Aspergilloma Clinical Trial
Official title:
Efficacy of Intrabronchial Voriconazole Instillation for Inoperable Pulmonary Aspergilloma- a Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | January 30, 2019 |
Est. primary completion date | December 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
India | All India Institute of Medical Sciences | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
All India Institute of Medical Sciences, New Delhi |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | To compare the percentage of patients who have complete cessation of hemoptysis after 3 months. | percentage of patients who have complete cessation of hemoptysis after 3 months. | 3 months follow up | |
Secondary | To compare the percentage of patients having recurrence of hemoptysis during 3 months follow up. | percentage of patients having recurrence of hemoptysis during 3 months follow up. | 3 months follow up | |
Secondary | To compare the severity of hemoptysis during recurrence in both groups. | severity of hemoptysis during recurrence in both groups shall be compared with visual analogue scale. | 3 months follow up | |
Secondary | To compare the change in size of aspergilloma after 3 months following last intrabronchial voriconazole instillation. | change in size of aspergilloma after 3 months following last intrabronchial voriconazole instillation. | 3 months follow up | |
Secondary | To compare the percentage of patients who need BAE during anytime till 3 months. | percentage of patients who need BAE during anytime till 3 months. | 3 months follow up | |
Secondary | To compare the percentage of patients with symptomatic improvement in Dyspnea On Exertion, Cough and hemoptysis. | percentage of patients with symptomatic improvement in Dyspnea On Exertion, Cough and hemoptysis. | 3 months follow up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06447402 -
A Trial to Compare Nebulized Amphotericin B and Nebulized Normal Saline as Maintenance in Patients With Chronic Pulmonary Aspergillosis
|
Phase 3 |