experimental | Other: Airway Clearance TechniquesThe addition of positive pressure via a non-invasive ventilator to the participants usual airway clearance technique |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of cystic fibrosis (confirmed by genotype or a sweat sodium concentration of >70mmol/l or sweat chloride of >60mmol/l)
- Sixteen years of age or over
- Patients admitted to the Royal Brompton Hospital with a pulmonary exacerbation of which is resolving. Patients will be considered for inclusion from day 7 of treatment to 3 days prior to discharge (as determined by a member of the cystic fibrosis medical team and have spirometric values within 20% of the mean of the last two stable recordings (at least 1 month apart)
- Patients with an established airway clearance regime that they have used for 3 months or more
Key exclusion criteria (8 listed)
- Current moderate haemoptysis (greater than streaking in the sputum)
- Current pneumothorax or history of pneumothorax in the 3 months prior to consideration for the study
- Current dependency on positive pressure support with airway clearance via the IPPB (Intermittent Positive Pressure Breathing) machine or NIV
- 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 Techniques | Other | Non-Invasive Ventilation, Normal airway clearance |
Primary outcome
Sputum weight (wet) expectorated during, up to 30 minutes after treatment and the 24 hour total weight
Time frame: 24 hours
The amount of sputum expectorated by the patient both up to 30 minutes after treatment, and the total amount cleared in 24 hours after each treatment
3 secondary outcomes
Qualitative assessment using 10 centimetre Visual Analogue Scale (VAS) of ease of clearance, work of breathing during clearance and satisfaction of each treatment approach (A or B).
Time frame: Within 5 minutes immediately after each treatment
Lung function tests
Time frame: 5 minutes before treatment, within 5 minutes immediately after treatment and 30 minutes after treatment
Oxygen saturations during the treatment session
Time frame: During the treatment
Results and safety
The study was stopped early (reason given: Based upon results of interim data analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Background: PubMed 7697269Cantin A. Cystic fibrosis lung inflammation: early, sustained, and severe. Am J Respir Crit Care Med. 1995 Apr;151(4):939-41. doi: 10.1164/ajrccm.151.4.7697269. No abstract available.
- Background: PubMed 10049988Fauroux B, Boule M, Lofaso F, Zerah F, Clement A, Harf A, Isabey D. Chest physiotherapy in cystic fibrosis: improved tolerance with nasal pressure support ventilation. Pediatrics. 1999 Mar;103(3):E32. doi: 10.1542/peds.103.3.e32.
- Background: PubMed 14514944Holland AE, Denehy L, Ntoumenopoulos G, Naughton MT, Wilson JW. Non-invasive ventilation assists chest physiotherapy in adults with acute exacerbations of cystic fibrosis. Thorax. 2003 Oct;58(10):880-4. doi: 10.1136/thorax.58.10.880.
- Background: PubMed 9292910Konstan MW, Berger M. Current understanding of the inflammatory process in cystic fibrosis: onset and etiology. Pediatr Pulmonol. 1997 Aug;24(2):137-42; discussion 159-61. doi: 10.1002/(sici)1099-0496(199708)24:23.0.co;2-3.
- 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 17005060Placidi G, Cornacchia M, Polese G, Zanolla L, Assael BM, Braggion C. Chest physiotherapy with positive airway pressure: a pilot study of short-term effects on sputum clearance in patients with cystic fibrosis and severe airway obstruction. Respir Care. 2006 Oct;51(10):1145-53.
- Background: PubMed 20153269Pryor JA, Tannenbaum E, Scott SF, Burgess J, Cramer D, Gyi K, Hodson ME. Beyond postural drainage and percussion: Airway clearance in people with cystic fibrosis. J Cyst Fibros. 2010 May;9(3):187-92. doi: 10.1016/j.jcf.2010.01.004. Epub 2010 Feb 12.
- Background: PubMed 2190148Zach MS. Lung disease in cystic fibrosis--an updated concept. Pediatr Pulmonol. 1990;8(3):188-202. doi: 10.1002/ppul.1950080311. No abstract available.
- Derived from this study: PubMed 31179002Stanford G, Parrott H, Bilton D, Agent P, Banya W, Simmonds N. Randomised cross-over trial evaluating the short-term effects of non-invasive ventilation as an adjunct to airway clearance techniques in adults with cystic fibrosis. BMJ Open Respir Res. 2019 Apr 14;6(1):e000399. doi: 10.1136/bmjresp-2018-000399. eCollection 2019.
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
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.
Gemma Stanford, BSc (Hons) Physiotherapy principal investigator
The Royal Brompton & Harefield NHS Foundation Trust
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 Techniques 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 4 inclusion and 8 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 2 Aug 2017. 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 was stopped early (reason given: Based upon results of interim data analysis). 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?
Sputum weight (wet) expectorated during, up to 30 minutes after treatment and the 24 hour total weight (time frame: 24 hours). 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 NCT01885650, which also lists 9 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 2 Aug 2017.