Lung Diseases, InterstitialHiFloILDNCT03816722
High Flow in Interstitial Lung Disease
A study testing Airvo2 in people with Lung Diseases, Interstitial, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
This is a prospective, 6 week cross-over study on the effect of High flow nasal cannula (HFNC) delivered air in patients with interstitial lung disease (ILD), in need of ambulatory oxygen therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Interstitial
- What is being tested?
- Airvo2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Feb 2019to 30 Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Patient diagnosed with interstitial lung disease
- Capable of understanding oral and written information and giving informed consent
- Newly diagnosed with need of oxygen during physical activity (SO2 <88%).
Who cannot join
- Pneumonia or exacerbation of ILD < 6 weeks prior to inclusion
- Other terminal disease than ILD and life expectancy < 3 months
- Patients not capable of understanding and accepting written or verbal information
- Patients with in need of continuous oxygen treatment at inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of High Flow, Nasal Cannula Delivered Air in Patients With Interstitial Lung Disease - a Pilot Study
This is a prospective, 6 week cross-over study on the effect of High flow nasal cannula (HFNC) delivered air in patients with interstitial lung disease (ILD), in need of ambulatory oxygen therapy.
Primary outcome:
Read more
To investigate intra-personal differences in 6MWT, as well as SO2 and BORG score at the end of the 6MWT, at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences in SGRQ at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences in quality of sleep, using the Richards-Campbell sleep questionnaire (RCSQ) at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences in IC, at baseline, at 6 weeks and 12 weeks
Secondary outcome:
To investigate intra-personal differences in FVC, at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences in DLCO at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences in mMRC-score at baseline, at 6 weeks and 12 weeks
Read the detailed description
In this pilot study we wish to investigate whether treatment with HFNC, delivered by MyAirvo2 (Fisher\&Paykel, Auckland, New Zealand) in patients with interstitial lung disease (ILD) in need of ambulatory oxygen therapy (AOT).
Ten patients will be recruited from the outpatient clinic at Department of Respiratory Diseases, Aalborg University Hospital.
The study is carried out as a cross over study, randomizing 5 patients to intitially 6 weeks' HFNC treatment as add on to the patients' personalized usual care followed by 6 weeks observation on usual care and 5 patients to 6 weeks' observation on the patients' personalized usual care, followed by 6 weeks with HFNC as add on to usual care.
At inclusion patients' background information will be registered and patients will be examined with body plethysmography, registering TLC, FVC, RV and IC, as well as DLCO. Furthermore, a 6MWT will be performed, monitoring peripheral oxygen saturation (SO2)and BORG score at the beginning and the end of the procedure as well as analysis of arterial blood gasses (PaO2, PaCO2) at rest. In addition the modified Medical Research Council (mMRC)- score; the Richards-Campbell Sleep Questionaire (RCSQ) and the St. George Respiratory Questionaire (SGRQ) will be carried out at baseline. Following this, patients will be randomized to either usual care or usual care plus HFNC, recommended flow 30 liters/minute, recommended temperature 37o Celsius, recommended use 8 hours/day, preferably at night. After 6 weeks body plethysmography, 6MWT, mMRC, SGRQ, RCSQ and arterial blood gas analysis will be repeated and following this, treatment will cross over; as such, patients initially in the usual care arm will be treated with HFNC as add on according to the recommendations stated above and the previous HFNC treated group will be referred to usual care for the following 6 weeks. At the end of the study period (t=12 weeks), body plethysmography, 6MWT, mMRC, RCSQ, SGRQ and arterial puncture will be repeated in all patients as well as background information will be revisited to note any changes.
Should the patient reach chronic respiratory failure (saturation at rest < 88%) during the study period, patients will remain in study and the airflow during HFNC be oxygenated with whatever amount of oxygen is required to reach saturation >88% during High Flow treatment.
Equipment:
Heated, humidified, air will be delivered to the patients by MyAirvo 2 (Fisher\&Paykel, Auckland, New Zealand). Patients will be treated with an intended flow of 30 L/min, intended use 8 hours per day, preferably nocturnal use. Should patients not tolerate the recommended flow, changes in flow are allowed. The Airvo2 device will be delivered and serviced in the patients' homes by VitalAire. Vitalaire will do readings of actual use on the device. At the end of the study, all patients will be offered continuous treatment with the device if so desired.
- Conditions
- Lung Diseases, Interstitial
- Being tested
- Airvo2, Usual care
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Airvo2Device
Treatment with HighFlow through the Airvo2 device, 8 hours per day
Usual careOther
Also called Ambulatory oxygen therapy, personalised medicine
High flow treatment is investigated as an add on treatment to the personalized care already prescribed to the patients. As patients with interstitial lung disease very often demand very different treatment set ups treatment will vary in the individual patients. All will, however, be treated with ambulatory oxygen. "Usual care" will be unaltered a month before inclusion in the study in each of the individual patients
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Patients starting the cross over with 6 weeks of high flow treatment with Airvo2 in addition to usual care Receives: Device: Airvo2; Other: Usual care |
| control | Experimental | Patients starting the cross over in the usual care Group but after 6 weeks receiving High Flow treatment with Airvo2 Receives: Device: Airvo2; Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test
walking distance
Measured: change between 6 and 12 weeks
SO2
oxygen saturation of the blood
Measured: change between 6 and 12 weeks
modified BORG score
score of dyspnea, ranging 0-10 where 0 is no dyspnea
Measured: 6 and 12 weeks
St George Respiratory Questionaire (SGRQ)
respiratory quality of life questionnaire, score with 20 questions all weighted in the final evaluation of the score. A change of 4 points is clinically relevant; a change of -4 an amelioration of quality of life
Measured: change between 6 and 12 weeks
Richards-Campbell's sleep questionnaire (RCSQ)
Quality of sleep questionnaire, based on 5 domains, evaluated individually by Visual Analog Scores(0-100), where 0 is the worst, 100 is the best outcome. All scores are equally weighted in the final score. The final, combined score is averaged, and expressed as a percentage of the total score
Measured: change between 6 and 12 weeks
inspiratory capacity
lung function measure (L, %)
Measured: change between 6 and 12 weeks
Secondary outcomes (3)
Forced Vital Capacity
lung function measure (L, %)
Measured: change between 6 and 12 weeks
diffusion capacity of the lung for carbon monoxide (DLCO)
diffusion capacity measure, (% of expected value)
Measured: change between 6 and 12 weeks
modified Medical Research Council score (mMRC-score)
dyspnea-score, scoring from 0-4 points
Measured: change between 6 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start15 Feb 2019
- Primary completion3 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Diseases, InterstitialStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, unblinded cross over study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Principal investigator, Ulla Møller Weinreich, Aalborg University Hospital
- Investigators
- Ulla M Weinreich, MD, PhD, Principal investigator, Aalborg University Hospital, Mølleparkvej 4, 9100 Aalborg, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03816722
- Sponsor's protocol ID
- N-20180070
- Acronym
- HiFloILD
- Status last verified
- Aug 2023
- First submitted
- 6 Dec 2018
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There a no IPD sharing plans at present
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Flow, Nasal Cannula Delivered Air in Patients With Interstitial Lung Disease - a Pilot Study
- ClinicalTrials.gov ID
- NCT03816722
- Acronym / sponsor ID
- HiFloILD / N-20180070
- Conditions
- Lung Diseases, Interstitial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 3 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 25 Jan 2019 (actual)
- 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 prospective, 6 week cross-over study on the effect of High flow nasal cannula (HFNC) delivered air in patients with interstitial lung disease (ILD), in need of ambulatory oxygen therapy.
Primary outcome:
To investigate intra-personal differences in 6MWT, as well as SO2 and BORG score at the end of the 6MWT, at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences in SGRQ at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences in quality of sleep, using the Richards-Campbell sleep questionnaire (RCSQ) at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences in IC, at baseline, at 6 weeks and 12 weeks
Secondary outcome:
To investigate intra-personal differences in FVC, at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences in DLCO at baseline, at 6 weeks and 12 weeks To investigate intra-personal differences in mMRC-score at baseline, at 6 weeks and 12 weeks
Detailed description
In this pilot study we wish to investigate whether treatment with HFNC, delivered by MyAirvo2 (Fisher\&Paykel, Auckland, New Zealand) in patients with interstitial lung disease (ILD) in need of ambulatory oxygen therapy (AOT).
Ten patients will be recruited from the outpatient clinic at Department of Respiratory Diseases, Aalborg University Hospital.
The study is carried out as a cross over study, randomizing 5 patients to intitially 6 weeks' HFNC treatment as add on to the patients' personalized usual care followed by 6 weeks observation on usual care and 5 patients to 6 weeks' observation on the patients' personalized usual care, followed by 6 weeks with HFNC as add on to usual care.
At inclusion patients' background information will be registered and patients will be examined with body plethysmography, registering TLC, FVC, RV and IC, as well as DLCO. Furthermore, a 6MWT will be performed, monitoring peripheral oxygen saturation (SO2)and BORG score at the beginning and the end of the procedure as well as analysis of arterial blood gasses (PaO2, PaCO2) at rest. In addition the modified Medical Research Council (mMRC)- score; the Richards-Campbell Sleep Questionaire (RCSQ) and the St. George Respiratory Questionaire (SGRQ) will be carried out at baseline. Following this, patients will be randomized to either usual care or usual care plus HFNC, recommended flow 30 liters/minute, recommended temperature 37o Celsius, recommended use 8 hours/day, preferably at night. After 6 weeks body plethysmography, 6MWT, mMRC, SGRQ, RCSQ and arterial blood gas analysis will be repeated and following this, treatment will cross over; as such, patients initially in the usual care arm will be treated with HFNC as add on according to the recommendations stated above and the previous HFNC treated group will be referred to usual care for the following 6 weeks. At the end of the study period (t=12 weeks), body plethysmography, 6MWT, mMRC, RCSQ, SGRQ and arterial puncture will be repeated in all patients as well as background information will be revisited to note any changes.
Should the patient reach chronic respiratory failure (saturation at rest < 88%) during the study period, patients will remain in study and the airflow during HFNC be oxygenated with whatever amount of oxygen is required to reach saturation >88% during High Flow treatment.
Equipment:
Heated, humidified, air will be delivered to the patients by MyAirvo 2 (Fisher\&Paykel, Auckland, New Zealand). Patients will be treated with an intended flow of 30 L/min, intended use 8 hours per day, preferably nocturnal use. Should patients not tolerate the recommended flow, changes in flow are allowed. The Airvo2 device will be delivered and serviced in the patients' homes by VitalAire. Vitalaire will do readings of actual use on the device. At the end of the study, all patients will be offered continuous treatment with the device if so desired.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, unblinded cross over study
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Device: Airvo2, Other: Usual carePatients starting the cross over with 6 weeks of high flow treatment with Airvo2 in addition to usual care |
| control | Experimental | Device: Airvo2, Other: Usual carePatients starting the cross over in the usual care Group but after 6 weeks receiving High Flow treatment with Airvo2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years old
- Patient diagnosed with interstitial lung disease
- Capable of understanding oral and written information and giving informed consent
- Newly diagnosed with need of oxygen during physical activity (SO2 <88%).
Key exclusion criteria (4 listed)
- Pneumonia or exacerbation of ILD < 6 weeks prior to inclusion
- Other terminal disease than ILD and life expectancy < 3 months
- Patients not capable of understanding and accepting written or verbal information
- Patients with in need of continuous oxygen treatment at inclusion
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 |
|---|---|---|
| Airvo2Treatment with HighFlow through the Airvo2 device, 8 hours per day | Device | control, intervention |
| Usual careAlso: Ambulatory oxygen therapy, personalised medicineHigh flow treatment is investigated as an add on treatment to the personalized care already prescribed to the patients. As patients with interstitial lung disease very often demand very different treatment set ups treatment will vary in the individual patients. All will, however, be treated with ambulatory oxygen. "Usual care" will be unaltered a month before inclusion in the study in each of the individual patients | Other | control, intervention |
Primary outcome
6 minute walk test
Time frame: change between 6 and 12 weeks
walking distance
SO2
Time frame: change between 6 and 12 weeks
oxygen saturation of the blood
modified BORG score
Time frame: 6 and 12 weeks
score of dyspnea, ranging 0-10 where 0 is no dyspnea
St George Respiratory Questionaire (SGRQ)
Time frame: change between 6 and 12 weeks
respiratory quality of life questionnaire, score with 20 questions all weighted in the final evaluation of the score. A change of 4 points is clinically relevant; a change of -4 an amelioration of quality of life
Richards-Campbell's sleep questionnaire (RCSQ)
Time frame: change between 6 and 12 weeks
Quality of sleep questionnaire, based on 5 domains, evaluated individually by Visual Analog Scores(0-100), where 0 is the worst, 100 is the best outcome. All scores are equally weighted in the final score. The final, combined score is averaged, and expressed as a percentage of the total score
inspiratory capacity
Time frame: change between 6 and 12 weeks
lung function measure (L, %)
3 secondary outcomes
Forced Vital Capacity
Time frame: change between 6 and 12 weeks
diffusion capacity of the lung for carbon monoxide (DLCO)
Time frame: change between 6 and 12 weeks
modified Medical Research Council score (mMRC-score)
Time frame: change between 6 and 12 weeks
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 3 Aug 2023.
- Individual participant dataSharing planned: No. There a no IPD sharing plans at present
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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.
Ulla M Weinreich, MD, PhD principal investigator
Aalborg University Hospital, Mølleparkvej 4, 9100 Aalborg, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airvo2 in people with Lung Diseases, Interstitial, run by Aalborg University Hospital at 1 site in Denmark.
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 4 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 3 Aug 2023. 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 Denmark. 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?
6 minute walk test (time frame: change between 6 and 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2023; AzTrials last refreshed its copy on 28 Oct 2026.