Impact of oxygen therapy in exertion in physical activity of patients with fibrotic intertitial lung disease with exertional hypoxemia (AFOX study)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Consorci Mar Parc De Salut De Barcelona

Participant type

Patients

Age range

65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2024-05-24

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

Feasibility study that evaluates the impact of oxygen therapy on exertion in physical activity measured by accelerometer (steps/day) in patients with fibrotic ILD with exertional hypoxemia (minimum SpO2 ≤ 88% in the 6MWT), at one month and after three months of follow-up.

Secondary objectives 3

1. To evaluate changes in the degree of dyspnea, quality of life and in symptoms of anxiety and depression in patients with fibrotic ILD and exertional hypoxemia, at one month and after three months of follow-up.
2. To evaluate changes in oxidative stress in peripheral blood of patients with supplemental oxygen during exercise compared to controls, without supplemental oxygen, at three months of follow-up.
3. To evaluate compliance of oxygen therapy on exertion in patients with fibrotic ILD with exertional hypoxemia, at one month and after three months of follow-up.

Conditions and MedDRA coding

Fibrotic interstitial lung disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patients aged greater than or equal to 18 years.
2. Patients with a diagnosis of fibrotic ILD, defined by the presence of peripheral reticulation, traction bronchiectasis, volume loss and/or presence of “honeycombing” on high-resolution chest CT (HRCT).
3. Patients with minimum SpO2 ≤ 88% in the 6MWT performed in room air.
4. Stability of respiratory symptoms two weeks prior to inclusion.

Exclusion criteria 8

1. SpO2 ≤ 93% at rest
2. Coexistence of other respiratory diseases such as COPD or asthma
3. Moderate-severe pulmonary hypertension measured by transthoracic echocardiography
4. Cardiological, osteo-articular or cognitive comorbidities that prevent correct performance of the 6MWT or a correct measurement of daily physical activity
5. Diagnosis of neoplasia in active treatment
6. Hospital admission 2 months prior to inclusion in the study
7. Current smoker
8. Being in a current pulmonary rehabilitation program

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in the number of steps per day comparing the control group and the intervention group.

Secondary endpoints 3

1. Changes in dyspnea questionnaire (dyspnea-12), quality of life (K-BILD) and anxiety and depression (HADS) between control and intervention group
2. Evaluate hours per day of oxygen therapy compliance
3. Analytical changes in oxidative stress between contol and intervention group

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Consorci Mar Parc De Salut De Barcelona

Sponsor organisation

Consorci Mar Parc De Salut De Barcelona

Address

Passeig Maritim De La Barceloneta 25-29

City

Barcelona

Postcode

08003

Country

Spain

Scientific contact point

Organisation

Consorci Mar Parc De Salut De Barcelona

Contact name

Eva Balcells

Public contact point

Organisation

Consorci Mar Parc De Salut De Barcelona

Contact name

Eva Balcells

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications