Efficacy of Oxygen Therapy Delivered by Systems Using Oxygen-Saving Valves in COPD Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Daniel VEALE, Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire
ClinicalTrials.gov Identifier:
NCT01180803
First received: August 11, 2010
Last updated: February 7, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to compare the efficacy of oxygen therapy delivered by systems using oxygen-saving valves or not (continuous oxygen). We aim to determine if systems using oxygen-saving valves are equally effective as continuous oxygen delivery systems in reducing exercise-induced hypoxemia in patients with COPD.


Condition Intervention
LUNG DISEASES, OBSTRUCTIVE
Device: pulse oxygen supplementation devices
Device: continuous oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • oxygen saturation during 6 minutes walking test [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Walking distance during the 6 minutes walking test [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: July 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oxygen-saving valves Device: pulse oxygen supplementation devices
oxygen therapy delivered by systems using oxygen-saving valves
Other Name: pulse group
Active Comparator: continuous oxygen supplementation Device: continuous oxygen
oxygen therapy delivered by continuous liquid oxygen devices
Other Name: continuous group

  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COPD on necessity of long term oxygen therapy
  • Able to give their written consent

Exclusion Criteria:

  • Unstable patients with COPD
  • Patients with restrictive respiratory disease
  • Patients with cardiac or neurologic disease contre-indicating the different evaluations
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01180803

Contacts
Contact: Boris MELLONI, Pr +33 1. 56. 81. 40. 60 melloni@unilim.fr

Locations
France
Fédération ANTADIR Recruiting
Paris, France, 75006
Contact: Annabelle COUILLARD, Ph. D    +33.1.56.81.40.60    couillard@antadir.com   
Principal Investigator: Boris MELLONI, Pr         
Sponsors and Collaborators
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: NCT01180803     History of Changes
Other Study ID Numbers: EVAL- CLIN A00690-39
Study First Received: August 11, 2010
Last Updated: February 7, 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:
COPD - long term oxygenotherapy
COPD patients with respiratory failure

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 19, 2014