Oxygen Therapy in Cystic Fibrosis (MUCOXY)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Vaincre la Mucoviscidose
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01586728
First received: January 18, 2012
Last updated: March 4, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Cystic Fibrosis
Other: Air - oxygen
Other: Oxygen - Air

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Indication and Benefits of Nocturnal Oxygen Therapy in Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Air - oxygen
One period in room air and one period with nocturnal oxygen therapy, separated by a wash out period of 2 to 6 weeks.
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%.

Oxygen - Air
One period with nocturnal oxygen therapy and one period in room air, separated by a wash out period of 2 to 6 weeks.
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%.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01586728

Locations
France
Service de pneumologie pédiatrique, Hôpital Armand Trousseau
Paris, France, 75012
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Vaincre la Mucoviscidose
Investigators
Principal Investigator: Brigitte FAUROUX, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01586728     History of Changes
Other Study ID Numbers: P 100801
Study First Received: January 18, 2012
Last Updated: March 4, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Cystic fibrosis
oxygen therapy
sleep

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 16, 2014