Long-term Oxygen Treatment (LTOT) in Chronic Obstructive Pulmonary Disease: Factors Influencing Survival
The purpose of this prospective cohort study is to determine factors involved in survival in new COPD patients treated by long-term oxygen therapy.
Background: long-term oxygen therapy is indicated in patients with severe COPD. No studies have been performed in the past 20-25 years to examine the results of early clinical trials. Further studies are necessary to understand the utility of oxygen therapy in severe COPD.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Long-term Oxygen Treatment (LTOT) in Chronic Obstructive Pulmonary Disease: Factors Influencing Survival: Survival Factors in COPD Treated by Long-term Oxygen Therapy|
- Survival in function of initial hypoxemia, body mass index and cardiovascular events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Long-term oxygen therapy observance and duration [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples Without DNA
Blood gaz analysis
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
COPD patients on necessity of long-term oxygen therapy
Other: OXYGEN SUPPLEMENTATION
Patients treated by LTOT, with or without clinically fulfilled criteria for LTOT, with PaO2<55mmHg or less at rest or during sleeping or less during exercise, if supplemental oxygen is demonstrated to improve the exercise-associated hypoxia. Patients with PaO2 56-59mmHg if they also have dependent edema, pulmonary hypertension or hematocrit higher than 56%
Other Name: Patients with LTOT: survival
long-term oxygen therapy prolongs life in patients with severe COPD and severe resting hypoxemia. The objective of this study is to measure the survival in relation to the level of initial resting hypoxemia, serious co-morbidities, and nutritional status in COPD patients treated by long-term oxygen therapy. After enrollment at the beginning of oxygen therapy, following data will be collected during 3 years. Lung function, blood gas analysis, exercise capacity measured by the 6-Min Walk Distance test (6-MWD), dyspnea scale, BODE index, quality of life, indirect and direct costs will be analyzed every year.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00871962
|Service de Pneumologie, Hôpital du Cluzeau|
|Limoges., France, 87042|
|Principal Investigator:||MELLONI Boris, Pr||Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche|