Oxygen Therapy in Cystic Fibrosis

NCT01586728 | Terminated

• 1 other identifier: P 100801
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Cystic Fibrosis

Keywords

Cystic fibrosis; oxygen therapy; sleep

Outcome Measures

Primary Outcomes (1)

• 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

  after a 6 weeks period

Secondary Outcomes (4)

• Comparison of subjective sleep quality during oxygen therapy and room air after a period of 6 weeks by means of 4 validated sleep questionnaires

  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).

  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

  after a 6 weeks period

• Comparison of a possible arterial pulmonary hypertension during oxygen therapy and room air after a period of 6 weeks by means of an echocardiography

  after a 6 weeks period

Study Arms (2)

Air - oxygen

OTHER

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

Oxygen - Air

OTHER

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

Interventions

Air - oxygen OTHER

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%.

Air - oxygen

Oxygen - Air OTHER

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%.

Oxygen - Air

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Vaincre la Mucoviscidose: collaborator

Study Sites (1)

Service de pneumologie pédiatrique, Hôpital Armand Trousseau

Paris, 75012, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Brigitte FAUROUX, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: April 27, 2012
• Study Start: October 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: June 15, 2015

Record last verified: 2015-06

Locations

FR (1)