Efficacy of Intrabronchial Voriconazole Instillation for Inoperable Pulmonary Aspergilloma

NCT03799809 | Unknown Phase 2

• 1 other identifier: AIIMS SACHIN
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary aspergillomas are a common cause of recurrent hemoptysis which may be moderate to severe in 2 to 50 % of cases and may be life threatening. Surgical resection, though curative, may not be feasible in significant number of patients and also associated significant post op complications. Bronchial artery embolisation (BAE) is effective for acute control of hemoptysis, however recurrences may occur in upto a quarter of subjects over a 1 year period. Aspergilloma is caused by a fungus hence systemic antifungals seem appropriate choice. However the fungus only partially touch the walls of the cavities containing them and rarely come into contact with the bloodstream. This is the major reason why the systemic administration of antifungal agents is ineffective in eradicating the condition. If surgical resection is not a treatment option to control recurrent hemoptysis, instillation of antifungal agents in an aspergilloma cavity could be considered(QoE II).The instillation of antifungal directly into the cavity (intra-cavitatory) containing aspergilloma brings the drug in contact with the fungus. Thus may lead to antifungal action and shrinkage or complete disappearance of aspergilloma. This can be achieved either by percutaneous route or bronchoscopically. Percutaneous approaches have been investigated however they can sometimes cause fungal spread in thoracic space resulting in fungal empyema which should be carefully avoided. Endobronchial instillation of antifungals have been investigated and found to be safe and effective in controlling hemoptysis, however published data comprise of case reports or small case series. Recently we have published our experience of intrabronchial voriconazole in aspergilloma among 82 patients and found to be safe and effective in hemoptysis control, with transient post procedure cough as an adverse effect with no major serious adverse events. Multiple small studies and case reports have published the safety and efficacy of voriconazole. However, a quality data in the form of randomized controlled trial (RCT) is not there. Therefore, we planned this RCT to assess the efficacy of intrabronchial voriconazole in inoperable aspergilloma.

Conditions

Aspergilloma

Outcome Measures

Primary Outcomes (1)

• To compare the percentage of patients achieving reduction in hemoptysis in intrabronchial voriconazole with standard medical therapy group vs standard medical therapy alone for inoperable pulmonary aspergilloma at 3 months.

  Percentage of patients achieving reduction in hemoptysis in intrabronchial voriconazole with standard medical therapy group vs standard medical therapy alone for inoperable pulmonary aspergilloma at 3 months.

  3 months follow up

Secondary Outcomes (6)

• To compare the percentage of patients who have complete cessation of hemoptysis after 3 months.

  3 months follow up

• To compare the percentage of patients having recurrence of hemoptysis during 3 months follow up.

  3 months follow up

• To compare the severity of hemoptysis during recurrence in both groups.

  3 months follow up

• To compare the change in size of aspergilloma after 3 months following last intrabronchial voriconazole instillation.

  3 months follow up

• To compare the percentage of patients who need BAE during anytime till 3 months.

  3 months follow up

Study Arms (2)

Voriconazole

ACTIVE COMPARATOR

Will receive 400 mg of Intrabronchial Voriconazole every week for 4 weeks along with standard medical therapy.

Drug: Intrabronchial Voriconazole instillation

Control

NO INTERVENTION

Will receive standard medical therapy alone (hemostatics, anti-tussive and others as deemed appropriate by treating physician)

Interventions

Intrabronchial Voriconazole instillation DRUG

Efficacy of intrabronchial voriconazole instillation for inoperable pulmonary aspergilloma

Voriconazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with mild to moderate hemoptysis AND inoperable aspergilloma/ those unwilling for surgery.
• Who have no contra-indication of flexible fibre-optic bronchoscopy
• Age \> 18 yrs AND
• Given the written informed consent to participate in the study.

You may not qualify if:

• Patient who are not fit for FOB (e.g. hemodynamic instability)
• Patient who have life threatening hemoptysis requiring immediate bronchial artery embolization
• Patients who have underwent BAE in last 3 months
• Pregnant woman

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Study Sites (1)

All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, 110029, India

RECRUITING

Central Study Contacts

SACHIN D, MD

CONTACT

8129840208; sachinmedico@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior resident

Study Record Dates

• First Submitted: October 20, 2018
• First Posted: January 10, 2019
• Study Start: December 1, 2016
• Primary Completion: December 30, 2018
• Study Completion: January 30, 2019
• Last Updated: January 10, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)