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

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ClinicalTrials.gov Identifier: NCT00668408
Recruitment Status : Unknown
Verified August 2009 by Azienda Ospedaliero-Universitaria Careggi.
Recruitment status was:  Recruiting
First Posted : April 29, 2008
Last Update Posted : August 28, 2009
University of Modena and Reggio Emilia
Information provided by:
Azienda Ospedaliero-Universitaria Careggi

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Diseases, Obstructive Chronic Heart Failure Chronic Hypoxemia Other: LTOT (oxygen therapy) Other: Pharmacological therapy of COPD and CHF Phase 4

Detailed Description:

Long-term oxygen treatment (LTOT) improves survival of COPD patients with severe hypoxemia . The improved survival was proven in COPD patients with severe chronic hypoxemia (PaO2< or = 55 mmHg), providing oxygen was delivered for = or >15 hours/day. Since then, > 15 hours/day LTOT has become the standard treatment for COPD patients with severe hypoxemia. LTOT has been extended without evidence to COPD patients with moderate hypoxemia (55< PaO2 <60mmHg), when associated with some clinical and laboratory signs of cardiac diseases and to patients with decreased oxygen saturation (SO2 < 90%) during exercise or sleep. Chronic heart failure (CHF) is a common co-morbidity of COPD (>30% ) particularly in the elderly. Whether LTOT improves survival in patients with moderate chronic hypoxemia and CHF is unknown. This is an issue of concern because of the potential importance of LTOT in severe COPD, and of the cost of LTOT (about Euro 250 millions/year in Italy). The aim of this 3 year randomized clinical trial is to investigate whether, in COPD patients with moderate hypoxemia associated with CHF treatment including LTOT is no different from treatment without LTOT in term of survival and of exacerbations, hospitalizations, and quality of life. The study will be conducted in 76 Italian hospital pulmonary units, and will start on May 15th 2008 and end on October 31st 2012. One thousand stable COPD patients treated according to COPD and CHF international guidelines will be randomized to treatment including LTOT (Study Group) or treatment without LTOT (Control Group). All patients will regularly undergo clinical assessment, arterial blood gases (3 monthly), and Saint George's Respiratory Questionnaire (SGRQ, 6 monthly),and will be contacted with monthly telephone calls.

Considering 1) the lack of evidence supporting LTOT in COPD patients with moderate hypoxemia and CHF, 2) the pathophysiology of CHF , and 3) the improvement of pharmacological treatment of both COPD and CHF, we expect that, after optimization of medical therapy, LTOT will not improve survival or frequency and severity of exacerbations and/or hospitalization, and not even quality of life due to the balance of small clinical benefits (improved exercise tolerance, better sleep) with the inconveniences associated with LTOT. This non-inferiority study is powered on survival, which is the primary outcome of the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-Term Oxygen Therapy (LTOT) in Chronic Obstructive Pulmonary Disease (COPD) Patients With Moderate Chronic Hypoxemia and Chronic Heart Failure (CHF)
Study Start Date : May 2008
Estimated Primary Completion Date : March 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
LTOT group
Study group: optimal medical therapy plus LTOT = or > 15 hours pro die
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 Name: LTOT treatment

Non LTOT group
control group: optimal medical therapy without LTOT
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.

Other Name: Pharmacological treatment

Primary Outcome Measures :
  1. The primary outcome of the study is mortality. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Secondary endpoint of the study is to evaluate whether the appropriate medical treatment without LTOT is not inferior to medical treatment with LTOT in terms of quality of life, rate and severity of exacerbation, number of hospital admissions. [ Time Frame: 3 years ]

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 40 > 80 years
  • Confirmed COPD (GOLD criteria)
  • Moderate and stable hypoxemia (55< PaO2 <65 mmHg)
  • Clinical signs of CHF (ESC criteria)
  • Ex-smokers (> 20 pack/years) since at least 3 months

Exclusion Criteria:

  • Clinical instability and/or exacerbation
  • Congenital heart diseases
  • Lung cancer
  • Thoracic restrictive disorders
  • Other coexisting diseases influencing 3-yr survival

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668408

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Contact: Antonio Corrado, MD 39-055-794-6559 ext 055 corradoa@aou-careggi.toscana.it
Contact: Teresa Renda, MD, PhD 39-328-977-9239 rendateresa@hotmail.it

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Sponsors and Collaborators
Azienda Ospedaliero-Universitaria Careggi
University of Modena and Reggio Emilia
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Principal Investigator: Antonio Corrado, MD AOU Careggi
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Responsible Party: Antonio Corrado, Azienda Ospedaliero-Universitaria Careggi Firenze (UTIP)
ClinicalTrials.gov Identifier: NCT00668408    
Other Study ID Numbers: FARM6YHYW4
First Posted: April 29, 2008    Key Record Dates
Last Update Posted: August 28, 2009
Last Verified: August 2009
Keywords provided by Azienda Ospedaliero-Universitaria Careggi:
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory