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

This study is currently recruiting participants.
Verified February 2012 by Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
Sponsor:
Information provided by (Responsible Party):
Daniel VEALE, Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
ClinicalTrials.gov Identifier:
NCT00871962
First received: March 27, 2009
Last updated: February 6, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention
Chronic Obstructive Pulmonary Disease
 Other: OXYGEN SUPPLEMENTATION

Study Type: Observational
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire:

Primary Outcome Measures:
  • Survival in function of initial hypoxemia, body mass index and cardiovascular events [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Long-term oxygen therapy observance and duration [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Blood gaz analysis


Estimated Enrollment: 750
Study Start Date: June 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Patients with LTOT: survival

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

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

COPD patients on necessity of long-term oxygen therapy

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00871962

Contacts
Contact: Boris MELLONI, Pr 05 55 05 68 81 boris.melloni@unilim.fr

Locations
France
Service de Pneumologie, Hôpital du Cluzeau Recruiting
Limoges., France, 87042
Contact: Boris MELLONI, Pr     05 55 05 68 81     boris.melloni@unilim.fr    
Principal Investigator: Boris MELLONI, Pr            
Sponsors and Collaborators
Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
Investigators
Principal Investigator: MELLONI Boris, Pr Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
  More Information

No publications provided

Responsible Party: Daniel VEALE, Doctor (co-investigator), Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
ClinicalTrials.gov Identifier: NCT00871962     History of Changes
Other Study ID Numbers: ANTADIR 2009 - COHORTE
Study First Received: March 27, 2009
Last Updated: February 6, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire:
long-term oxygen therapy
COPD patients on necessity of long-term oxygen therapy

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013