(NIH.gov)
21 Nov. 2018. Results from a clinical trial show an inhaled form of a current anti-fungal drug to treat a complication of asthma is safe for patients, including those with asthma. Findings from the trial, testing the drug Pulmazole made by Pulmatrix Inc. in Lexington, Massachusetts, were presented on 17 November at the annual meeting of the American College of Allergy, Asthma, and Immunology in Seattle.
Pulmazole is designed to treat fungal infections from allergic bronchopulmonary aspergillosis, or ABPA, an allergic hypersensitivity to the fungus Aspergillus fumigatus occurring most often among people with asthma, but also cystic fibrosis. Asthma is chronic condition, where the airways become inflamed and narrow, causing wheezing, shortness of breath, tightness in the chest, and coughing for periods of time. Among asthma’s underlying causes are infections, pollutants in the air, and allergies to pollen, molds, fungi, or dust mites that trigger airway inflammation.
Pulmatrix develops inhaled medications to treat serious respiratory disorders, including asthma. The company’s technology, called iSperse, — short for inhaled small particles easily respirable and emitted — creates dry particles that the company says overcome a serious problem with current dry-powder inhalers, namely the sticking of medication particles in the mouth and throat, which limits delivery of drugs into the lungs where they’re needed. The powder particles are smaller, denser, and milled to be more aerodynamic to avoid being deposited in the mouth or throat.
Pulmazole is an inhaled version of the anti-fungal drug itraconazole usually given in pill, capsule, or liquid form to treat ABPA and other fungal disorders. The company says itraconazole does not always respond consistently in the body and can result in adverse side effects, particularly when reacting to other drugs. Because Pulmazole is taken directly into the lungs, it can be administered in lower doses than the systemic drug itraconazole.
The early-stage clinical trial tested Pulmazole among 58 individuals, including 17 participants with mild to moderate asthma. The 41 healthy adult volunteers were divided into 2 groups testing the safety of Pulmazole in single and multiple doses of 5 to 35 milligrams, looking primarily for adverse effects. The research team also assessed the extent of itraconazole from Pulmazole in the blood of the healthy volunteers, since the drug is designed for use only in the lungs, and extension of the drug into the blood stream would be a sign that the drug does not stay strictly on target.
Among the 17 individuals with asthma, the researchers also looked for adverse effects from Pulmazole and its evidence of activity in the body. Participants with asthma were randomly assigned to receive inhaled Pulmazole in single doses of 20 milligrams or a 200 milligram dose of itraconazole solution. After 2 weeks, the treatments were reversed among asthma participants, who were then given the alternate treatment: Pulmazole or itraconazole solution.
The results show the inhaled Pulmazole was safe and well tolerated among both the healthy participants and those with asthma. The only adverse effects were mild coughing after inhaling the drug’s powder, which usually disappeared in a few seconds. No serious adverse effects were reported and none of those enrolled in the trial discontinued their participation. Blood tests from the healthy volunteers showed very low concentrations of itraconazole in their blood, indicating the drug was largely absorbed by lung tissue.
Among participants with asthma, those receiving inhaled Pulmazole had 66 times less itraconazole in their blood than recipients of the conventional itraconazole solution. Yet, individuals inhaling Pulmazole had about 70 times higher concentration of itraconazole in their sputum (lung and airway mucus and saliva) than recipients of the itraconazole solution.
Pulmatrix says the results support beginning a mid-stage trial of Pulmazole among individuals with asthma and ABPA, as soon as next month.
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