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Safety and Efficacy Study of Nitric Oxide for Inhalation on Chronic Lung Disease in Premature Babies
Phase 3 trial testing Nitric oxide in Lung Disease in 800 participants. Completed in 17 July 2015.
| Lead sponsor | Mallinckrodt |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 800 |
| Start date | 29 May 2005 |
| Primary completion | 16 March 2008 |
| Estimated completion | 17 July 2015 |
| Sites | 35 locations across France, Italy, Finland, Netherlands, Belgium, Sweden, United Kingdom, Germany |
Mallinckrodt — full company profile →
Under 26 Hours, any sex, with Lung Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Survival without BPD is defined as the number of preterm infants of 36 weeks gestational age who survived the treatment period without the need for supplemental oxygen
| Group | Value | 95% CI |
|---|---|---|
| Inhaled Nitric Oxide (INO) | 258 | |
| Placebo | 262 |
Number of participants who died between 2 years and the 7-year Follow-up Period
| Group | Value | 95% CI |
|---|---|---|
| Inhaled Nitric Oxide (INO) | 0 | |
| Placebo | 0 |
The Strengths and Difficulties Questionnaire contained 25 questions that were used to create 5 scales (ranging from 10=most normal to 0=most abnormal) for emotional symptoms, conduct problems, hyperactivity, peer problems, and (10=most abnormal, 0=most normal) for prosocial.
| Group | Value | 95% CI |
|---|---|---|
| Inhaled Nitric Oxide (INO) | 1.9 | ± 1.79 |
| Placebo | 2.1 | ± 1.96 |
| Group | Value | 95% CI |
|---|---|---|
| Inhaled Nitric Oxide (INO) | 1.4 | ± 1.55 |
| Placebo | 1.4 | ± 1.58 |
| Group | Value | 95% CI |
|---|---|---|
| Inhaled Nitric Oxide (INO) | 3.8 | ± 2.64 |
| Placebo | 3.4 | ± 2.66 |
| Group | Value | 95% CI |
|---|---|---|
| Inhaled Nitric Oxide (INO) | 1.2 | ± 1.41 |
| Placebo | 1.5 | ± 1.74 |
| Group | Value | 95% CI |
|---|---|---|
| Inhaled Nitric Oxide (INO) | 8.6 | ± 1.73 |
| Placebo | 8.4 | ± 1.81 |
Time frame: Adverse events (AEs), including clinically significant changes in vital signs, oxygen saturation, and laboratory values, were collected in the safety population for a maximum of 21 days (not during follow-up). All serious AEs are listed, and non-serious treatment-emergent adverse events (TEAEs) are listed if 5% or more participants in any arm experienced any form of that preferred term within 21 days. Survival was counted through the 7-year follow-up, and included under All-cause Mortality.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Inhaled Nitric Oxide (INO) | Placebo |
|---|---|---|---|
| Patent ductus arteriosus | Congenital, familial and genetic disorders | — | — |
| Haemorrhage intracranial | Nervous system disorders | — | — |
| Sepsis | Infections and infestations | — | — |
| Intestinal perforation | Gastrointestinal disorders | — | — |
| Necrotising enterocolitis neonatal | Gastrointestinal disorders | — | — |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | — | — |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | — | — |
| Periventricular leukomalacia | Nervous system disorders | — | — |
| Hydrocephalus | Nervous system disorders | — | — |
| Renal failure | Renal and urinary disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — |
| Neonatal respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | — | — |
| Cardiac arrest | Cardiac disorders | — | — |
| Persistent foetal circulation | Congenital, familial and genetic disorders | — | — |
| Gastrointestinal perforation | Gastrointestinal disorders | — | — |
| Meconium ileus | Gastrointestinal disorders | — | — |
| Infarction | Vascular disorders | — | — |
| Coagulopathy | Blood and lymphatic system disorders | — | — |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Arrhythmia | Cardiac disorders | — | — |
| Bradycardia | Cardiac disorders | — | — |
| Cardiac tamponade | Cardiac disorders | — | — |
| Reaction | System | Inhaled Nitric Oxide (INO) | Placebo |
|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | — | — |
| Patent ductus arteriosus | Congenital, familial and genetic disorders | — | — |
| Hyperbilirubinaemia | Hepatobiliary disorders | — | — |
| Jaundice | Hepatobiliary disorders | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — |
| Apnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Haemorrhage intracranial | Nervous system disorders | — | — |
| Sepsis | Infections and infestations | — | — |
| Hypotension | Vascular disorders | — | — |
| Metabolic acidosis | Metabolism and nutrition disorders | — | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — | — |
| Hyponatraemia | Metabolism and nutrition disorders | — | — |
Most-reported serious reactions: Patent ductus arteriosus, Haemorrhage intracranial, Sepsis, Intestinal perforation, Necrotising enterocolitis neonatal, Pulmonary haemorrhage, Pneumothorax, Periventricular leukomalacia.
Data from ClinicalTrials.gov NCT00551642 adverse events section.
The purpose of this study is to assess the safety and efficacy of inhaled nitric oxide to reduce the risk of chronic lung disease in pre-term infants with respiratory distress, and to assess the long-term effects of the therapy on the development of these children over 7 years of clinical follow-up.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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