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Effect of Inhaled Nitric Oxide in Acute Chest Syndrome (INOSTA Study) (INOSTA)

Primary Purpose

Sickle Cell Disease, Acute Chest Syndrome

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Nitric Oxide
Placebo
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Disease focused on measuring Inhaled drug, Acute lung injury, Nitric oxide, Sickle cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with sickle cell disease (Hemoglobin genotypes characterized by standard procedures as homozygous hemoglobin SS, hemoglobin SC, and S beta thalassemia)
  • Diagnosis of acute chest syndrome based on the presence of fever, dyspnea or chest pain, associated with new pulmonary infiltrates on chest X-ray

Exclusion Criteria:

  • Patient has been hospitalised < 14 days ago
  • Patients presenting with clinically diagnosed bacterial infections
  • Patients who have received an exchange transfusion in the last 30 days or are in a transfusion program.
  • Current pregnancy or lactation
  • Patient who is currently enrolled in any other investigational drug study
  • Previous participation in this study

  • Any of the following medical conditions:

    • Immediate need of ventilatory support wih orotracheal intubation
    • Hemodynamic instability

Sites / Locations

  • Réanimation Médicale, Hôpital A Chenevier-H Mondor

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Nitric Oxide in nitrogen

Nitrogen

Outcomes

Primary Outcome Measures

Percentage of patients with treatment failure

Secondary Outcome Measures

Proportion of hypoxemic patients defined by a PaO2/FiO2 ratio < 300
Variation of pulmonary arterial systolic pressure evaluated by echocardiography
Length of hospitalisation
Pain assessment and the cumulative dose of parenteral opioids per body weight
Proportion of patients requiring transfusion therapy (simple or exchange)

Full Information

First Posted
September 5, 2008
Last Updated
August 1, 2013
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Mallinckrodt
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1. Study Identification

Unique Protocol Identification Number
NCT00748423
Brief Title
Effect of Inhaled Nitric Oxide in Acute Chest Syndrome (INOSTA Study)
Acronym
INOSTA
Official Title
Bicentric Study of the Effect of Inhaled Nitric Oxide Compared to Placebo in Acute Chest Syndrome of Adult Sickle Cell Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Mallinckrodt

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Acute chest syndrome (ACS) is a frequent and potentially life-threatening pulmonary illness. It is a complication of sickle cell disease and is the leading cause of death from this disease in adults. Several pathologic processes are recognized causes of ACS, including infectious diseases, hypoventilation secondary to chest pain, in situ thrombosis and pulmonary fat embolism. Inhaled nitric oxide (iNO) has been shown to be a pulmonary vasodilatator with minimal systemic effects and has also been shown to improve gas exchange in both animal and human acute lung injury (ALI). The combined effects of iNO gas of improving pulmonary ventilation to perfusion matching, reducing alveolar and systemic inflammation, modulate the course of acute chest syndrome, which combine the physiopathology of vaso-occlusive crisis and acute lung injury. We hypothesise inhaled NO will improve oxygenation and clinical outcome of sickle cell disease patients with acute chest syndrome.
Detailed Description
Objectives: To compare the outcome and duration of acute chest syndrome (ACS) in patients with sickle cell disease (SCD) treated with iNO to that of similar episodes experienced by patients which receive a placebo. Study design: Bi-center, prospective, randomized, controlled clinical trial Enrollment: 24 months Patients will be treated for 72 hours Patients will be followed for 15 days or until discharged home Sample size: The study will accrue a maximum of 240 patients Progress of the trial will be reviewed by an independent data and safety monitoring committee to determine if randomization should stop for safety reasons.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Acute Chest Syndrome
Keywords
Inhaled drug, Acute lung injury, Nitric oxide, Sickle cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Nitric Oxide in nitrogen
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Nitrogen
Intervention Type
Drug
Intervention Name(s)
Nitric Oxide
Intervention Description
NO in inhalation for 3 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
"Nitrogen" placebo
Intervention Description
Placebo in inhalation for 3 days
Primary Outcome Measure Information:
Title
Percentage of patients with treatment failure
Time Frame
at day 3
Secondary Outcome Measure Information:
Title
Proportion of hypoxemic patients defined by a PaO2/FiO2 ratio < 300
Time Frame
at day 3
Title
Variation of pulmonary arterial systolic pressure evaluated by echocardiography
Time Frame
at day 1, day 3 and end of study
Title
Length of hospitalisation
Time Frame
from day 0 to day 15 (max)
Title
Pain assessment and the cumulative dose of parenteral opioids per body weight
Time Frame
during the first three days and during entire hospitalization
Title
Proportion of patients requiring transfusion therapy (simple or exchange)
Time Frame
from day 1 to end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with sickle cell disease (Hemoglobin genotypes characterized by standard procedures as homozygous hemoglobin SS, hemoglobin SC, and S beta thalassemia) Diagnosis of acute chest syndrome based on the presence of fever, dyspnea or chest pain, associated with new pulmonary infiltrates on chest X-ray Exclusion Criteria: Patient has been hospitalised < 14 days ago Patients presenting with clinically diagnosed bacterial infections Patients who have received an exchange transfusion in the last 30 days or are in a transfusion program. Current pregnancy or lactation Patient who is currently enrolled in any other investigational drug study Previous participation in this study Any of the following medical conditions: Immediate need of ventilatory support wih orotracheal intubation Hemodynamic instability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MAITRE Bernard, MD, PHD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Réanimation Médicale, Hôpital A Chenevier-H Mondor
City
Creteil
ZIP/Postal Code
94 000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26431718
Citation
Maitre B, Djibre M, Katsahian S, Habibi A, Stankovic Stojanovic K, Khellaf M, Bourgeon I, Lionnet F, Charles-Nelson A, Brochard L, Lemaire F, Galacteros F, Brun-Buisson C, Fartoukh M, Mekontso Dessap A. Inhaled nitric oxide for acute chest syndrome in adult sickle cell patients: a randomized controlled study. Intensive Care Med. 2015 Dec;41(12):2121-9. doi: 10.1007/s00134-015-4060-2. Epub 2015 Oct 2.
Results Reference
derived

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Effect of Inhaled Nitric Oxide in Acute Chest Syndrome (INOSTA Study)

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