High Flow in Interstitial Lung Disease

NCT03816722 | Completed

• 1 other identifier: N-20180070
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Lung Diseases, Interstitial

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• inspiratory capacity

  lung function measure (L, %)

  change between 6 and 12 weeks

Secondary Outcomes (3)

• Forced Vital Capacity

  change between 6 and 12 weeks

• diffusion capacity of the lung for carbon monoxide (DLCO)

  change between 6 and 12 weeks

• modified Medical Research Council score (mMRC-score)

  change between 6 and 12 weeks

Study Arms (2)

intervention

EXPERIMENTAL

Patients starting the cross over with 6 weeks of high flow treatment with Airvo2 in addition to usual care

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

Device: Airvo2; Other: Usual care

Interventions

Airvo2 DEVICE

Treatment with HighFlow through the Airvo2 device, 8 hours per day

control; intervention

Usual care OTHER

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

Also known as: Ambulatory oxygen therapy, personalised medicine

control; intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).

You may not qualify if:

• Other terminal disease than ILD and life expectancy \< 3 months
• Patients not capable of understanding and accepting written or verbal information

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

Aalborg University Hospital

Aalborg, 9100, Denmark

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ulla M Weinreich, MD, PhD

  Aalborg University Hospital, Mølleparkvej 4, 9100 Aalborg, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: As blinding of high flow treatment in not possible this is an open label study
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investgator

Model Details: Prospective, unblinded cross over study

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: January 25, 2019
• Study Start: February 15, 2019
• Primary Completion: June 3, 2021
• Study Completion: June 30, 2021
• Last Updated: August 3, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)