Lung; Disease, Fibroid (Chronic)Phase 4AmbOxNCT02286063
Ambulatory Oxygen in Fibrotic Lung Disease (FLD) (AmbOx)
A Phase 4 study testing Ambulatory Oxygen in people with Lung; Disease, Fibroid (Chronic), run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The main aim of this project is to establish whether ambulatory oxygen in patients with fibrotic ILD whose oxygen saturation falls ≤ 88% on a 6MWT, leads to a significant improvement in health status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung; Disease, Fibroid (Chronic)
- What is being tested?
- Ambulatory Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to 31 Jan 2018
- Phase
- Phase 4
- 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
- IPF or another fibrotic ILD (including fibrotic NSIP, fibrotic organising pneumoni, and fibrotic hypersensitivity pneumonitis)
- patients aged 18 - 99 yrs
- Desaturation ≤ 88% on a 6MWT on room air
- Stable respiratory symptoms in the 4 weeks preceding the trial including the run in period
Who cannot join
- Patients meeting criteria for long term oxygen therapy, including hypercapnic patients
- Patients expected to change treatment during the course of the study
- Significant locomotor or communication difficulties and/or severe co-morbidities
- Patients with sarcoidosis or connective tissue disease affecting the musculoskeletal system
- Current smokers
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Controlled Crossover Trial to Evaluate the Effects of Ambulatory Oxygen on Health Status in Patients With Fibrotic Lung Disease (FLD).
The main aim of this project is to establish whether ambulatory oxygen in patients with fibrotic ILD whose oxygen saturation falls ≤ 88% on a 6MWT, leads to a significant improvement in health status. The core of the project will be a four week randomised, crossover controlled trial of ambulatory oxygen used during daily activities. The optimal Oxygen flow rate is determined by titration at screening visit and administered during activity for a two-week period, compared to two weeks off oxygen.
Read the detailed description
The planned non-commercial study is a randomised, controlled crossover trial of ambulatory oxygen against no ambulatory oxygen over a four week period (two weeks on ambulatory oxygen and two weeks on air, with no portable devices), to evaluate the effects of ambulatory oxygen on health status in patients with ILD. A short crossover study in this context has many advantages, since ambulatory oxygen has immediate effect, with no wash-out period needed after use. The primary outcome of the study will be the change in health status, as measured by the K-BILD questionnaire (Thorax 2012 67: 804-810).
At the start of the trial, the effects of ambulatory oxygen on 6 Minute Walk Test (6MWT) parameters will be evaluated on oxygen and on air-filled canisters, with the patient blind to the contents of the canister, to assess whether oxygen-induced improvements in 6MWT parameters can predict its effectiveness in day to day life. The 6MWT is a well established and highly reproducible test validated in ILD patients, with significant prognostic implications.
The study design does not include a placebo arm because:
- The intervention is a combination of possible benefits from oxygen and the disadvantage of canister weight. These cannot be separated. Placebo control is impossible because there is no means of providing placebo weight. Attempts to control solely for oxygen use without taking canister weight into account are clinically meaningless. In a recent COPD, chronic obstructive pulmonary disease study, cylinder weight was reported as a barrier to use by 93% of study participants.
- A positive result against an air-filled canister arm would be clinically uninterpretable. This is a study design in which the 'placebo' would be actively harmful to study participants. Carriage of an air-filled cylinder would be expected to lead to earlier desaturation and reduced exercise tolerance. Such a design would not inform the real life comparison between oxygen plus cylinder and no intervention.
- All this aside, blinding is legally impossible (UK health and safety regulations require that oxygen cylinders for home use must be clearly labelled).
It should also be stressed that objective measures of change are evaluated as secondary end-points: the investigators expect to explore correlations between these variables and the primary end-point to exclude the possibility that an observed treatment benefit on the primary end-point might be confounded by a placebo effect.
A more in depth qualitative assessment of the impact of ambulatory oxygen will be undertaken via a semi-structured interview, in a subset of 20 patients, to investigate patients' and their carers' personal perspective on how the ambulatory oxygen has affected their day to day life. The interview will be conducted within 2 weeks of the end of treatment visit. Patients from the Royal Brompton Hospital site will be approached by the researcher at the end of treatment visit and asked if they will participate in the qualitative assessment. If the patient agrees a date will be agreed for the patient to be interviewed at a venue convenient to them (usually the patient's home).
During the interviews a semi-structured topic guide will address practical barriers to optimal oxygen usage, practical, social and psychological difficulties encountered, concerned about dependency, and views on the information required prior to ambulatory oxygen prescription. The interviews will also explore patients' (and carers') experience of participating in the trial. Notes will be written after each interview to aid reflective analytical processes. Individual feed back on how the system and the service could be improved will assess how the needs of patients and their future involvement can be incorporated into the design of more patients and their future involvement can be incorporated into the design of more patients centred devices.
Qualitative interview analysis: Interviews will be transcribed verbatim. Interview transcripts will be analysed thematically using a framework approach. Atlas/ti computer software (http://atlasti.com) will be used to manage and index the data prior to charting, mapping and interpretation.
- Conditions
- Lung; Disease, Fibroid (Chronic)
- Being tested
- Ambulatory Oxygen
- Medical subject headings
- Disease, Leiomyoma, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory OxygenDrug
Also called portable oxygen cylinders, light weight oxygen cylinders
The IMP investigated in this study is medical oxygen (PL 15929/005), manufactured by Air Liquide Ltd. UK. Oxygen is a colourless, odourless gas with molecular weight 32, a boiling point of 183.1°C (at 1 bar) and a density of 1.355 kg/m3 (at 15°C and 1013mb).
Oxygen is present in the atmosphere at 21% and is an absolute necessity for life. Each of the four oxygen companies across the UK provide a light and a standard weight oxygen cylinder. Ambulatory Oxygen will be given to the Oxygen arm.
| Study group | Role | What they receive |
|---|---|---|
| ambulatory oxygen cylinders | Active comparator | Subjects randomised to have the intervention of portable oxygen for the first two weeks. Only patients with stable symptoms at the end of the 'run in' period and reproducible 6-minute walk distance on the 6MWT during the baseline visit, as a marker of clinical stability of the disease will be randomized. They will be a portable oxygen cylinder during 2 weeks when they realize activities. Receives: Drug: Ambulatory Oxygen |
| no oxygen cylinders | No intervention | Subjects randomised to be on air for the first two weeks of the treatment period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in K-BILD The King's Brief Interstitial Lung Disease Questionnaire health status score
The mean change vs baseline in the K-BILD health status score on and off ambulatory oxygen will be compared by using either a paired t-test or Wilcoxon signed rank test, as appropriate to the distribution of the data. To allow assessment of the effect of baseline values on treatment and any other potential confounders, regression with robust variances or linear mixed models will be used. STATA software will be used for statistical analysis.
Measured: February 2017 (up to 3 years)
Secondary outcomes (7)
Dyspnoea scores
assessed by the San Diego shortness of breath questionnaire.
Measured: 2 weeks
Global assessment of change in walking ability and exertional breathlessness as better, the same or worse.
Measured: 2 weeks
Quality of life as assessed by SGRQ and the hospital anxiety and depression score
Measured: 2 weeks
Sense wear activity monitor measures of daily number of steps walked, daily expenditure and time spent at different levels of activity.
Measured: 1 week
Continuous oxygen saturation for 48 hours at weekly intervals
Measured: 48 hours
Individual questions specifically related to activity from both the k-BILD and the SOBQ questionnaires
Measured: 2 weeks
Qualitative assessment of the impact of ambulatory oxygen
semi-structured open-ended interviews in a subset of 20 patients and their carers
Measured: 2 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startAug 2014
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
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 Lung; Disease, Fibroid (Chronic)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Elizabeth Renzoni, Dr, Study chair, RB&HFT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286063
- Sponsor's protocol ID
- 2013OE005B
- Other IDs
- 2013-004355-20
- Acronym
- AmbOx
- Status last verified
- Jun 2018
- First submitted
- 8 Oct 2014
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Visca D, Mori L, Tsipouri V, Fleming S, Firouzi A, Bonini M, Pavitt MJ, Alfieri V, Canu S, Bonifazi M, Boccabella C, De Lauretis A, Stock CJW, Saunders P, Montgomery A, Hogben C, Stockford A, Pittet M, Brown J, Chua F, George PM, Molyneaux PL, Margaritopoulos GA, Kokosi M, Kouranos V, Russell AM, Birring SS, Chetta A, Maher TM, Cullinan P, Hopkinson NS, Banya W, Whitty JA, Adamali H, Spencer LG, Farquhar M, Sestini P, Wells AU, Renzoni EA. Effect of ambulatory oxygen on quality of life for patients with fibrotic lung disease (AmbOx): a prospective, open-label, mixed-method, crossover randomised controlled trial. Lancet Respir Med. 2018 Oct;6(10):759-770. doi: 10.1016/S2213-2600(18)30289-3. Epub 2018 Aug 28.
PubMed 30170904Visca D, Tsipouri V, Mori L, Firouzi A, Fleming S, Farquhar M, Leung E, Maher TM, Cullinan P, Hopkinson N, Wells AU, Banya W, Whitty JA, Adamali H, Spencer LG, Sestini P, Renzoni EA. Ambulatory oxygen in fibrotic lung disease (AmbOx): study protocol for a randomised controlled trial. Trials. 2017 Apr 28;18(1):201. doi: 10.1186/s13063-017-1912-9.
PubMed 28454553
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Crossover Trial to Evaluate the Effects of Ambulatory Oxygen on Health Status in Patients With Fibrotic Lung Disease (FLD).
- ClinicalTrials.gov ID
- NCT02286063
- Acronym / sponsor ID
- AmbOx / 2013OE005B
- Conditions
- Lung; Disease, Fibroid (Chronic)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Liverpool University Hospitals NHS Foundation Trust, National Institute for Health Research, United Kingdom
- Study start
- Aug 2014
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 7 Nov 2014 (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.
The main aim of this project is to establish whether ambulatory oxygen in patients with fibrotic ILD whose oxygen saturation falls ≤ 88% on a 6MWT, leads to a significant improvement in health status. The core of the project will be a four week randomised, crossover controlled trial of ambulatory oxygen used during daily activities. The optimal Oxygen flow rate is determined by titration at screening visit and administered during activity for a two-week period, compared to two weeks off oxygen.
Detailed description
The planned non-commercial study is a randomised, controlled crossover trial of ambulatory oxygen against no ambulatory oxygen over a four week period (two weeks on ambulatory oxygen and two weeks on air, with no portable devices), to evaluate the effects of ambulatory oxygen on health status in patients with ILD. A short crossover study in this context has many advantages, since ambulatory oxygen has immediate effect, with no wash-out period needed after use. The primary outcome of the study will be the change in health status, as measured by the K-BILD questionnaire (Thorax 2012 67: 804-810).
At the start of the trial, the effects of ambulatory oxygen on 6 Minute Walk Test (6MWT) parameters will be evaluated on oxygen and on air-filled canisters, with the patient blind to the contents of the canister, to assess whether oxygen-induced improvements in 6MWT parameters can predict its effectiveness in day to day life. The 6MWT is a well established and highly reproducible test validated in ILD patients, with significant prognostic implications.
The study design does not include a placebo arm because:
- The intervention is a combination of possible benefits from oxygen and the disadvantage of canister weight. These cannot be separated. Placebo control is impossible because there is no means of providing placebo weight. Attempts to control solely for oxygen use without taking canister weight into account are clinically meaningless. In a recent COPD, chronic obstructive pulmonary disease study, cylinder weight was reported as a barrier to use by 93% of study participants.
- A positive result against an air-filled canister arm would be clinically uninterpretable. This is a study design in which the 'placebo' would be actively harmful to study participants. Carriage of an air-filled cylinder would be expected to lead to earlier desaturation and reduced exercise tolerance. Such a design would not inform the real life comparison between oxygen plus cylinder and no intervention.
- All this aside, blinding is legally impossible (UK health and safety regulations require that oxygen cylinders for home use must be clearly labelled).
It should also be stressed that objective measures of change are evaluated as secondary end-points: the investigators expect to explore correlations between these variables and the primary end-point to exclude the possibility that an observed treatment benefit on the primary end-point might be confounded by a placebo effect.
A more in depth qualitative assessment of the impact of ambulatory oxygen will be undertaken via a semi-structured interview, in a subset of 20 patients, to investigate patients' and their carers' personal perspective on how the ambulatory oxygen has affected their day to day life. The interview will be conducted within 2 weeks of the end of treatment visit. Patients from the Royal Brompton Hospital site will be approached by the researcher at the end of treatment visit and asked if they will participate in the qualitative assessment. If the patient agrees a date will be agreed for the patient to be interviewed at a venue convenient to them (usually the patient's home).
During the interviews a semi-structured topic guide will address practical barriers to optimal oxygen usage, practical, social and psychological difficulties encountered, concerned about dependency, and views on the information required prior to ambulatory oxygen prescription. The interviews will also explore patients' (and carers') experience of participating in the trial. Notes will be written after each interview to aid reflective analytical processes. Individual feed back on how the system and the service could be improved will assess how the needs of patients and their future involvement can be incorporated into the design of more patients and their future involvement can be incorporated into the design of more patients centred devices.
Qualitative interview analysis: Interviews will be transcribed verbatim. Interview transcripts will be analysed thematically using a framework approach. Atlas/ti computer software (http://atlasti.com) will be used to manage and index the data prior to charting, mapping and interpretation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ambulatory oxygen cylinders | Active comparator | Drug: Ambulatory OxygenSubjects randomised to have the intervention of portable oxygen for the first two weeks. Only patients with stable symptoms at the end of the 'run in' period and reproducible 6-minute walk distance on the 6MWT during the baseline visit, as a marker of clinical stability of the disease will be randomized. They will be a portable oxygen cylinder during 2 weeks when they realize activities. |
| no oxygen cylinders | No intervention | –Subjects randomised to be on air for the first two weeks of the treatment period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- IPF or another fibrotic ILD (including fibrotic NSIP, fibrotic organising pneumoni, and fibrotic hypersensitivity pneumonitis)
- patients aged 18 - 99 yrs
- Desaturation ≤ 88% on a 6MWT on room air
- Stable respiratory symptoms in the 4 weeks preceding the trial including the run in period
Key exclusion criteria (6 listed)
- Patients meeting criteria for long term oxygen therapy, including hypercapnic patients
- Patients expected to change treatment during the course of the study
- Significant locomotor or communication difficulties and/or severe co-morbidities
- Patients with sarcoidosis or connective tissue disease affecting the musculoskeletal system
- Current smokers
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 |
|---|---|---|
| Ambulatory OxygenAlso: portable oxygen cylinders, light weight oxygen cylindersThe IMP investigated in this study is medical oxygen (PL 15929/005), manufactured by Air Liquide Ltd. UK. Oxygen is a colourless, odourless gas with molecular weight 32, a boiling point of 183.1°C (at 1 bar) and a density of 1.355 kg/m3 (at 15°C and 1013mb). Oxygen is present in the atmosphere at 21% and is an absolute necessity for life. Each of the four oxygen companies across the UK provide a light and a standard weight oxygen cylinder. Ambulatory Oxygen will be given to the Oxygen arm. | Drug | ambulatory oxygen cylinders |
Primary outcome
change in K-BILD The King's Brief Interstitial Lung Disease Questionnaire health status score
Time frame: February 2017 (up to 3 years)
The mean change vs baseline in the K-BILD health status score on and off ambulatory oxygen will be compared by using either a paired t-test or Wilcoxon signed rank test, as appropriate to the distribution of the data. To allow assessment of the effect of baseline values on treatment and any other potential confounders, regression with robust variances or linear mixed models will be used. STATA software will be used for statistical analysis.
7 secondary outcomes
Dyspnoea scores
Time frame: 2 weeks
Global assessment of change in walking ability and exertional breathlessness as better, the same or worse.
Time frame: 2 weeks
Quality of life as assessed by SGRQ and the hospital anxiety and depression score
Time frame: 2 weeks
Sense wear activity monitor measures of daily number of steps walked, daily expenditure and time spent at different levels of activity.
Time frame: 1 week
Continuous oxygen saturation for 48 hours at weekly intervals
Time frame: 48 hours
Individual questions specifically related to activity from both the k-BILD and the SOBQ questionnaires
Time frame: 2 weeks
Qualitative assessment of the impact of ambulatory oxygen
Time frame: 2 weeks of treatment
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 26 Jun 2018.
- Derived from this study: PubMed 30170904Visca D, Mori L, Tsipouri V, Fleming S, Firouzi A, Bonini M, Pavitt MJ, Alfieri V, Canu S, Bonifazi M, Boccabella C, De Lauretis A, Stock CJW, Saunders P, Montgomery A, Hogben C, Stockford A, Pittet M, Brown J, Chua F, George PM, Molyneaux PL, Margaritopoulos GA, Kokosi M, Kouranos V, Russell AM, Birring SS, Chetta A, Maher TM, Cullinan P, Hopkinson NS, Banya W, Whitty JA, Adamali H, Spencer LG, Farquhar M, Sestini P, Wells AU, Renzoni EA. Effect of ambulatory oxygen on quality of life for patients with fibrotic lung disease (AmbOx): a prospective, open-label, mixed-method, crossover randomised controlled trial. Lancet Respir Med. 2018 Oct;6(10):759-770. doi: 10.1016/S2213-2600(18)30289-3. Epub 2018 Aug 28.
- Derived from this study: PubMed 28454553Visca D, Tsipouri V, Mori L, Firouzi A, Fleming S, Farquhar M, Leung E, Maher TM, Cullinan P, Hopkinson N, Wells AU, Banya W, Whitty JA, Adamali H, Spencer LG, Sestini P, Renzoni EA. Ambulatory oxygen in fibrotic lung disease (AmbOx): study protocol for a randomised controlled trial. Trials. 2017 Apr 28;18(1):201. doi: 10.1186/s13063-017-1912-9.
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.
Elizabeth Renzoni, Dr study chair
RB&HFT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ambulatory Oxygen in people with Lung; Disease, Fibroid (Chronic), 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 6 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 26 Jun 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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 K-BILD The King's Brief Interstitial Lung Disease Questionnaire health status score (time frame: February 2017 (up to 3 years)). 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 NCT02286063, 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 26 Jun 2018.