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

Phase 1

• Conditions: Moderate to severe COPD patients: FEV1 <70%, FEV1/FVC <70%, TLC> 80% of the reference values (GesEPOC Stadium II-IV/GOLD III-IV); Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-003619-24-ES
• Lead Sponsor: ourdes Lozano-Bailen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-13
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 112

Inclusion Criteria

-Patients diagnosed with moderate - severe COPD (FEV1 <80%, FEV1/FVC <70%), total lung capacity (TLC)> 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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified