High Flow in Interstitial Lung Disease (HiFloILD)

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:

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

Study Overview

• Status: Completed
• Conditions: Lung Diseases, Interstitial
• Intervention / Treatment: Device: Airvo2; Other: Usual care

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark, 9100
    • Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

• 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%).

Exclusion criteria

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention; Patients starting the cross over with 6 weeks of high flow treatment with Airvo2 in addition to usual care	Device: Airvo2; Treatment with HighFlow through the Airvo2 device, 8 hours per day; Other: Usual care; 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; Other Names: Ambulatory oxygen therapy, personalised medicine
Experimental: control; Patients starting the cross over in the usual care Group but after 6 weeks receiving High Flow treatment with Airvo2	Device: Airvo2; Treatment with HighFlow through the Airvo2 device, 8 hours per day; Other: Usual care; 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; Other Names: Ambulatory oxygen therapy, personalised medicine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minute walk test	walking distance	change between 6 and 12 weeks
SO2	oxygen saturation of the blood	change between 6 and 12 weeks
modified BORG score	score of dyspnea, ranging 0-10 where 0 is no dyspnea	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	change between 6 and 12 weeks
inspiratory capacity	lung function measure (L, %)	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	change between 6 and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Forced Vital Capacity	lung function measure (L, %)	change between 6 and 12 weeks
diffusion capacity of the lung for carbon monoxide (DLCO)	diffusion capacity measure, (% of expected value)	change between 6 and 12 weeks
modified Medical Research Council score (mMRC-score)	dyspnea-score, scoring from 0-4 points	change between 6 and 12 weeks

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Collaborators: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: Ulla M Weinreich, MD, PhD, Aalborg University Hospital, Mølleparkvej 4, 9100 Aalborg, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2019
• Primary Completion (Actual): June 3, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: January 24, 2019
• First Posted (Actual): January 25, 2019

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: N-20180070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There a no IPD sharing plans at present

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No