Oxygen Therapy in Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 29 June 2015
• Main ID: NCT01586728
• Date of registration: 18/01/2012
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique - Hôpitaux de Paris
• Public title: Oxygen Therapy in Cystic Fibrosis MUCOXY
• Scientific title: Indication and Benefits of Nocturnal Oxygen Therapy in Cystic Fibrosis
• Date of first enrolment: October 2012
• Target sample size: 8
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01586728
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Brigitte FAUROUX, MD, PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion criteria

Inclusion Criteria:

- Children = 6 years and adults = 18 years with CF in a stable state

- With a forced expiratory volume in one second (FEV1) = 50% of predicted value

- Having a pulse oximetry (SpO2) in room air = 90% for = 10% of the night and/or a SpO2
= 90% for = 10 minutes during the night

- Any patient with prior noninvasive positive pressure ventilation (NPPV) but who has
stopped NPPV at least 15 days before the start of the study.

- Written approval by the patient and by the parents in case of a pediatric patient

- Patient having the French social security coverage

Exclusion Criteria:

- Patients with a respiratory exacerbation during the last 15 days

- Patients with NPPV or long term oxygen therapy prior to the start of the study and
unable to stop this treatment

- Impossibility of a medical examination

- Pregnant patient or breastfeeding patient



Age minimum: 6 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Other: Air - oxygen

Other: Oxygen - Air

Primary Outcome(s)

the improvement in nocturnal hypoxemia by the measurement of nocturnal pulse oximetry (SpO2) after 6 weeks of nocturnal oxygen therapy in stable patients with CF [Time Frame: after a 6 weeks period]

Secondary Outcome(s)

Comparison of a possible arterial pulmonary hypertension during oxygen therapy and room air after a period of 6 weeks by means of an echocardiography [Time Frame: after a 6 weeks period]

Comparison of subjective sleep quality during oxygen therapy and room air after a period of 6 weeks by means of 4 validated sleep questionnaires [Time Frame: after a 6 weeks period]

Detection of the appearance or increase in nocturnal hypercapnia during oxygen therapy and room air after a period of 6 weeks [Time Frame: after a 6 weeks period]

Comparison of quality of life during oxygen therapy and room air after a period of 6 weeks by means of a validated questionnaire for CF patients (CFQ). [Time Frame: after a 6 weeks period]

Secondary ID(s)

P 100801

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Vaincre la Mucoviscidose