Official Title: “Voriconazole For Primary Therapy Of Proven, Chronic Bronchopulmonary Aspergillosis, In Minimally Immunocompromised Or, Non-Immunocompromised Hosts”

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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: Voriconazole
  • Voriconazole oral : loading dose on day 1 : 400mg/12 hours; maintenance dose 200 mg /12 hours for 6 to 12 months depending on clinical response. Alternatively, patients may start on Voriconazole, IV, for 7 days loading dose, 6mg/Kg/12 hours on day one and maintenance dose 4 mg/Kg/12 hours

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• 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.
  • Time Frame: after 6 months of treatment
    Safety Issue?: No
• i.e. chronic necrotizing pulmonary aspergillosis (CNPA), complex aspergilloma, necrotizing/pseudomembranous or obstructive tracheo-bronchial aspergillosis .
  • Time Frame: after 6 months of treatment
    Safety Issue?: No

Secondary Measures

• To evaluate the efficacy to prevent relapse of the aspergillosis during the 6 months following the end of treatment.
  • Time Frame: during the 6 months following the end of treatment
    Safety Issue?: No
• To evaluate the efficacy of voriconazole after 3 months of treatment and after 9 or 12 months in case of extension of the treatment period beyond 6 months.
  • Time Frame: 3 months of treatment and after 9 or 12 months in case of extension of the treatment period beyond 6
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00159822

Study ID Number: A1501061

ClinicalTrials.gov Identifier: NCT00159822

Health Authority: France: Afssaps - French Health Products Safety Agency

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