Cystic FibrosisNCT01753869
Timing of Hypertonic Saline Inhalation Relative to Airways Clearance in Cystic Fibrosis
A study testing Airways clearance and Hypertonic saline inhalation in people with Cystic Fibrosis, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
Trial summary
Lung disease is the predominant cause of morbidity and mortality in Cystic Fibrosis (CF) with 80% of deaths resulting directly or indirectly from pulmonary disease. Abnormal airway clearance causes retention of mucus resulting in frequent chest infections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Airways clearance and Hypertonic saline inhalation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2012to Jun 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients with a documented diagnosis of CF aged ≥18 years.
- Written informed consent.
- At least day 10 - 14 of IV antibiotic therapy during a hospital admission for a pulmonary exacerbation.
- Patients must be able to perform acceptable spirometric manoeuvres, according to the American Thoracic Society/ERS (ATS/ERS) standards (Miller, Hankinson et. al. 2005).
- Patient with an FEV1% predicted of ≥ 40%predicted (Stanojevic, Wade et al. 2008).
- Patients who are productive of sputum from screening visit to study visit 1 (≥10g over 24 hours).
- Patients who have been prescribed HTS (Nebusal 7%) and have successfully completed a challenge test.
- Any other chronic medication must have commenced therapy 4 weeks prior to screening and be willing to continue this therapy for the entire duration of the study.
Who cannot join
- Day 1-9 of IV antibiotic therapy during a hospital admission.
- Patients who are colonized with Burkholderia cepacia complex.
- Patient who are HTS naive.
- Patients who have an intolerance to HTS.
- Patients who are currently participating in another study or have participated in another study with an investigational drug within one month of screening.
- Clinically significant disease or medical condition other than CF or CF-related conditions that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data.
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Belfast Health and Social Care Trust, Belfast City Hospital
Belfast, BT9 7JL
About this study
Lung disease is the predominant cause of morbidity and mortality in Cystic Fibrosis (CF) with 80% of deaths resulting directly or indirectly from pulmonary disease. Abnormal airway clearance causes retention of mucus resulting in frequent chest infections. Physiotherapists use different techniques to help clear mucus from the lungs of patients with CF. Inhaled medications and airways clearance techniques (ACTs) are central to a CF patient's daily treatment and are often coordinated.
Burden of treatment is a common reason for non-adherence in this patient group, and streamlining of treatment timings is sought to optimize adherence whilst ensuring efficacy to an often complex daily regimen of inhaled bronchodilators, nebulizers and ACTs. A gap in the research exists as to the optimal timing of Hypertonic Saline (HTS) and ACT within the daily regimen. A study to show whether the timing of HTS around ACT is significant, can better inform patients and potentially allow more flexibility around their treatment regimen.
Read more
Lung Clearance Index (LCI) has shown good sensitivity to abnormalities in lung function compared with spirometry and has demonstrated a treatment effect in other trials. LCI may be a suitable tool therefore, to assess intervention strategies aimed at airways clearance in CF. This study aims to compare the effects ACTs after HTS inhalation versus ACTs during HTS inhalation as measured by LCI.
It is a randomized, crossover trial of ACTs after HTS inhalation compared with ACTs during HTS inhalation in adult CF patients during day 10-14 of a hospital admission for treatment of a pulmonary exacerbation. Patients will be randomized to receive 1 of the treatment session options on the first day and the reverse on the second day.
The primary objective of this study is to compare the change in LCI (a measure of lung function) at 90 minutes post treatment with ACTs after HTS inhalation compared with ACTs during HTS inhalation in adult CF patients.
LCI (lung clearance index) ACT (airway clearance technique) HTS (hypertonic saline)
- Conditions
- Cystic Fibrosis
- Being tested
- Airways clearance and Hypertonic saline inhalation
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airways clearance and Hypertonic saline inhalationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| ACTs after HTS inhalation: | Active comparator | ACTs after HTS inhalation: Patients will take a bronchodilator (Salbutamol, 2 puffs) wait 15 minutes, and then take a single inhalation (4 mls) of 7% HTS (Nebusal™) via updraft nebulizer (Portex) (approximately 20 minutes) immediately followed by an airways clearance session of 10 supervised cycles of Active Cycle of Breathing Technique (ACBT) using the acapella® (approximately 20 minutes). Receives: Procedure: Airways clearance and Hypertonic saline inhalation |
| ACTs during HTS inhalation | Active comparator | ACTs during HTS inhalation: Patients take a bronchodilator (Salbutamol, 2 puffs), wait 15 minutes, and then take a single inhalation (4mls) of 7% HTS (Nebusal™) through the acapella® duet (with portex updraft nebulizer attached) device. During inhalation, an airways clearance session of 10 supervised cycles of ACBT using the acapella® will be carried out (approximately 20 minutes). Receives: Procedure: Airways clearance and Hypertonic saline inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Clearance Index
Measured: 90 minutes post treatment
Secondary outcomes (1)
24 hour sputum volume
Measured: 24 hours post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: Challenges with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University, Belfast, University of Ulster
- Responsible party
- Principal investigator, Katherine O'Neill, Queen's University, Belfast
- Investigators
- Judy M Bradley, PhD, Principal investigator, University of Ulster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753869
- Sponsor's protocol ID
- 12025JB-AS
- Status last verified
- Jul 2016
- First submitted
- 13 Dec 2012
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Morrison L, Milroy S. Oscillating devices for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev. 2020 Apr 30;4(4):CD006842. doi: 10.1002/14651858.CD006842.pub5.
PubMed 32352564O'Neill K, Moran F, Tunney MM, Elborn JS, Bradbury I, Downey DG, Rendall J, Bradley JM. Timing of hypertonic saline and airway clearance techniques in adults with cystic fibrosis during pulmonary exacerbation: pilot data from a randomised crossover study. BMJ Open Respir Res. 2017 Jan 12;4(1):e000168. doi: 10.1136/bmjresp-2016-000168. eCollection 2017.
PubMed 28123751
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Hypertonic Saline Inhalation Relative to Airways Clearance in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01753869
- Acronym / sponsor ID
- 12025JB-AS
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Challenges with recruitment
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Collaborators
- Queen's University, Belfast, University of Ulster
- Study start
- Dec 2012
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Dec 2012 (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.
Lung disease is the predominant cause of morbidity and mortality in Cystic Fibrosis (CF) with 80% of deaths resulting directly or indirectly from pulmonary disease. Abnormal airway clearance causes retention of mucus resulting in frequent chest infections. Physiotherapists use different techniques to help clear mucus from the lungs of patients with CF. Inhaled medications and airways clearance techniques (ACTs) are central to a CF patient's daily treatment and are often coordinated.
Burden of treatment is a common reason for non-adherence in this patient group, and streamlining of treatment timings is sought to optimize adherence whilst ensuring efficacy to an often complex daily regimen of inhaled bronchodilators, nebulizers and ACTs. A gap in the research exists as to the optimal timing of Hypertonic Saline (HTS) and ACT within the daily regimen. A study to show whether the timing of HTS around ACT is significant, can better inform patients and potentially allow more flexibility around their treatment regimen.
Lung Clearance Index (LCI) has shown good sensitivity to abnormalities in lung function compared with spirometry and has demonstrated a treatment effect in other trials. LCI may be a suitable tool therefore, to assess intervention strategies aimed at airways clearance in CF. This study aims to compare the effects ACTs after HTS inhalation versus ACTs during HTS inhalation as measured by LCI.
It is a randomized, crossover trial of ACTs after HTS inhalation compared with ACTs during HTS inhalation in adult CF patients during day 10-14 of a hospital admission for treatment of a pulmonary exacerbation. Patients will be randomized to receive 1 of the treatment session options on the first day and the reverse on the second day.
The primary objective of this study is to compare the change in LCI (a measure of lung function) at 90 minutes post treatment with ACTs after HTS inhalation compared with ACTs during HTS inhalation in adult CF patients.
LCI (lung clearance index) ACT (airway clearance technique) HTS (hypertonic saline)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACTs after HTS inhalation: | Active comparator | Procedure: Airways clearance and Hypertonic saline inhalationACTs after HTS inhalation: Patients will take a bronchodilator (Salbutamol, 2 puffs) wait 15 minutes, and then take a single inhalation (4 mls) of 7% HTS (Nebusal™) via updraft nebulizer (Portex) (approximately 20 minutes) immediately followed by an airways clearance session of 10 supervised cycles of Active Cycle of Breathing Technique (ACBT) using the acapella® (approximately 20 minutes). |
| ACTs during HTS inhalation | Active comparator | Procedure: Airways clearance and Hypertonic saline inhalationACTs during HTS inhalation: Patients take a bronchodilator (Salbutamol, 2 puffs), wait 15 minutes, and then take a single inhalation (4mls) of 7% HTS (Nebusal™) through the acapella® duet (with portex updraft nebulizer attached) device. During inhalation, an airways clearance session of 10 supervised cycles of ACBT using the acapella® will be carried out (approximately 20 minutes). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients with a documented diagnosis of CF aged ≥18 years.
- Written informed consent.
- At least day 10 - 14 of IV antibiotic therapy during a hospital admission for a pulmonary exacerbation.
- Patients must be able to perform acceptable spirometric manoeuvres, according to the American Thoracic Society/ERS (ATS/ERS) standards (Miller, Hankinson et. al. 2005).
- Patient with an FEV1% predicted of ≥ 40%predicted (Stanojevic, Wade et al. 2008).
Key exclusion criteria (7 listed)
- Day 1-9 of IV antibiotic therapy during a hospital admission.
- Patients who are colonized with Burkholderia cepacia complex.
- Patient who are HTS naive.
- Patients who have an intolerance to HTS.
- Patients who are currently participating in another study or have participated in another study with an investigational drug within one month of screening.
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 |
|---|---|---|
| Airways clearance and Hypertonic saline inhalation | Procedure or surgery | ACTs after HTS inhalation:, ACTs during HTS inhalation |
Primary outcome
Lung Clearance Index
Time frame: 90 minutes post treatment
1 secondary outcome
24 hour sputum volume
Time frame: 24 hours post treatment
Results and safety
The study was stopped early (reason given: Challenges with recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
- Derived from this study: PubMed 32352564Morrison L, Milroy S. Oscillating devices for airway clearance in people with cystic fibrosis. Cochrane Database Syst Rev. 2020 Apr 30;4(4):CD006842. doi: 10.1002/14651858.CD006842.pub5.
- Derived from this study: PubMed 28123751O'Neill K, Moran F, Tunney MM, Elborn JS, Bradbury I, Downey DG, Rendall J, Bradley JM. Timing of hypertonic saline and airway clearance techniques in adults with cystic fibrosis during pulmonary exacerbation: pilot data from a randomised crossover study. BMJ Open Respir Res. 2017 Jan 12;4(1):e000168. doi: 10.1136/bmjresp-2016-000168. eCollection 2017.
- 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.
Judy M Bradley, PhD principal investigator
University of Ulster
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airways clearance and Hypertonic saline inhalation in people with Cystic Fibrosis, run by Belfast Health and Social Care 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 8 inclusion and 7 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 19 Jul 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. 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: Challenges with recruitment). 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?
Lung Clearance Index (time frame: 90 minutes post treatment). 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 NCT01753869, which also lists 2 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 19 Jul 2016.