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

NCT00871962 | Unknown DMC

• 1 other identifier: ANTADIR 2009 - COHORTE
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

long-term oxygen therapy; COPD patients on necessity of long-term oxygen therapy

Outcome Measures

Primary Outcomes (1)

• Survival in function of initial hypoxemia, body mass index and cardiovascular events

  3 years

Secondary Outcomes (1)

• Long-term oxygen therapy observance and duration

  3 years

Study Arms (1)

1

COPD patients on necessity of long-term oxygen therapy

Other: OXYGEN SUPPLEMENTATION

Interventions

OXYGEN SUPPLEMENTATION OTHER

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%

Also known as: Patients with LTOT: survival

1

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

COPD patients on necessity of long-term oxygen therapy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche: lead

Study Sites (1)

Service de Pneumologie, Hôpital du Cluzeau

Limoges, 87042, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood gaz analysis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• MELLONI Boris, Pr

  Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2009
• First Posted: March 30, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: May 1, 2016
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

FR (1)