Status:

COMPLETED

NOWOX Oxygen Therapy Monitoring Device

Lead Sponsor:

Air Liquide SA

Conditions:

Chronic Obstructive Pulmonary Disease

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief Summary

The purpose of this study is to evaluate the duration of oxygen use recorded by the NOWOX, under usual conditions of daily living, in patients with chronic obstructive respiratory disease requiring ox...

Detailed Description

Long Term Oxygen Therapy (LTOT) is one of the main non pharmacologic treatments for patients with severe lung disease. This continuous or sub-continuous oxygen supplementation is generally introduced ...

Eligibility Criteria

Inclusion

  • Male or female patient aged ≥ 18 years and ≤ 75 years,
  • Having a documented diagnosis of moderately severe to severe chronic obstructive respiratory disease
  • Hospitalised or out-patient requiring transient or long term oxygen therapy,
  • Able to be weaned from oxygen for several consecutive minutes (around 30 minutes, SpO2 at rest on room air should not drop \< 85%),
  • Able to read
  • Willing and able to complete the requirements of this study including providing his/her signature for the written informed consent.

Exclusion

  • Clinically unstable patient,
  • Any contraindication to perform a light cycling exercise, according to the 2003 ATS/ACCP guidelines
  • Tracheostomy,
  • Nasal obstruction or acute rhinitis occurring in the week prior to selection,
  • For female patient:
  • Pregnant,
  • Positive urinary pregnancy test
  • Lactating mother or lack of efficient contraception
  • Clinically significant or uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, autoimmune, neurological or psychiatric disorders which may interfere with the study procedures,
  • Known allergic reactions to medical material compounds used in the study
  • Drug abuse or psychic disorders
  • Legal status which prohibits informed consent,
  • Participation in any interventional clinical trial within 30 days prior to selection.

Key Trial Info

Start Date :

November 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 1 2010

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT00800072

Start Date

November 1 2008

End Date

February 1 2010

Last Update

February 27 2014

Active Locations (1)

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1

Cochin University Hospital

Paris, France, 75014