Clinical trial NCT00871962: Long-term Oxygen Treatment (LTOT) in Chronic Obstructive Pulmonary Disease: Factors Influencing Survival
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: long-term oxygen therapy
COPD patients on necessity of long-term oxygen therapy
Lead sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
Sponsor class: OTHER
First posted: 2009-03-30
Enrollment: 750
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COPD patients on necessity of long-term oxygen therapy

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* COPD patients on necessity of long-term oxygen therapy
* 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%
* Patient clinically stable
* Patient with oxygen device of ANTADIR network
* Oral and written consent

Exclusion Criteria:

* Patient with obstructive sleep apnea or overlap syndrome
* Patient with non invasive ventilation
* Patient with evolutive cancer.
* Inability to complete questionnaires
* Inability to attend outpatient clinic

Primary outcomes:
measure: Survival in function of initial hypoxemia, body mass index and cardiovascular events
timeFrame: 3 years
Secondary outcomes:
measure: Long-term oxygen therapy observance and duration
timeFrame: 3 years
Other outcomes:
Locations:
city: Limoges.
country: France
facility: Service de Pneumologie, Hôpital du Cluzeau
Study officials:
affiliation: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
name: MELLONI Boris, Pr
role: PRINCIPAL_INVESTIGATOR
References: