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

Sponsor
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche (Other)
Overall Status
Unknown status
CT.gov ID
NCT00871962
Collaborator
(none)
750
Enrollment
1
Location
83
Duration (Months)
9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
750 participants
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
Study Start Date :
Jun 1, 2009
Anticipated Primary Completion Date :
Dec 1, 2015
Anticipated Study Completion Date :
May 1, 2016

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Survival in function of initial hypoxemia, body mass index and cardiovascular events [3 years]

    Secondary Outcome Measures

    1. Long-term oxygen therapy observance and duration [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Pneumologie, Hôpital du Cluzeau Limoges. France 87042

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
    ClinicalTrials.gov Identifier:
    NCT00871962
    Other Study ID Numbers:
    • ANTADIR 2009 - COHORTE
    First Posted:
    Mar 30, 2009
    Last Update Posted:
    Jun 23, 2015
    Last Verified:
    Jun 1, 2015
    Keywords provided by Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
    long-term oxygen therapy
    COPD patients on necessity of long-term oxygen therapy
    Additional relevant MeSH terms:
    Lung Diseases
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive

    Study Results

    No Results Posted as of Jun 23, 2015