Long-term Oxygen Treatment (LTOT) in Chronic Obstructive Pulmonary Disease: Factors Influencing Survival

Long-term Oxygen Treatment (LTOT) in Chronic Obstructive Pulmonary Disease: Factors Influencing Survival: Survival Factors in COPD Treated by Long-term Oxygen Therapy

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 Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: OXYGEN SUPPLEMENTATION

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.

• Study Type: Observational
• Enrollment (Anticipated): 750

Contacts and Locations

Study Locations

• France
  • Limoges., France, 87042
    • Service de Pneumologie, Hôpital du Cluzeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

COPD patients on necessity of long-term oxygen therapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

1; 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 Names: Patients with LTOT: survival

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival in function of initial hypoxemia, body mass index and cardiovascular events	3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Long-term oxygen therapy observance and duration	3 years

Collaborators and Investigators

• Sponsor: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
• Investigators: Principal Investigator: MELLONI Boris, Pr, Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): May 1, 2016

Study Registration Dates

• First Submitted: March 27, 2009
• First Submitted That Met QC Criteria: March 27, 2009
• First Posted (Estimate): March 30, 2009

Study Record Updates

• Last Update Posted (Estimate): June 23, 2015
• Last Update Submitted That Met QC Criteria: June 22, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: long-term oxygen therapy; COPD patients on necessity of long-term oxygen therapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ANTADIR 2009 - COHORTE