Voriconazole Inhalation Powder for the Treatment of Pulmonary Aspergillosis

Last updated: November 18, 2024
Sponsor: TFF Pharmaceuticals, Inc.
Overall Status: Trial Not Available

Phase

N/A

Condition

Aspergillosis

Treatment

Voriconazole Inhalation Powder

Clinical Study ID

NCT05897294
TFF-VE-001
  • Ages > 18
  • All Genders

Study Summary

Voriconazole Inhalation Powder is available on an expanded access basis to patients with pulmonary aspergillosis for up to 12 weeks. Duration of treatment may be extended on a case-by-case basis depending on drug availability and after discussion with the Sponsor.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female aged 18 years or older at screening.

  2. Diagnosed with pulmonary aspergillosis including Invasive Pulmonary Aspergillosis (IPA), Chronic Pulmonary Aspergillosis (CPA), Allergic BronchopulmonaryAspergillosis (ABPA), Aspergillus tracheobronchitis and Aspergillus bronchialanastomotic infection. Pulmonary infections with voriconazole sensitive fungi otherthan Aspergillus such as but not limited to scedosporium and fusarium are alsoallowed.

  3. Patient has limited or no treatment options due to documented or anticipatedintolerance, toxicity, contraindications, or lack of clinical response to SOCantifungal therapy, as advocated by the relevant regional treatment guidelines.

  4. The treating clinician considers that the potential advantage of using VoriconazoleInhalation Powder outweighs the potential risks. In patients with disseminatedfungal infection in addition to pulmonary infection, Voriconazole Inhalation Powdermust be used as add-on therapy to the current SOC.

  5. The Sponsor agrees that the benefit:risk assessment is favorable for the use ofVoriconazole Inhalation Powder in the patient.

  6. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test atScreening (Visit 1) and a negative urine pregnancy test (UPT) prior to first dose.Sexually active WOCBP and male patients must agree to use highly effective birthcontrol or abstinence until 3 months after last dose.

  7. Patient succeeds in meeting training criteria on the use of the dry powder inhaler (DPI) and is willing and able to perform adequate inhalation technique for treatmentduration in the opinion of the treating clinician or designee.

  8. Patient provides informed consent and agrees to follow the treatment regimen andsafety and outcomes assessments.

Exclusion

Exclusion Criteria:

  1. Infection with fungi not responsive to voriconazole.

  2. Pregnant or breastfeeding.

  3. History or presence of hypersensitivity or idiosyncratic reaction to voriconazole orexcipients in Voriconazole Inhalation Powder.

  4. Patients with severe liver disease as defined by Child-Pugh Class C.

  5. Patients who are eligible and are able to participate in a clinical trial ofVoriconazole Inhalation Powder.

Study Design

Treatment Group(s): 1
Primary Treatment: Voriconazole Inhalation Powder
Phase:
Study Start date:
Estimated Completion Date:

Study Description

The purpose of this expanded access protocol is to provide, upon the treating clinician's request and Sponsor assessment, Voriconazole Inhalation Powder to patients with pulmonary aspergillosis, or patients with other voriconazole-sensitive pulmonary fungal infections, who have limited or no other treatment options or who have had unfavorable response to adequate standard of care antifungal therapy including to oral or intravenous voriconazole.

Reporting of serious adverse events (SAE) and Adverse Events of Special Interest (AESI) are required under this expanded access protocol. Patient treatment and outcomes information are also intended to be gathered under this protocol to the extent feasible (e.g., disease progression/improvement after treatment).