Benefits of liquid oxygen in chronic obstructive pulmonary disease (COPD) patients without evidence of domiciliary oxygen therapy, presenting desaturation on exertion.

Benefits of liquid oxygen in COPD patients without evidence of domiciliary oxygen therapy, presenting desaturation on exertion.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003619-24-ES

Enrollment

112

Registered

2013-12-13

Start date

2014-02-26

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe COPD patients: FEV1 80% of the reference values (GesEPOC Stadium II-IV/GOLD III-IV)

Interventions

Trade Name: Oxígeno medicinal líquido Linde gas medicinal criogénico 99.5% V/V en recipiente criogénicos móviles, 1 recipiente criogénico móvil de 30l Product Name: Liquefied medicinal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients diagnosed with moderate - severe COPD (FEV1 80% of the reference values (GesEPOC Stadium II-IV/GOLD III-IV) - Do not meet conventional criteria for Long term oxygen therapy (LTOT) indication (SEPAR Guides and GOLD) - Stability clinic in the last month - Optimized medical treatment - SpO2 mean ? 88% in the six minute walking test (6MWT) - Active life Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: - Current smokers - Respiratory failure with criteria for LTOT (PaO2 <55 mmHg or 55-60 mmHg associated with pulmonary hypertension, cor pulmonale, congestive heart failure, arrhythmias or polycythemia). - Impaired mobility - Cognitive impairment or intellectual disability - Disagreement to use liquid oxygen out of home - Severe comorbidities - Participation in pulmonary rehabilitation program

Design outcomes

Primary

Measure	Time frame
Main Objective: To analyze the benefits the adequate correction of oxygen desaturation during exercise in COPD patients without conventional criteria for LTOT in terms of the health related quality of life.;Secondary Objective: To analyze the improvement in dyspnea, exercise capacity, physical activity and adherence the treatment.;Primary end point(s): Health releated quality of live (HRQOL): increase of 0.5 points or more per domain in the CRQ questionnaire and/or improvement in 2 or more points in the CAT questionnaire were considered as the minimal importance difference.;Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

Main Objective: To analyze the benefits the adequate correction of oxygen desaturation during exercise in COPD patients without conventional criteria for LTOT in terms of the health related quality of life.;Secondary Objective: To analyze the improvement in dyspnea, exercise capacity, physical activity and adherence the treatment.;Primary end point(s): Health releated quality of live (HRQOL): increase of 0.5 points or more per domain in the CRQ questionnaire and/or improvement in 2 or more points in the CAT questionnaire were considered as the minimal importance difference.;Timepoint(s) of evaluation of this end point: 3 months

—

Secondary

Measure	Time frame
Secondary end point(s): 1. ? Dyspnoea improvement measured by MRC scale. 2.- Increase at least 27 meters of the distance of the 6 minutes walking test. 3. ? Increase of the physical activity measured by accelerometer. 4. - Adherence. Hours using oxygen (Visionox ® device). ;Timepoint(s) of evaluation of this end point: 3 months	—

Countries

Spain

Contacts

Public ContactMaria Rosa Güell-Rous

Grup ROV de la Societat Catalana de Pneumologia (SOCAP)

mguellr@santpau.cat

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026