LTOT in COPD Patients With Moderate Chronic Hypoxemia and Chronic Heart Failure
- Conditions
- Lung Diseases, ObstructiveChronic Heart FailureChronic Hypoxemia
- Interventions
- Other: Pharmacological therapy of COPD and CHFOther: LTOT (oxygen therapy)
- Registration Number
- NCT00668408
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1000
- 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
- Clinical instability and/or exacerbation
- Congenital heart diseases
- Lung cancer
- Thoracic restrictive disorders
- Other coexisting diseases influencing 3-yr survival
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non LTOT group Pharmacological therapy of COPD and CHF control group: optimal medical therapy without LTOT LTOT group LTOT (oxygen therapy) Study group: optimal medical therapy plus LTOT = or \> 15 hours pro die
- Primary Outcome Measures
Name Time Method The primary outcome of the study is mortality. 3 years
- Secondary Outcome Measures
Name Time Method 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. 3 years
Trial Locations
- Locations (64)
Az. Osp. San Camillo-Forlanini
🇮🇹Roma, RM, Italy
Aulss 18 di Rovigo
🇮🇹Rovigo, RO, Italy
Asl sa/2 di Salerno
🇮🇹Salerno, SA, Italy
Presidio ospedaliero San Bartolomeo
🇮🇹Sarzana, SP, Italy
Azienda Ospedaliera Umberto I
🇮🇹Siracusa, SR, Italy
A.O. Universitaria S. Giovanni Battista-Molinette di Torino
🇮🇹Torino, TO, Italy
Azienda ospedaliera "A. Cardarelli"
🇮🇹Napoli, Italy
A.O. Universitaria Maggiore della Carità
🇮🇹Novara, Italy
Ausl 8 di Arezzo
🇮🇹Arezzo, AR, Italy
Azienda ospedale G. Rummo
🇮🇹Benevento, BN, Italy
Irccs Fondazione Maugeri
🇮🇹Veruno, Italy
A.O. Universitaria Arcispedale S. Anna
🇮🇹Ferrara, FE, Italy
A.O. Universitaria Careggi
🇮🇹Firenze, FI, Italy
Az.osp.san camillo-forlanini -
🇮🇹Roma, RM, Italy
Ospedale civile Orlandi Bussolengo
🇮🇹Bussolengo, VR, Italy
Ausl 2 di Lucca
🇮🇹Lucca, LU, Italy
A.O. Universitaria di Parma
🇮🇹Parma, PR, Italy
A.O. Universitaria senese
🇮🇹Siena, SI, Italy
A.O. Universitaria Policlinico di Sassari
🇮🇹Sassari, SS, Italy
Ospedale S. Camillo De Lellis
🇮🇹Rieti, RI, Italy
Ospedale Mazzini
🇮🇹Teramo, TE, Italy
Ospedale di Trento - P.O. S.Chiara
🇮🇹Trento, TN, Italy
A.O. Universitaria ospedali riuniti di Trieste
🇮🇹Trieste, TS, Italy
Ospedale di
🇮🇹Vicenza, VI, Italy
Terapia Intensiva Pneumologica- AOU Careggi
🇮🇹Firenze, Italy
Az. Osp. Ospedale S. Corona
🇮🇹Pietra Ligure, SV, Italy
Azienda Ospedaliera Cotugno
🇮🇹Napoli, Italy
Azienda Ospedaliera Antonio Cardarelli di Napoli
🇮🇹Napoli, Italy
Azienda Ospedaliera S. G. Moscati
🇮🇹Avellino, AV, Italy
Presidio ospedaliero Barletta
🇮🇹Barletta, BA, Italy
A.O. Universitaria Ospedale consorziale policlinico di Bari
🇮🇹Bari, BA, Italy
Ospedale Roberto Binaghi
🇮🇹Cagliari, CA, Italy
Presidio Ospedaliero Morgagni-Pierantoni di Forlì
🇮🇹Forlì, FC, Italy
Presidio Ospedaliero F.lli Crobu Iglesias
🇮🇹Iglesias, CI, Italy
Asp di Catanzaro - Ambito territoriale di catanzaro (ex asl 7)
🇮🇹Catanzaro, CZ, Italy
Azienda Ospedaliera Mater Domini
🇮🇹Catanzaro, CZ, Italy
Asp di Cosenza - Ambito territoriale di Castrovillari (ex asl 2)
🇮🇹Castrovillari, CS, Italy
Presidio Ospedaliero Morgagni-Pierantoni
🇮🇹Forlì, FC, 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 S. Giuseppe f.b.f.
🇮🇹Milano, MI, Italy
Ospedale generale prov. card. G. Panico
🇮🇹Tricase, LE, Italy
Ospedale civile di Vimercate
🇮🇹Vimercate, MI, Italy
A.O. Universitaria policlinico di Modena
🇮🇹Modena, MO, Italy
Presidio Ospedaliero C. Poma
🇮🇹Mantova, MN, Italy
Presidio ospedaliero Civico e benfratelli
🇮🇹Palermo, PA, Italy
Ospedale Civile di Carrara
🇮🇹Carrara, MS, Italy
A.O. V. Cervello
🇮🇹Palermo, PA, Italy
Asl 2 di Perugia
🇮🇹Perugia, PG, Italy
Aulss 15 alta padovana
🇮🇹Cittadella, PD, Italy
Azienda Ospedaliera di padova
🇮🇹Padova, PD, Italy
A.O. di Perugia - Ospedale S. Maria della Misericordia (ex Silvestrini)
🇮🇹Perugia, PG, Italy
Azienda Ospedaliera S. Maria degli angeli
🇮🇹Pordenone, PN, Italy
A.O. Universitaria Pisana
🇮🇹Pisa, PI, Italy
Ausl 3 di Pistoia
🇮🇹Pistoia, PT, Italy
Irccs fondazione Maugeri
🇮🇹Montescano, PV, Italy
Irccs policlinico S. Matteo
🇮🇹Pavia, PV, Italy
Ospedale di S. Maria Nuova
🇮🇹Reggio nell'Emilia, RE, Italy
A.O. Universitaria Policlinico Tor Vergata
🇮🇹Roma, RM, Italy
Ospedale S. Sebastiano
🇮🇹Correggio, RE, Italy
Ausl rm/h di Albano Laziale
🇮🇹Albano Laziale, RM, Italy