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

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ClinicalTrials.gov Identifier: NCT00748423
Recruitment Status : Completed
First Posted : September 8, 2008
Last Update Posted : August 2, 2013
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Acute Chest Syndrome Drug: Nitric Oxide Drug: Placebo Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Bicentric Study of the Effect of Inhaled Nitric Oxide Compared to Placebo in Acute Chest Syndrome of Adult Sickle Cell Patients
Study Start Date : December 2008
Primary Completion Date : December 2012
Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: 1
Nitric Oxide in nitrogen
Drug: Nitric Oxide
NO in inhalation for 3 days
Placebo Comparator: 2
Drug: Placebo
Placebo in inhalation for 3 days
Other Name: "Nitrogen" placebo

Primary Outcome Measures :
  1. Percentage of patients with treatment failure [ Time Frame: at day 3 ]

Secondary Outcome Measures :
  1. Proportion of hypoxemic patients defined by a PaO2/FiO2 ratio < 300 [ Time Frame: at day 3 ]
  2. Variation of pulmonary arterial systolic pressure evaluated by echocardiography [ Time Frame: at day 1, day 3 and end of study ]
  3. Length of hospitalisation [ Time Frame: from day 0 to day 15 (max) ]
  4. Pain assessment and the cumulative dose of parenteral opioids per body weight [ Time Frame: during the first three days and during entire hospitalization ]
  5. Proportion of patients requiring transfusion therapy (simple or exchange) [ Time Frame: from day 1 to end of study ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00748423

Réanimation Médicale, Hôpital A Chenevier-H Mondor
Creteil, France, 94 000
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: MAITRE Bernard, MD, PHD Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00748423     History of Changes
Other Study ID Numbers: P060701
First Posted: September 8, 2008    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: July 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Inhaled drug
Acute lung injury
Nitric oxide
Sickle cell

Additional relevant MeSH terms:
Nitric Oxide
Anemia, Sickle Cell
Acute Chest Syndrome
Pathologic Processes
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents