Trials / No Longer Available
No Longer AvailableNCT05897294
Voriconazole Inhalation Powder for the Treatment of Pulmonary Aspergillosis
Use of Voriconazole Inhalation Powder for the Treatment of Pulmonary Aspergillosis
- Status
- No Longer Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- TFF Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
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.
Detailed 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).
Conditions
- Invasive Pulmonary Aspergillosis
- Allergic Bronchopulmonary Aspergillosis
- Chronic Pulmonary Aspergillosis
- Aspergillus Tracheobronchitis
- Anastomotic Infection
- Pulmonary Fungal Infection
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Voriconazole Inhalation Powder | dry powder inhalation of voriconazole |
Timeline
- First posted
- 2023-06-09
- Last updated
- 2024-11-21
Source: ClinicalTrials.gov record NCT05897294. Inclusion in this directory is not an endorsement.