NCT00748423

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Sickle Cell Disease
• Acute Chest Syndrome

Interventions

Type	Name	Description
DRUG	Nitric Oxide	NO in inhalation for 3 days
DRUG	Placebo	Placebo in inhalation for 3 days

Timeline

• Start date: 2008-12-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2008-09-08
• Last updated: 2013-08-02

Locations

1 site across 1 country: France