LTOT in COPD Patients With Moderate Chronic Hypoxemia and Chronic Heart Failure
NCT ID: NCT00668408
Last Updated: 2009-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
1000 participants
INTERVENTIONAL
2008-05-31
2012-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LTOT group
Study group: optimal medical therapy plus LTOT = or \> 15 hours pro die
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.
Non LTOT group
control group: optimal medical therapy without LTOT
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Congenital heart diseases
* Lung cancer
* Thoracic restrictive disorders
* Other coexisting diseases influencing 3-yr survival
40 Years
80 Years
ALL
No
Sponsors
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University of Modena and Reggio Emilia
OTHER
Azienda Ospedaliero-Universitaria Careggi
OTHER
Responsible Party
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Azienda Ospedaliero-Universitaria Careggi Firenze (UTIP)
Principal Investigators
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Antonio Corrado, MD
Role: PRINCIPAL_INVESTIGATOR
AOU Careggi
Locations
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Ausl 8 di Arezzo
Arezzo, AR, Italy
Azienda Ospedaliera S. G. Moscati
Avellino, AV, Italy
A.O. Universitaria Ospedale consorziale policlinico di Bari
Bari, BA, Italy
Presidio ospedaliero Barletta
Barletta, BA, Italy
Azienda ospedale G. Rummo
Benevento, BN, Italy
Irccs Fondazione Maugeri
Gussago, BS, Italy
Ospedale Roberto Binaghi
Cagliari, CA, Italy
Presidio Ospedaliero F.lli Crobu Iglesias
Iglesias, CI, Italy
Asp di Cosenza - Ambito territoriale di Castrovillari (ex asl 2)
Castrovillari, CS, Italy
Asp di Catanzaro - Ambito territoriale di catanzaro (ex asl 7)
Catanzaro, CZ, Italy
Azienda Ospedaliera Mater Domini
Catanzaro, CZ, Italy
Presidio Ospedaliero Morgagni-Pierantoni di Forlì
Forlì, FC, Italy
Presidio Ospedaliero Morgagni-Pierantoni
Forlì, FC, Italy
A.O. Universitaria Arcispedale S. Anna
Ferrara, FE, Italy
A.O. Universitaria Careggi
Florence, FI, Italy
Irccs fondazione Don Gnocchi - Centro S. Maria agli ulivi
Impruneta, FI, Italy
A.O. Universitaria S. Martino
Genova, GE, Italy
Ospedale della Misericordia
Grosseto, GR, Italy
Ospedale S. Andrea
Massa Marittima, GR, Italy
Stabilimento ospedaliero di Imperia
Imperia, IM, Italy
Ospedale generale prov. card. G. Panico
Tricase, LE, Italy
Ausl 2 di Lucca
Lucca, LU, Italy
Ospedale S. Giuseppe f.b.f.
Milan, MI, Italy
Ospedale civile di Vimercate
Vimercate, MI, Italy
Presidio Ospedaliero C. Poma
Mantova, MN, Italy
A.O. Universitaria policlinico di Modena
Modena, MO, Italy
Ospedale Civile di Carrara
Carrara, MS, Italy
A.O. V. Cervello
Palermo, PA, Italy
Presidio ospedaliero Civico e benfratelli
Palermo, PA, Italy
Aulss 15 alta padovana
Cittadella, PD, Italy
Azienda Ospedaliera di padova
Padua, PD, Italy
A.O. di Perugia - Ospedale S. Maria della Misericordia (ex Silvestrini)
Perugia, PG, Italy
Asl 2 di Perugia
Perugia, PG, Italy
A.O. Universitaria Pisana
Pisa, PI, Italy
Azienda Ospedaliera S. Maria degli angeli
Pordenone, PN, Italy
A.O. Universitaria di Parma
Parma, PR, Italy
Ausl 3 di Pistoia
Pistoia, PT, Italy
Irccs fondazione Maugeri
Montescano, PV, Italy
Irccs Fondazione Maugeri
Pavia, PV, Italy
Irccs policlinico S. Matteo
Pavia, PV, Italy
Ospedale S. Sebastiano
Correggio, RE, Italy
Ospedale di S. Maria Nuova
Reggio Emilia, RE, Italy
Ospedale S. Camillo De Lellis
Rieti, RI, Italy
Ausl rm/h di Albano Laziale
Albano Laziale, RM, Italy
A.O. Universitaria Policlinico Tor Vergata
Roma, RM, Italy
Az. Osp. San Camillo-Forlanini
Roma, RM, Italy
Az.osp.san camillo-forlanini -
Roma, RM, Italy
Aulss 18 di Rovigo
Rovigo, RO, Italy
Asl sa/2 di Salerno
Salerno, SA, Italy
A.O. Universitaria senese
Siena, SI, Italy
Presidio ospedaliero San Bartolomeo
Sarzana, SP, Italy
Azienda Ospedaliera Umberto I
Syracuse, SR, Italy
A.O. Universitaria Policlinico di Sassari
Sassari, SS, Italy
Az. Osp. Ospedale S. Corona
Pietra Ligure, SV, Italy
Ospedale Mazzini
Teramo, TE, Italy
Ospedale di Trento - P.O. S.Chiara
Trento, TN, Italy
A.O. Universitaria S. Giovanni Battista-Molinette di Torino
Torino, TO, Italy
A.O. Universitaria ospedali riuniti di Trieste
Trieste, TS, Italy
Ospedale di
Vicenza, VI, Italy
Ospedale civile Orlandi Bussolengo
Bussolengo, VR, Italy
Terapia Intensiva Pneumologica- AOU Careggi
Florence, , Italy
Azienda ospedaliera "A. Cardarelli"
Napoli, , Italy
Azienda Ospedaliera Antonio Cardarelli di Napoli
Napoli, , Italy
Azienda Ospedaliera Cotugno
Napoli, , Italy
A.O. Universitaria Maggiore della Carità
Novara, , Italy
Irccs Fondazione Maugeri
Veruno, , Italy
Countries
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Central Contacts
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Facility Contacts
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Antonio Corrado, MD
Role: primary
Teresa Renda, MD
Role: backup
Other Identifiers
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FARM6YHYW4
Identifier Type: -
Identifier Source: org_study_id