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Azole Antifungal

PC945 + Antifungal Therapy for Invasive Pulmonary Aspergillosis

Phase 3
Recruiting
Research Sponsored by Pulmocide Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks (day 84)
Awards & highlights

Study Summary

This trial tests a new treatment for a lung infection that is resistant to current treatments.

Who is the study for?
This trial is for individuals with a confirmed or likely diagnosis of invasive pulmonary aspergillosis (IPA) that hasn't improved despite standard antifungal treatment. Participants must not have allergies to PC945 or placebo components, should not have used PC945 before, and can't be in another clinical study.Check my eligibility
What is being tested?
The trial tests the effectiveness of an inhaled drug called PC945 combined with other systemic antifungal treatments against IPA. Some participants will receive PC945 while others will get a placebo, alongside their usual antifungal therapy.See study design
What are the potential side effects?
Potential side effects may include reactions related to allergy or hypersensitivity to the ingredients in PC945 or the placebo. Since it's combined with other antifungals, there could also be side effects from those medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks (day 84)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks (day 84) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants with Complete or Partial Overall Response
Secondary outcome measures
Time to Complete or Partial Overall Clinical Response

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PC945Experimental Treatment1 Intervention
PC945 dose, administered via nebulizer, twice daily
Group II: PlaceboPlacebo Group1 Intervention
PC945-placebo administered via nebulizer, twice daily

Find a Location

Who is running the clinical trial?

Pulmocide LtdLead Sponsor
9 Previous Clinical Trials
402 Total Patients Enrolled

Media Library

PC945 (Azole Antifungal) Clinical Trial Eligibility Overview. Trial Name: NCT05238116 — Phase 3
Invasive Pulmonary Aspergillosis Research Study Groups: PC945, Placebo
Invasive Pulmonary Aspergillosis Clinical Trial 2023: PC945 Highlights & Side Effects. Trial Name: NCT05238116 — Phase 3
PC945 (Azole Antifungal) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05238116 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does PC945 have any dangerous side effects that people should know about?

"There is both efficacy and safety data available for PC945, as it has gone through multiple rounds of testing in Phase 3 trials. Therefore, our team at Power rates the safety of this medication as a 3."

Answered by AI

Are there any sites outside of Canada conducting this research?

"This trial is being conducted at 5 sites which are located in cities such as Boston, New york and Houston. If you choose to participate, please select the site that is most conveniently located for you to reduce travel burden."

Answered by AI

How many people are participating in this clinical trial?

"Yes, this study is still recruiting patients. The listing on clinicaltrials.gov says that the trial was first posted on 6/14/2022 and last updated on 9/26/2022. There are 5 sites enrolling a total of 123 participants."

Answered by AI

Are new participants still being sought for this research project?

"The study is currently looking for patients, with the first posting on 6/14/2022 and most recent update on 9/26/2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)
2022. "Safety and Efficacy of PC945 (Opelconazole) in Combination With Other Antifungal Therapy for the Treatment of Refractory Invasive Pulmonary Aspergillosis (OPERA-T Study)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05238116.
~41 spots leftby Mar 2025
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