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Voriconazole For Chronic Bronchopulmonary Aspergillosis

Pfizer logo

Pfizer

Status and phase

Completed
Phase 3
Phase 2

Conditions

Aspergillosis

Treatments

Drug: Voriconazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00159822
A1501061

Details and patient eligibility

About

To evaluate the efficacy of voriconazole (VFend(R)) as first line treatment for proven chronic bronchopulmonary aspergillosis, in minimally immunocompromised or non-immunocompromised patients after 6 months of treatment i.e. chronic necrotizing pulmonary

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with a chronic bronchopulmonary aspergillosis assessed by a compatible chest imagery (CT scan) and/or an endoscopic lesion sourced by photo, would it be:
  • Complex aspergilloma non primarily operable,
  • Chronic necrotizing pulmonary aspergillosis,
  • Tracheo-bronchial aspergillosis, obstructive or necrotizing/pseudo-membranous.

Exclusion criteria

  • Patient with risk factor(s) of cardiac arrhythmia, symptomatic arrhythmia, treated by medication known to prolong QT interval, or prolongation of QTc interval > 450 msec in men and > 470 msec in women.
  • Simple aspergilloma with primary indication of surgical treatment.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

48 participants in 1 patient group

1
Experimental group
Treatment:
Drug: Voriconazole

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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