LTOT in COPD Patients With Moderate Chronic Hypoxemia and Chronic Heart Failure
Long-Term Oxygen Therapy (LTOT) in Chronic Obstructive Pulmonary Disease (COPD) Patients With Moderate Chronic Hypoxemia and Chronic Heart Failure (CHF)
1 other identifier
interventional
1,000
1 country
66
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2008
Longer than P75 for phase_4
66 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2008
CompletedFirst Posted
Study publicly available on registry
April 29, 2008
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedAugust 28, 2009
August 1, 2009
3.8 years
April 28, 2008
August 27, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary outcome of the study is mortality.
3 years
Secondary Outcomes (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.
3 years
Study Arms (2)
LTOT group
OTHERStudy group: optimal medical therapy plus LTOT = or \> 15 hours pro die
Non LTOT group
OTHERcontrol group: optimal medical therapy without LTOT
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Clinical instability and/or exacerbation
- Congenital heart diseases
- Lung cancer
- Thoracic restrictive disorders
- Other coexisting diseases influencing 3-yr survival
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (66)
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, 50134, 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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonio Corrado, MD
AOU Careggi
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 28, 2008
First Posted
April 29, 2008
Study Start
May 1, 2008
Primary Completion
March 1, 2012
Study Completion
October 1, 2012
Last Updated
August 28, 2009
Record last verified: 2009-08