Itraconazole for Bronchiectasis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of itraconazole, an antifungal medication, for people with bronchiectasis who have mold in their airways. Researchers aim to determine treatment adherence, its impact on breathing, and any changes in lung germ types. This trial may suit those diagnosed with bronchiectasis, who have recently detected mold in their lung cultures, and are not currently on other antimicrobial treatments. As a Phase 4 trial, itraconazole is already FDA-approved and proven effective, providing an opportunity to assess its benefits for more patients.
Will I have to stop taking my current medications?
You may need to stop taking certain medications to join this trial. Specifically, you cannot use medications like rifampin, simvastatin, or certain blood thinners. Check with the trial team to see if your current medications are on the exclusion list.
What is the safety track record for itraconazole?
Research has shown that long-term use of itraconazole is generally safe. In one study, 24 out of 60 patients experienced side effects, and some needed to adjust their dosage. This indicates that while itraconazole can cause issues for some, many tolerate it well. Another study found that itraconazole improved lung health, making it a promising option for those with breathing issues. Since itraconazole is already used for other conditions, much is known about its safety. However, discussing any concerns with a doctor is important.12345
Why are researchers enthusiastic about this study treatment?
Unlike other treatments for bronchiectasis, which typically focus on antibiotics or airway clearance therapies, itraconazole is an antifungal medication that targets airway mold. This is significant because fungal infections can exacerbate bronchiectasis symptoms, and addressing them could lead to better management of the condition. Researchers are excited about itraconazole because it offers a novel approach by potentially reducing the fungal burden in the lungs, thereby improving respiratory outcomes for patients with this challenging condition.
What evidence suggests that itraconazole might be an effective treatment for bronchiectasis?
Research has shown that itraconazole can help treat breathing problems caused by fungal infections. For instance, one study found that people with severe asthma who took itraconazole for 32 weeks experienced an improved quality of life. Another study discovered that long-term use of itraconazole reduced bronchial wall thickness and improved symptoms in asthma patients. Although these studies focus on conditions like asthma, they suggest that itraconazole might help manage breathing issues related to fungal infections. This trial investigates its potential benefits for participants with bronchiectasis and airway mold.1356
Who Is on the Research Team?
Amjad Kanj, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for individuals with bronchiectasis who also have mold in their airways. Participants should be willing to adhere to the treatment plan and continue throughout the study period. Specific eligibility details are not provided, but typically include age range, disease severity, and absence of certain medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive itraconazole therapy for bronchiectasis with airway mold
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Itraconazole
Trial Overview
The trial is testing if itraconazole (a fungal medication) at a dose of 200 mg can be a feasible treatment for patients with bronchiectasis affected by airway mold. It looks at how easy it is to recruit participants, if they stick with the treatment, its tolerability, and whether they stay in the study.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Subjects with bronchiectasis and airway mold
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Citations
Itraconazole Therapy In Bronchiectasis With Airway Mold
Study Overview. The primary objective of this study is to evaluate the feasibility of itraconazole therapy in patients with bronchiectasis and ...
Effectiveness of Low-Dose Itraconazole in Fungal- ...
Denning et al demonstrated that orally administering itraconazole for 32 weeks improved the quality of life of severe asthmatics with fungal sensitization.
A Double-blind Placebo-controlled Randomized Clinical Trial
Long-term treatment with itraconazole resulted in a significant reduction in bronchial wall thickness and improvements in clinical findings and pulmonary ...
Itraconazole Therapy In Bronchiectasis With Airway Mold
The primary objective of this study is to evaluate the feasibility of itraconazole therapy in patients with bronchiectasis and airway mold.
5.
clinicaltrials.gov
clinicaltrials.gov/study/NCT07283497?term=%22Principal+Investigator%22+OR+%22Investigator%22+AND+%22Gerald+O%27Brien%22Itraconazole Therapy In Bronchiectasis With Airway Mold
Feasibility will be assessed through recruitment success, treatment adherence, tolerability, and participant retention.
Itraconazole in chronic pulmonary aspergillosis: In whom, ...
The study shows that long-term administration of itraconazole is safe. Of the 60 patients, adverse events were noted in 24 patients and the drug dose had to be ...
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