Ambulatory Oxygen Therapy for Individuals With Mild-to-moderate Interstitial Lung Disease

NCT06053164 | Recruiting Phase 2 DMC

• 1 other identifier: Pro00128503
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators plan to conduct a study to find out if giving portable oxygen therapy (during physical activity) to patients with interstitial lung disease will improve quality of life, exercise tolerance, shortness of breath, and blood vessel function. Oxygen will be provided for a period of 8 weeks. Additionally, the investigators plan to investigate if it is helpful to deliver individualized support when providing oxygen therapy, through check-in phone calls with a respiratory therapist and by providing additional educational material.

Conditions

Fibrotic Interstitial Lung Disease

Keywords

Exertional Oxygen; Ambulatory Oxygen; Interstitial Lung Disease

Outcome Measures

Primary Outcomes (4)

• Feasibility of investigation

  Number of patients recruited and completing the protocol in each arm

  2 years

• Exercise tolerance

  6 minute walk distance

  Before and immediately after the intervention

• Health Related Quality of Life, (EuroQol-5 Dimension-5 Level; EQ-5D-5L)

  Questionnaire for Health-Related Quality of Life. Possible Range = 5-25; 5 = 11111 (no problems on any dimension); 25 = 55555 (extreme problems on all dimensions)

  Before and immediately after the intervention

• Health Related Quality of Life, (King's Brief Interstitial Lung Disease Questionnaire; KBILD)

  Health status questionnaire. Domain and total score ranges are 0-100; 100 represents best health status

  Before and immediately after the intervention

Secondary Outcomes (6)

• Dyspnea (Dyspnea-12 Questionnaire)

  Before and immediately after the intervention

• Vascular function

  Before and immediately after the intervention

• Cough (Leicester cough questionnaire; LCQ)

  Before and immediately after the intervention

• Pulmonary Artery Pressure

  Before and immediately after the intervention

• Cardiac Output

  Before and immediately after the intervention

Study Arms (3)

Arm 1 - Usual Care

NO INTERVENTION

8 weeks of usual care with no supplemental oxygen provided

Arm 2 - Exertional Oxygen

EXPERIMENTAL

8 weeks of portable oxygen use (from a concentrator) during exertion

Drug: Exertional Oxygen

Arm 3 - Exertional Oxygen + Support

EXPERIMENTAL

8 weeks of portable oxygen use (from a concentrator) during exertion, plus additional phone calls with a respiratory educator and educational material

Drug: Exertional Oxygen; Behavioral: Education and Support

Interventions

Exertional Oxygen DRUG

Use of a portable oxygen concentrator for exertional activities lasting \>2 minutes

Also known as: Supplemental oxygen, ambulatory oxygen

Arm 2 - Exertional Oxygen; Arm 3 - Exertional Oxygen + Support

Education and Support BEHAVIORAL

Participants will receive disease-specific educational material (Living Well with Pulmonary Fibrosis: Oxygen), and will have scheduled phone appointments with a certified respiratory educator after 1, 3, and 5 weeks of oxygen therapy in order to address individual barriers to oxygen use and facilitate the optimal use of portable oxygen.

Arm 3 - Exertional Oxygen + Support

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with fibrotic ILD (all sub-groups of ILD) who have normal oxygen saturation at rest (SpO2 \> 90%) but develop exertional hypoxemia as demonstrated by a SpO2 = 80-89% with activity (measured during 6MWT).

You may not qualify if:

• Use of home oxygen therapy within the previous year for the management of ILD, co-morbid conditions that may require oxygen therapy (such as COPD, cardiovascular disease, or other illnesses), or individuals that require the use of non-invasive ventilation. Additionally, individuals with significant cardiovascular, metabolic, neuromuscular or any other disease that could contribute to dyspnea or abnormal cardiopulmonary responses to exercise will be excluded. Individuals with musculoskeletal injuries that prevent them from completing cycle ergometry exercise trials and ambulation will also be excluded. Individuals with peripheral vascular disease will be excluded from measurement of vascular function (flow mediated dilation).

Sponsors & Collaborators

• Alberta Boehringer Ingelheim Collaboration: collaborator
• University of Alberta: lead

Study Sites (1)

Clinical Physiology Laboratory

Edmonton, Alberta, T6G2R3, Canada

RECRUITING

Related Publications (3)

• Khor YH, Holland AE, Goh NSL, Miller BR, Vlahos R, Bozinovski S, Lahham A, Glaspole I, McDonald CF. Ambulatory Oxygen in Fibrotic Interstitial Lung Disease: A Pilot, Randomized, Triple-Blinded, Sham-Controlled Trial. Chest. 2020 Jul;158(1):234-244. doi: 10.1016/j.chest.2020.01.049. Epub 2020 Feb 28.

  PMID: 32113924 BACKGROUND

• Johannson KA, Pendharkar SR, Mathison K, Fell CD, Guenette JA, Kalluri M, Kolb M, Ryerson CJ. Supplemental Oxygen in Interstitial Lung Disease: An Art in Need of Science. Ann Am Thorac Soc. 2017 Sep;14(9):1373-1377. doi: 10.1513/AnnalsATS.201702-137OI.

  PMID: 28644693 BACKGROUND

• 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.

  PMID: 30170904 BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Educational Status; Palliative Care

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Mike Stickland

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matt Rieger, PhD

CONTACT

7804928027; mrieger@ualberta.ca

Desi Fuhr, MSc

CONTACT

780.492.1121; fuhr@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Single-blind investigation, investigator and assessors will be blinded to the condition/treatment arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-blind open-label randomized control

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: September 25, 2023
• Study Start: July 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)