AzTrials
AzTrials

Lung Diseases, ObstructivePhase 4NCT00668408

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

A Phase 4 study testing LTOT (oxygen therapy) and Pharmacological therapy of COPD and CHF in people with Lung Diseases, Obstructive and Chronic Heart Failure, run by Azienda Ospedaliero-Universitaria Careggi at 66 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
What is being tested?
LTOT (oxygen therapy) and Pharmacological therapy of COPD and CHF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
66 sitesItaly
Study dates
May 2008to Oct 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

66 sites in 1 country.

Antonio Corrado, MD contact

39-055-794-6559 ext. 055

corradoa@aou-careggi.toscana.it

Teresa Renda, MD, PhD contact

39-328-977-9239

rendateresa@hotmail.it

66 sites in 1 country

Italy66 sites, 10 recruiting

  • Ausl rm/h di Albano Laziale

    Albano Laziale, RM

    Active, not recruiting

  • Ausl 8 di Arezzo

    Arezzo, AR

    Active, not recruiting

  • Azienda Ospedaliera S. G. Moscati

    Avellino, AV

    Active, not recruiting

  • A.O. Universitaria Ospedale consorziale policlinico di Bari

    Bari, BA

    Renato De Tullio

    Recruiting

  • Presidio ospedaliero Barletta

    Barletta, BA

    Franco Dadduzio

    Recruiting

  • Azienda ospedale G. Rummo

    Benevento, BN

    Active, not recruiting

  • Ospedale civile Orlandi Bussolengo

    Bussolengo, VR

    Active, not recruiting

  • Ospedale Roberto Binaghi

    Cagliari, CA

    Active, not recruiting

  • Ospedale Civile di Carrara

    Carrara, MS

    Rigoletta Vincenti

    Recruiting

  • Asp di Cosenza - Ambito territoriale di Castrovillari (ex asl 2)

    Castrovillari, CS

    Active, not recruiting

  • Asp di Catanzaro - Ambito territoriale di catanzaro (ex asl 7)

    Catanzaro, CZ

    Active, not recruiting

  • Azienda Ospedaliera Mater Domini

    Catanzaro, CZ

    Active, not recruiting

  • Aulss 15 alta padovana

    Cittadella, PD

    Active, not recruiting

  • Ospedale S. Sebastiano

    Correggio, RE

    Active, not recruiting

  • A.O. Universitaria Arcispedale S. Anna

    Ferrara, FE

    Active, not recruiting

  • A.O. Universitaria Careggi

    Florence, FI

    Sandra Nutini

    Recruiting

  • Terapia Intensiva Pneumologica- AOU Careggi

    Florence, 50134

    Antonio Corrado, MD, 39-055-794-6559 ext. 055, corradoa@aou-careggi.toscana.it

    Teresa Renda, MD, 39-328-977-9239, rendateresa@hotmail.it

    Recruiting

  • Presidio Ospedaliero Morgagni-Pierantoni di Forlì

    Forlì, FC

    Active, not recruiting

  • Presidio Ospedaliero Morgagni-Pierantoni

    Forlì, FC

    Active, not recruiting

  • A.O. Universitaria S. Martino

    Genova, GE

    Active, not recruiting

  • Ospedale della Misericordia

    Grosseto, GR

    Active, not recruiting

  • Irccs Fondazione Maugeri

    Gussago, BS

    Active, not recruiting

  • Presidio Ospedaliero F.lli Crobu Iglesias

    Iglesias, CI

    Active, not recruiting

  • Stabilimento ospedaliero di Imperia

    Imperia, IM

    Active, not recruiting

  • Irccs fondazione Don Gnocchi - Centro S. Maria agli ulivi

    Impruneta, FI

    Active, not recruiting

  • Ausl 2 di Lucca

    Lucca, LU

    Active, not recruiting

  • Presidio Ospedaliero C. Poma

    Mantua, MN

    Active, not recruiting

  • Ospedale S. Andrea

    Massa Marittima, GR

    Active, not recruiting

  • Ospedale S. Giuseppe f.b.f.

    Milan, MI

    Active, not recruiting

  • A.O. Universitaria policlinico di Modena

    Modena, MO

    Active, not recruiting

  • Irccs fondazione Maugeri

    Montescano, PV

    Active, not recruiting

  • Azienda ospedaliera "A. Cardarelli"

    Naples

    Active, not recruiting

  • Azienda Ospedaliera Antonio Cardarelli di Napoli

    Naples

    Active, not recruiting

  • Azienda Ospedaliera Cotugno

    Naples

    Active, not recruiting

  • A.O. Universitaria Maggiore della Carità

    Novara

    Active, not recruiting

  • Azienda Ospedaliera di padova

    Padova, PD

    Active, not recruiting

  • A.O. V. Cervello

    Palermo, PA

    Active, not recruiting

  • Presidio ospedaliero Civico e benfratelli

    Palermo, PA

    Active, not recruiting

  • A.O. Universitaria di Parma

    Parma, PR

    Active, not recruiting

  • Irccs Fondazione Maugeri

    Pavia, PV

    Stefano Nava

    Recruiting

  • Irccs policlinico S. Matteo

    Pavia, PV

    Isa Cerveri

    Recruiting

  • A.O. di Perugia - Ospedale S. Maria della Misericordia (ex Silvestrini)

    Perugia, PG

    Active, not recruiting

  • Asl 2 di Perugia

    Perugia, PG

    Active, not recruiting

  • Az. Osp. Ospedale S. Corona

    Pietra Ligure, SV

    Active, not recruiting

  • A.O. Universitaria Pisana

    Pisa, PI

    Pierluigi Paggiaro

    Recruiting

  • Ausl 3 di Pistoia

    Pistoia, PT

    Active, not recruiting

  • Azienda Ospedaliera S. Maria degli angeli

    Pordenone, PN

    Active, not recruiting

  • Ospedale di S. Maria Nuova

    Reggio Emilia, RE

    Luigi Zucchi

    Recruiting

  • Ospedale S. Camillo De Lellis

    Rieti, RI

    Active, not recruiting

  • A.O. Universitaria Policlinico Tor Vergata

    Roma, RM

    Active, not recruiting

  • Az. Osp. San Camillo-Forlanini

    Roma, RM

    Active, not recruiting

  • Az.osp.san camillo-forlanini -

    Roma, RM

    Active, not recruiting

  • Aulss 18 di Rovigo

    Rovigo, RO

    Active, not recruiting

  • Asl sa/2 di Salerno

    Salerno, SA

    Pasquale Capano

    Recruiting

  • Presidio ospedaliero San Bartolomeo

    Sarzana, SP

    Active, not recruiting

  • A.O. Universitaria Policlinico di Sassari

    Sassari, SS

    Active, not recruiting

  • A.O. Universitaria senese

    Siena, SI

    Active, not recruiting

  • Azienda Ospedaliera Umberto I

    Syracuse, SR

    Active, not recruiting

  • Ospedale Mazzini

    Teramo, TE

    Active, not recruiting

  • A.O. Universitaria S. Giovanni Battista-Molinette di Torino

    Torino, TO

    Active, not recruiting

  • Ospedale di Trento - P.O. S.Chiara

    Trento, TN

    Active, not recruiting

  • Ospedale generale prov. card. G. Panico

    Tricase, LE

    Active, not recruiting

  • A.O. Universitaria ospedali riuniti di Trieste

    Trieste, TS

    Active, not recruiting

  • Irccs Fondazione Maugeri

    Veruno

    Active, not recruiting

  • Ospedale di

    Vicenza, VI

    Active, not recruiting

  • Ospedale civile di Vimercate

    Vimercate, MI

    Active, not recruiting

Other trials in Italy

About this study

Official title: Long-Term Oxygen Therapy (LTOT) in Chronic Obstructive Pulmonary Disease (COPD) Patients With Moderate Chronic Hypoxemia and Chronic Heart Failure (CHF)

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.

Read the 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.

Being tested
LTOT (oxygen therapy), Pharmacological therapy of COPD and CHF
Keywords
OTLT, COPD, CHRONIC HYPOXEMIA, CHF
Medical subject headings
Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LTOT (oxygen therapy)Other

    Also called LTOT treatment

    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.

  • Pharmacological therapy of COPD and CHFOther

    Also called Pharmacological treatment

    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.

Study groups in NCT00668408
Study groupRoleWhat they receive
LTOT groupOtherStudy group: optimal medical therapy plus LTOT = or > 15 hours pro die
Receives: Other: LTOT (oxygen therapy)
Non LTOT groupOthercontrol group: optimal medical therapy without LTOT
Receives: Other: Pharmacological therapy of COPD and CHF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary outcome of the study is mortality.

    Measured: 3 years

Secondary outcomes (1)

  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.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionMar 2012 (estimated)
  4. Study completionOct 2012 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00668408
Sponsor's protocol ID
FARM6YHYW4
Status last verified
Aug 2009
First submitted
28 Apr 2008
Last updated
28 Aug 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing LTOT (oxygen therapy) and Pharmacological therapy of COPD and CHF in people with Lung Diseases, Obstructive and Chronic Heart Failure, run by Azienda Ospedaliero-Universitaria Careggi at 66 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 66 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Antonio Corrado, MD (39-055-794-6559 ext. 055, corradoa@aou-careggi.toscana.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome of the study is mortality. (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00668408.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2009.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in