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LTOT in COPD Patients With Moderate Chronic Hypoxemia and Chronic Heart Failure

NCT00668408 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2009-08-28

No results posted yet for this study

Summary

In patients with both COPD and CHF, moderate chronic hypoxemia is caused by a combination of intrapulmonary and extrapulmonary factors. The hypothesis of this study is that adequate medical therapy for both conditions can correct the moderate hypoxemia by improving the underlying mechanisms without the need of LTOT. If this hypothesis is correct, the study will provide a valuable information to the Italian Agency of drugs (Agenzia Italiana del Farmaco, AIFA) to reduce the inappropriate use of LTOT for COPD patients with moderate hypoxemia and CHF, and will help the Italian National Health Service to reduce both the direct and indirect costs of unnecessary LTOT.

Conditions

Interventions

OTHER

LTOT (oxygen therapy)

Patients on LTOT will receive oxygen for at least 15 hours/day from the liquid oxygen systems at a flow rate adjusted to raise resting SaO2 between 93 and 96% and / or PaO2 between 65 and 80 mmHg every day for 3 years.

OTHER

Pharmacological therapy of COPD and CHF

Optimal pharmacologic treatment will include : * Long (LABD, salmeterol, formoterol, tiotropium) - as well as short-acting (SABD, Salbutamol, terbutaline, ipratropium)bronchodilators (beta-2 agonists, anticholinergics) * Inhaled steroids (ICS, beclomethasone, fluticasone, budesonide always associated with LABD) * Beta-blockers * Diuretics * Angiotensin-converting enzyme (ACE) inhibitors alone or in associations with diuretics * Statins and any other treatment required for associated co-morbidities (eg insulin and/or anti-diabetic drugs, other antihypertensive, etc). The treatment of the deseases will follow the international guidelines.

Sponsors & Collaborators

  • University of Modena and Reggio Emilia

    collaborator OTHER

  • Azienda Ospedaliero-Universitaria Careggi

    lead OTHER

Principal Investigators

  • Antonio Corrado, MD · AOU Careggi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2012-03-31
Completion
2012-10-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00668408 on ClinicalTrials.gov