CLINICAL TRIALS PROFILE FOR INOMAX

All Clinical Trials for Inomax

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00041548 ↗	Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation	Terminated	Mallinckrodt	Phase 1/Phase 2	2002-05-01	The purpose of this pilot study is to evaluate whether administration of nitric oxide (NO)gas by oxygen hood at 20 ppm significantly increases PaO2, as compared to placebo gas (oxygen), within one hour of initiation and with no significant adverse effects.
NCT00041574 ↗	Hospital-Based Program for Treatment of Severe Cardiopulmonary Disease With Inhaled Nitric Oxide	Terminated	Mallinckrodt	Phase 2	2002-04-01	The purpose of this program is to evaluate the logistic issues and patient requirements for chronic pulsed INOmax delivery in ambulatory, home-care patients. To understand patient needs, patients with a variety of underlying diseases will be included. Safety of chronic therapy will be monitored by serial measurements of methemoglobin, platelet function assay and reported adverse events.
NCT00060840 ↗	The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation	Completed	Mallinckrodt	Phase 2	2003-07-01	The purpose of this study is to assess the utility of nitric oxide for inhalation during left ventricular assist device (LVAD) implantation following cardiopulmonary bypass (CPB). This is to be assessed by the number of patients in each treatment group meeting failure criteria within 24 hours on study drug, as defined by two or more of the following: - Left ventricular flow rate index (LVFRI) ≤ 2.0 L/min/m^2 - Administration of ≥ 20 inotropic equivalents (IE) - 10 µg/kg/min dopamine, dobutamine, enoximone or amrinone is equivalent to 10 IE - 0.1 µg/kg/min epinephrine or norepinephrine is equivalent to 10 IE - 1 µg/kg/min milrinone is equivalent to 15 IE - 0.1 U/min vasopressin is equivalent to 10 IE - Mean arterial pressure (MAP) ≤ 55 mmHg - Central venous pressure (CVP) ≥ 16 mmHg - Percent mixed venous oxygen saturation (SvO2) ≤ 55% Or at least one of the following criteria: - Failure to wean from cardiopulmonary bypass at least once due to hemodynamic failure. Re-initiation of cardiopulmonary bypass to correct bleeding or other technical issues will not be considere 'failure to wean' - Death
NCT00094887 ↗	Nitric Oxide Inhalation to Treat Sickle Cell Pain Crises	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	2004-10-01	This study will examine whether nitric oxide (NO) gas can reduce the time it takes for pain to go away in patients who are in sickle cell crisis. NO is important in regulating blood vessel dilation, and consequently, blood flow. The gas is continuously produced by cells that line the blood vessels. It is also transported from the lungs by hemoglobin in red blood cells. Patients 10 years of age or older with sickle cell disease (known SS, S-beta-thalassemia or other blood problems causing sickle cell disease) may be eligible for this study. Patients whose disease is due to hemoglobin (Hgb) SC are excluded. Candidates are screened with blood tests and a chest x-ray to look at the lungs and heart. Participants are admitted to the hospital in a pain crisis. They are evaluated and then randomly assigned to receive one of two treatments: 1) standard treatment plus NO, or 2) standard treatment plus placebo. The placebo used in this study is nitrogen, a gas that makes up most of the air we breathe and is not known to help in sickle cell disease. For the first 8 hours of the study, patients receive placebo or NO through a facemask. The mask may be taken off for 5 minutes every hour and for not more than 20 minutes to eat a meal. After the first 8 hours, the gas is delivered through a nasal cannula (small plastic tubing that rests under the nose) that may be taken off only while showering or using the restroom. Patients are questioned about the severity of their pain when they start the study and then every few hours while they are in the hospital. Their vital signs (temperature, breathing rate, and blood pressure) and medicines are checked. Patients will breathe the gas for a maximum of 3 days, but will stay hospitalized until the patient feels well enough to go home. Patients are followed up about 1 month after starting the study by a return visit to the hospital or by a phone call.
NCT00094887 ↗	Nitric Oxide Inhalation to Treat Sickle Cell Pain Crises	Completed	Mallinckrodt	Phase 2	2004-10-01	This study will examine whether nitric oxide (NO) gas can reduce the time it takes for pain to go away in patients who are in sickle cell crisis. NO is important in regulating blood vessel dilation, and consequently, blood flow. The gas is continuously produced by cells that line the blood vessels. It is also transported from the lungs by hemoglobin in red blood cells. Patients 10 years of age or older with sickle cell disease (known SS, S-beta-thalassemia or other blood problems causing sickle cell disease) may be eligible for this study. Patients whose disease is due to hemoglobin (Hgb) SC are excluded. Candidates are screened with blood tests and a chest x-ray to look at the lungs and heart. Participants are admitted to the hospital in a pain crisis. They are evaluated and then randomly assigned to receive one of two treatments: 1) standard treatment plus NO, or 2) standard treatment plus placebo. The placebo used in this study is nitrogen, a gas that makes up most of the air we breathe and is not known to help in sickle cell disease. For the first 8 hours of the study, patients receive placebo or NO through a facemask. The mask may be taken off for 5 minutes every hour and for not more than 20 minutes to eat a meal. After the first 8 hours, the gas is delivered through a nasal cannula (small plastic tubing that rests under the nose) that may be taken off only while showering or using the restroom. Patients are questioned about the severity of their pain when they start the study and then every few hours while they are in the hospital. Their vital signs (temperature, breathing rate, and blood pressure) and medicines are checked. Patients will breathe the gas for a maximum of 3 days, but will stay hospitalized until the patient feels well enough to go home. Patients are followed up about 1 month after starting the study by a return visit to the hospital or by a phone call.

Clinical Trial Conditions for Inomax

Condition Name

Condition Name for Inomax
Intervention	Trials
Lung Disease	2
Sickle Cell Disease	2
Heart Failure	1
Persistent Pulmonary Hypertension of Newborn	1

Condition MeSH

Condition MeSH for Inomax
Intervention	Trials
Hypertension, Pulmonary	3
Anemia, Sickle Cell	3
Respiratory Insufficiency	2
Hypertension	2

Clinical Trial Locations for Inomax

Trials by Country

Trials by Country for Inomax
Location	Trials
United States	44
Canada	3
Germany	2
Belgium	1
United Kingdom	1

Trials by US State

Trials by US State for Inomax
Location	Trials
California	4
Colorado	3
Ohio	3
New Jersey	3
Alabama	2

Clinical Trial Progress for Inomax

Clinical Trial Phase

Clinical Trial Phase for Inomax
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Inomax
Clinical Trial Phase	Trials
Completed	7
Terminated	4
Withdrawn	2

Clinical Trial Sponsors for Inomax

Sponsor Name

Sponsor Name for Inomax
Sponsor	Trials
Mallinckrodt	11
University of California, Los Angeles	1
National Heart, Lung, and Blood Institute (NHLBI)	1

Sponsor Type

Sponsor Type for Inomax
Sponsor	Trials
Industry	11
Other	10
NIH	2

Inhaled Nitric Oxide: Clinical Trials, Market Analysis, and Projections for INOmax

Introduction to INOmax

INOmax, a formulation of nitric oxide for inhalation, is a vasodilator used in conjunction with ventilatory support and other appropriate agents. It is primarily indicated for the treatment of term and near-term neonates with hypoxic respiratory failure, including conditions such as pulmonary hypertension and neonatal respiratory distress syndrome (RDS)[4].

Clinical Trials Overview

Efficacy and Safety

Clinical trials for INOmax have been extensive, involving several studies to evaluate its efficacy and safety.

• NINOS and CINRGI Studies: These studies included 325 patients on INOmax doses of 5 to 80 ppm and 251 patients on placebo. The results showed that total mortality was 9% on INOmax and 11% on placebo, indicating that INOmax did not increase mortality rates significantly. The duration of hospitalization and the incidence of severe adverse events such as intracranial hemorrhage, cerebral infarction, and pulmonary hemorrhage were similar in both the INOmax and placebo groups[1][3][4].

• ECMO Reduction: A key finding from the CINRGI study was that significantly fewer neonates in the INOmax group required extracorporeal membrane oxygenation (ECMO) compared to the control group (31% vs. 57%, p<0.001). This study also demonstrated improved oxygenation in the INOmax group as measured by PaO2, OI, and alveolar-arterial gradient[4].

• Adverse Reactions: Common adverse reactions reported in clinical trials included hypotension, withdrawal, atelectasis, and hematuria. However, these reactions were not statistically significant when compared to the placebo group. Post-marketing reports have also identified adverse reactions such as dose errors associated with the delivery system, headaches, and other symptoms, although these are less frequent and not always causally linked to INOmax[3][4].

Specific Clinical Outcomes

• Prevention of Bronchopulmonary Dysplasia (BPD): Four large, multi-center, double-blind, placebo-controlled clinical trials involving 2,600 preterm infants did not establish efficacy for the prevention of BPD. However, these studies did show that INOmax improved oxygenation and reduced the need for ECMO in neonates with hypoxic respiratory failure[3].

• Adult Respiratory Distress Syndrome (ARDS): INOmax has been found ineffective in reducing mortality or improving outcomes in adult patients with ARDS in clinical trials[3].

Market Analysis

Current Market Size and Growth

The global inhaled nitric oxide delivery systems market, which includes INOmax, was valued at approximately USD 254.4 million in 2023. This market is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.4% from 2022 to 2031, reaching a valuation of USD 497.4 million by 2031[2].

Key Drivers

• Increasing Prevalence of Respiratory Conditions: The rising incidence of respiratory diseases such as neonatal RDS, chronic obstructive pulmonary disease (COPD), pulmonary hypertension, and ARDS is driving the demand for inhaled nitric oxide therapy[2][5].

• Advancements in Medical Technology: The development of portable and user-friendly delivery systems, such as Vero Biotech's iNOvent, has made inhaled nitric oxide therapy more accessible and convenient for patients[2].

• Healthcare Expenditure and Awareness: Increased healthcare spending and growing awareness about the benefits of inhaled nitric oxide therapy are also contributing to market growth[2][5].

Market Segmentation

• Type: The market is segmented into pediatric and adult segments. The pediatric segment is currently dominant due to the high incidence of neonatal respiratory conditions, while the adult segment is growing due to increasing awareness and clinical trials exploring its efficacy in adult respiratory conditions[2][5].

• Application: Key applications include hypoxemic respiratory failure treatment, acute vasoreactivity testing, and pulmonary hypertension treatment. The hypoxic respiratory failure segment is the most significant due to the effectiveness of inhaled nitric oxide in treating neonatal conditions[2].

• End-user: Hospitals and ambulatory surgical centers are the primary end-users, with hospitals being the largest segment due to the intensive care requirements for patients receiving inhaled nitric oxide therapy[2].

• Region: North America and Europe are significant markets, but the Asia Pacific region is expected to capture a substantial market share in the coming years due to its large population and increasing healthcare expenditure[2].

Key Players

• Mallinckrodt Pharmaceuticals: Known for manufacturing INOmax, a widely used inhaled nitric oxide therapy system for neonates with hypoxic respiratory failure[2].

• Bellerophon Therapeutics: Develops the INOpulse system, which delivers inhaled nitric oxide for treating pulmonary arterial hypertension (PAH) and other pulmonary diseases[2].

• Vero Biotech: Developed the portable iNOvent delivery system, designed for use in various clinical settings including neonatal and pediatric care[2].

Market Projections

Regional Growth

• The Asia Pacific region is anticipated to exhibit substantial growth due to its large population, increasing healthcare expenditure, and efforts by governments and healthcare organizations to improve access to inhaled nitric oxide delivery systems[2].

Technological Advancements

• The market is expected to benefit from ongoing advancements in medical technology, including the development of more portable and user-friendly delivery systems. These innovations will make inhaled nitric oxide therapy more accessible and convenient for a broader range of patients[2][5].

Expanding Therapeutic Applications

• Ongoing clinical trials and research are expected to expand the therapeutic applications of inhaled nitric oxide, further boosting market growth. This includes exploring its efficacy in treating other adult respiratory conditions beyond current indications[2][5].

Key Takeaways

• INOmax has demonstrated efficacy in reducing the need for ECMO and improving oxygenation in neonates with hypoxic respiratory failure.
• The global inhaled nitric oxide delivery systems market is projected to grow significantly, driven by increasing prevalence of respiratory diseases and advancements in medical technology.
• Key players are investing in research and development to expand the applications and accessibility of inhaled nitric oxide therapy.
• The Asia Pacific region is expected to be a significant growth area due to its large population and increasing healthcare expenditure.

FAQs

What is INOmax used for?

INOmax is used for the treatment of term and near-term neonates with hypoxic respiratory failure, including conditions such as pulmonary hypertension and neonatal respiratory distress syndrome (RDS)[4].

What are the common adverse reactions associated with INOmax?

Common adverse reactions include hypotension, withdrawal, atelectasis, and hematuria. However, these reactions are generally not statistically significant when compared to placebo groups[3][4].

Which companies are key players in the inhaled nitric oxide delivery system market?

Key players include Mallinckrodt Pharmaceuticals, Bellerophon Therapeutics, and Vero Biotech, each contributing to the development and commercialization of inhaled nitric oxide delivery systems[2].

What is the projected growth rate of the global inhaled nitric oxide delivery systems market?

The market is projected to grow at a CAGR of 5.4% from 2022 to 2031, reaching a valuation of USD 497.4 million by 2031[2].

How does INOmax impact the need for ECMO in neonates?

INOmax has been shown to significantly reduce the need for ECMO in neonates with hypoxic respiratory failure, with a reduction from 57% in the placebo group to 31% in the INOmax group[4].

Sources

1. INOmax nitric oxide for inhalation. FDA.
2. Inhaled Nitric Oxide Delivery System Market Predicted to Reach USD 497.4 million by 2031. GlobeNewswire.
3. INOmax (nitric oxide) gas, for inhalation. FDA.
4. INOmax (nitric oxide) for inhalation. FDA.
5. Inhaled Nitric Oxide Delivery Systems Market Report, 2030. Grand View Research.

Last updated: 2024-12-31