Pacientes con enfermedad pulmonar obstructiva crónica e hipoxemia (Stable chronic obstructive pulmonary disease with hypoxemia) MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Trade Name: Oxygen
Product Name: oxygen
Product Code: V03AN01
Pharmaceutical Form: Inhalation gas
INN or Proposed INN: oxigeno gas
Concentration unit: l litre(s)
Concentration type: equal
Concentrati
Sponsors
Servei Pneumologia. Hospital Universitari Son Dureta
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • >40 years. • COPD (ATS/ERS/GOLD II-IV). • PaO2 55-65 mmHg breathing room air. • Clinical stability (3 months from last exacerbation). • No changes from las three months. • Ex-smokers (> 3 months from last cigarette). • serum RCP > 3 mg/dl. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •No collaboration • Active smoking • Arterial PaO2 lower than 55mmHg • Hypercapnia (PaCO2 > 45 mmHg) • Sleep apnea syndrome • Obesity (BMI > 30 Kg/m2) • Presence of other chronic diseases • Systemic steroid or immunosupressor treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine pulmonary and systemic inflammatory markers in patients with COPD, hypoxemia (PaO2 55-65 mmHg) and systemic inflammation (CRP > 3mg/dl) before, at one week and two weeks after starting oxygentherapy (study group) and air (“sham” group) both administered by authorised concentrator (Company Airsep, model "Newlife") by Medical Device Directive, CE 459 . A third group with the same characteristics will be studied without any intervention.;Secondary Objective: No secondary objectives;Primary end point(s): Pulmonary and systemic inflammation (pro-inflammatory cytokines, CRP and oxidative stress) | — |
Countries
Spain
Outcome results
None listed