Voriconazole Inhalation Powder for the Treatment of Pulmonary Aspergillosis

November 18, 2024 updated by: TFF Pharmaceuticals, Inc.

Use of Voriconazole Inhalation Powder for the Treatment of Pulmonary Aspergillosis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
No longer available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Expanded Access Type

Expanded Access Type

Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
  • Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
  • Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
  • Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
  • Intermediate-size Population

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

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 Bronchopulmonary Aspergillosis (ABPA), Aspergillus tracheobronchitis and Aspergillus bronchial anastomotic infection. Pulmonary infections with voriconazole sensitive fungi other than Aspergillus such as but not limited to scedosporium and fusarium are also allowed.
  3. Patient has limited or no treatment options due to documented or anticipated intolerance, toxicity, contraindications, or lack of clinical response to SOC antifungal therapy, as advocated by the relevant regional treatment guidelines.
  4. The treating clinician considers that the potential advantage of using Voriconazole Inhalation Powder outweighs the potential risks. In patients with disseminated fungal infection in addition to pulmonary infection, Voriconazole Inhalation Powder must be used as add-on therapy to the current SOC.
  5. The Sponsor agrees that the benefit:risk assessment is favorable for the use of Voriconazole Inhalation Powder in the patient.
  6. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at Screening (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 birth control 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 treatment duration in the opinion of the treating clinician or designee.
  8. Patient provides informed consent and agrees to follow the treatment regimen and safety and outcomes assessments.

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 or excipients 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 of Voriconazole Inhalation Powder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TFF Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 31, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TFF-VE-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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