Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease
Treatment oxygen supplementation
Sponsor Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
Start date June 2009
End date December 2015
Trial size 750 participants
Trial identifier NCT00871962, ANTADIR 2009 - COHORTE

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
COPD patients on necessity of long-term oxygen therapy
oxygen supplementation Patients with LTOT: survival
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%

Primary Outcomes

Measure
Survival in function of initial hypoxemia, body mass index and cardiovascular events
time frame: 3 years

Secondary Outcomes

Measure
Long-term oxygen therapy observance and duration
time frame: 3 years

Eligibility Criteria

Male or female participants from 40 years up to 75 years old.

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

Additional Information

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
Principal investigator MELLONI Boris, Pr
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire.