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

NCT00748423 | Completed Phase 2 DMC

• 1 other identifier: P060701
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease; Acute Chest Syndrome

Keywords

Inhaled drug; Acute lung injury; Nitric oxide; Sickle cell

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with treatment failure

  at day 3

Secondary Outcomes (5)

• Proportion of hypoxemic patients defined by a PaO2/FiO2 ratio < 300

  at day 3

• Variation of pulmonary arterial systolic pressure evaluated by echocardiography

  at day 1, day 3 and end of study

• Length of hospitalisation

  from day 0 to day 15 (max)

• Pain assessment and the cumulative dose of parenteral opioids per body weight

  during the first three days and during entire hospitalization

• Proportion of patients requiring transfusion therapy (simple or exchange)

  from day 1 to end of study

Study Arms (2)

1

EXPERIMENTAL

Nitric Oxide in nitrogen

Drug: Nitric Oxide

2

PLACEBO COMPARATOR

Nitrogen

Drug: Placebo

Interventions

Nitric Oxide DRUG

NO in inhalation for 3 days

1

Placebo DRUG

Placebo in inhalation for 3 days

Also known as: "Nitrogen" placebo

2

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Mallinckrodt: collaborator

Study Sites (1)

Réanimation Médicale, Hôpital A Chenevier-H Mondor

Créteil, 94 000, France

Location

Related Publications (1)

• 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.

  PMID: 26431718 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell; Acute Chest Syndrome; Acute Lung Injury

Interventions

Nitric Oxide

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Injury

Intervention Hierarchy (Ancestors)

Reactive Nitrogen Species; Free Radicals; Inorganic Chemicals; Nitrogen Oxides; Nitrogen Compounds; Oxides; Oxygen Compounds; Organic Chemicals

Study Officials

• MAITRE Bernard, MD, PHD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 8, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 2, 2013

Record last verified: 2013-07

Locations

FR (1)