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Oxygen Therapy in Cystic Fibrosis

NCT01586728 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2015-06-15

No results posted yet for this study

Summary

This is an open, multicenter, prospective, randomised and cross over study, comparing in patients with cystic fibrosis aged \> 6 years, 2 periods of 6 weeks of oxygen therapy or room air, separated by a wash out period of 2 to 6 weeks.

Conditions

Interventions

OTHER

Air - oxygen

1. his routine long term treatment without nocturnal oxygen therapy during 6 weeks (air period) 2. nocturnal oxygen therapy with a stable flow to obtain a nocturnal SpO2 \> 90% (oxygen period) while continuing his routine long term treatment during 6 weeks. During the oxygen period, the oxygen flow will be at least 1.5l/min. This flow may be increased up to 2L/min in case of the presence of nocturnal periods with SpO2 \<= 90%.

OTHER

Oxygen - Air

1. nocturnal oxygen therapy with a stable flow to obtain a nocturnal SpO2 \> 90% (oxygen period) while continuing his routine long term treatment during 6 weeks. 2. his routine long term treatment without nocturnal oxygen therapy during 6 weeks (air period) During the oxygen period, the oxygen flow will be at least 1.5l/min. This flow may be increased up to 2L/min in case of the presence of nocturnal periods with SpO2 \<= 90%.

Sponsors & Collaborators

  • Vaincre la Mucoviscidose

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Brigitte FAUROUX, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01586728 on ClinicalTrials.gov