AIT’s application for the treatment of bronchiolitis (RSV) in infants.
Bronchiolitis is the most common acute lower respiratory infection in infants, and is the leading cause of infant hospitalizations during the first year of life. It is viral, primarily caused by the Respiratory Syncytial Virus (RSV). Nitric Oxide has been found to be effective against several microbial and viral strains involved in severe lung pathologies, suggesting that it may be effective in the treatment of virus-induced disease such as Bronchiolitis.
Our NOxBR application is based on proprietary technology that utilizes inhalations of nitric oxide for several consecutive days until elimination of the disease. NOxBR was successful in a Phase II clinical study. We are currently in preparation for phase IIIa clinical trials for NOxBR.
About Bronchiolitis (RSV)
Bronchiolitis is a viral lower respiratory tract infection, caused mainly by Respiratory Syncitial Virus, affecting mainly young infants.
The initial symptoms of bronchiolitis are similar to that of a common cold, but the illness leads to cough, wheezing, and respiratory complications. Treatment is mainly supportive, including oxygen administration, hydration, nasal suctioning. The use of other pharmacological therapies such as bronchodilators is controversial
Each year 150 million new cases of bronchiolitis are reported worldwide in infants; 2% to 3% require hospitalization. In the United States, there are approximately 150,000 bronchiolitis-related hospitalizations annually among children younger than age 5, of which about 115,000 are under the age of 1.
These hospital visits result in total hospital charges of $1.7 billion in 2009, according to a study published in 2013. For infants, bronchiolitis accounts for 20% of annual hospitalizations and 18% of emergency department visits. The mortality in children less than one year of age was 0.25%.
In 2009, the total direct cost of bronchiolitis related hospitalizations was $545 million.
Limitations of Current Treatment Options for Bronchiolitis
Clinical practice in the management of acute bronchiolitis varies widely. There is much controversy, confusion and lack of evidence concerning the best treatment option. Disease management mainly consists of supportive care: oxygen supplementation hydration and naso-pharyngeal suction. Using other treatments such as inhalations of hypertonic saline, inhaled beta-agonist drugs, and corticosteroids is controversial.
None of the specified treatments has been proven to have a clear beneficial effect on the course of the disease or a reduction in the length of hospitalization. In addition, some treatment strategies have been subject to debate regarding efficacy, safety and cost.
The Respiratory Syncytial Virus (RSV) is the most common cause and is responsible for more than 80% of cases. However, several other viruses that cause cold-like symptoms can also cause bronchiolitis. RSV occurs in epidemics every winter. The virus is found in the infected person’s nasal secretions. It is spread by an infected person who sneezes or coughs less than 3 feet away from someone else. It can also be transmitted by touching contaminated toys and then touching one’s nose or eyes.
People do not develop permanent immunity to the virus, which means that they can be infected by it many times.
The early symptoms are similar to a common cold. The first symptom is often a congested or runny nose, sometimes accompanied by a cough or a slightly high temperature.
In addition, infants with a more severe bronchiolitis may exhibit four symptoms:
- A distinctive rasping cough – the most significant symptom
- Shallow, quick breaths not taking in much air
- Low appetite
Bronchiolitis can easily spread from one person to another. Children should be kept home until they are healthy to prevent passing the infection to others.
There is no vaccine to prevent bronchiolitis. However, a passive immunization is available, that may lessen the risk of infection by Respiratory Syncytial Virus. This monthly immunization is given only to preterm babies. Proper hand washing habits can help to prevent the spread of illness.
Yes. It is well known for years, that infants who suffered from RSV bronchiolitis during the first year of life are at risk to experience recurrent episodes of breathing difficulties as well as wheezing and develop asthma during early childhood. Recent research indicate that prevention of RSV lower-respiratory tract infection may represent an important and promising strategy in primary prevention of asthma.