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
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 April 14, 2014