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

This study has been completed.
Sponsor:
Collaborator:
INO Therapeutics
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00748423
First received: September 5, 2008
Last updated: August 1, 2013
Last verified: July 2013

September 5, 2008
August 1, 2013
December 2008
December 2012   (final data collection date for primary outcome measure)
Percentage of patients with treatment failure [ Time Frame: at day 3 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00748423 on ClinicalTrials.gov Archive Site
  • Proportion of hypoxemic patients defined by a PaO2/FiO2 ratio < 300 [ Time Frame: at day 3 ] [ Designated as safety issue: Yes ]
  • Variation of pulmonary arterial systolic pressure evaluated by echocardiography [ Time Frame: at day 1, day 3 and end of study ] [ Designated as safety issue: Yes ]
  • Length of hospitalisation [ Time Frame: from day 0 to day 15 (max) ] [ Designated as safety issue: Yes ]
  • Pain assessment and the cumulative dose of parenteral opioids per body weight [ Time Frame: during the first three days and during entire hospitalization ] [ Designated as safety issue: Yes ]
  • Proportion of patients requiring transfusion therapy (simple or exchange) [ Time Frame: from day 1 to end of study ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Inhaled Nitric Oxide in Acute Chest Syndrome (INOSTA Study)
Bicentric Study of the Effect of Inhaled Nitric Oxide Compared to Placebo in Acute Chest Syndrome of Adult Sickle Cell Patients

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.

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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Sickle Cell Disease
  • Acute Chest Syndrome
  • Drug: Nitric Oxide
    NO in inhalation for 3 days
    Other Name: Nitric Oxide
  • Drug: Placebo
    Placebo in inhalation for 3 days
    Other Name: "Nitrogen" placebo
  • Experimental: 1
    Nitric Oxide in nitrogen
    Intervention: Drug: Nitric Oxide
  • Placebo Comparator: 2
    Nitrogen
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00748423
P060701
Yes
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
INO Therapeutics
Principal Investigator: MAITRE Bernard, MD, PHD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP