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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 28, 2014