Status:

UNKNOWN

Efficacy of Intrabronchial Voriconazole Instillation for Inoperable Pulmonary Aspergilloma

Lead Sponsor:

All India Institute of Medical Sciences

Conditions:

Aspergilloma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

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 fe...

Detailed Description

Primary Objective : To compare the percentage of patients achieving reduction in hemoptysis in intrabronchial voriconazole with standard medical therapy group vs standard medical therapy alone for ino...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 1 2016

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 30 2019

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT03799809

Start Date

December 1 2016

End Date

January 30 2019

Last Update

January 10 2019

Active Locations (1)

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Page 1 of 1 (1 locations)

1

All India Institute of Medical Sciences

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