Voriconazole For Chronic Bronchopulmonary Aspergillosis

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

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

• Number of Subjects With Successful Global Outcome at 6 Months: Chronic Bronchopulmonary Aspergillosis
  • Time Frame: at 6 months of treatment
    Safety Issue?: No

Secondary Measures

• Number of Subjects With Successful Global Outcome at Month 3 and End of Treatment: Chronic Bronchopulmonary Aspergillosis
  • Time Frame: Month 3 and End of Treatment (Month 9 or Month 12)
    Safety Issue?: No
• Number of Subjects With Successful Global Outcome at 6 Months: Chronic Necrotizing Pulmonary Aspergillosis (CNPA) and Tracheo-bronchial Aspergillosis
  • Time Frame: at 6 months of treatment
    Safety Issue?: No
• Number of Subjects With Successful Global Outcome at 6 Months: Complex Aspergilloma
  • Time Frame: at 6 months of treatment
    Safety Issue?: No
• Change From Baseline in Respiratory Clinical Signs and Symptoms on Visual Analog Scales (VAS)
  • Time Frame: Baseline, Month 3, and Month 6, Month 9, or Month 12 [EOT], and End of study ([EOS] EOT + 6 months)
    Safety Issue?: No
• Number of Subjects With Relapse
  • Time Frame: During the 6 months following EOT (EOT + 3 months, EOT + 6 months)
    Safety Issue?: No
• Time to Relapse After EOT
  • Time Frame: During the 6 months following EOT (EOT + 3 months, EOT + 6 months)
    Safety Issue?: No
• Global Survival: Number of Subjects With an Outcome of Death
  • Time Frame: Baseline through EOS (EOT + 6 months)
    Safety Issue?: Yes
• Change From Baseline in Quality of Life (QOL): St. George's Hospital Respiratory Questionnaire
  • Time Frame: Baseline, Month 3, and Month 6, Month 9, or Month 12 [EOT], and EOS (EOT + 6 months)
    Safety Issue?: No
• Number of Subjects With Complete or Partial Radiological Response
  • Time Frame: Month 3, and Month 6, Month 9, or Month 12 [EOT]
    Safety Issue?: No
• Number of Subjects With Mycological Response of Eradication
  • Time Frame: Month 3, and Month 6, Month 9, or Month 12 [EOT]
    Safety Issue?: No
• Number of Subjects With Complete or Partial Serological Response
  • Time Frame: Month 3, and Month 6, Month 9, or Month 12 [EOT]
    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 Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on February 12, 2012

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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