Trial record 12 of 195 for:
Open Studies | "Cystic Fibrosis"
Oxygen Therapy in Cystic Fibrosis (MUCOXY)
This study is currently recruiting participants.
Verified November 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Assistance Publique - Hôpitaux de Paris
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: November 16, 2012
Last verified: November 2012
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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: | June 2014 |
| Estimated Primary Completion Date: | January 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
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
|
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
Contacts
| Contact: Brigitte FAUROUX, MD-PhD | + 33 (0)1 44 73 66 18 | brigitte.fauroux@trs.aphp.fr |
Locations
| France | |
| Service de pneumologie pédiatrique, Hôpital Armand Trousseau | Recruiting |
| Paris, France, 75012 | |
| Contact: Brigitte Fauroux, MD-PhD + 33 (0)1 44 73 66 18) brigitte.fauroux@trs.aphp.fr | |
| Principal Investigator: Brigitte FAUROUX, MD-PhD | |
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: | November 16, 2012 |
| 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 May 23, 2013