NCT03799809

Efficacy of Intrabronchial Voriconazole Instillation for Inoperable Pulmonary Aspergilloma

Status unknown Phase 2, PHASE3 Last updated 10 January 2019

What this trial tests

Phase 2, PHASE3 trial testing Intrabronchial Voriconazole instillation in Aspergilloma in 60 participants. Status unknown.

Timeline

1 December 2016

Primary endpoint
30 December 2018

30 January 2019

Quick facts

Lead sponsor	All India Institute of Medical Sciences
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	1 December 2016
Primary completion	30 December 2018
Estimated completion	30 January 2019
Sites	1 location across India

Drugs / interventions tested

• Intrabronchial Voriconazole instillation — full drug profile →

Conditions studied

• Aspergilloma — all drugs for Aspergilloma →

Sponsor

All India Institute of Medical Sciences

Who can join

18 and older, any sex, with Aspergilloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.