Phase 3
N=48
Voriconazole For Chronic Bronchopulmonary Aspergillosis
Aspergillosis
Bottom Line
View on ClinicalTrials.gov: NCT00159822 ↗Enrolled (actual)
48
Serious AEs
43.8%
Results posted
Jan 2010
Primary outcome: Primary: Number of Subjects With Successful Global Outcome at 6 Months: Chronic Bronchopulmonary Aspergillosis — 13; 28 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Voriconazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Successful Global Outcome at 6 Months: Chronic Bronchopulmonary Aspergillosis |
13; 28 | — |
| SECONDARY Number of Subjects With Successful Global Outcome at Month 3 and End of Treatment: Chronic Bronchopulmonary Aspergillosis |
12; 24; 5; 18; 23 | — |
| SECONDARY Number of Subjects With Successful Global Outcome at 6 Months: Chronic Necrotizing Pulmonary Aspergillosis (CNPA) and Tracheo-bronchial Aspergillosis |
10; 9 | — |
| SECONDARY Number of Subjects With Successful Global Outcome at 6 Months: Complex Aspergilloma |
3; 19 | — |
| SECONDARY Change From Baseline in Respiratory Clinical Signs and Symptoms on Visual Analog Scales (VAS) |
-15.80; -19.63; -17.45; -30.13; -13.65; -2.67 | — |
| SECONDARY Number of Subjects With Relapse |
— | — |
| SECONDARY Time to Relapse After EOT |
— | — |
| SECONDARY Global Survival: Number of Subjects With an Outcome of Death |
5 | — |
| SECONDARY Change From Baseline in Quality of Life (QOL): St. George's Hospital Respiratory Questionnaire |
-5.50; -3.32; 0.96; -2.72; -6.84; -4.15 | — |
| SECONDARY Number of Subjects With Complete or Partial Radiological Response |
4; 9; 6; 14 | — |
| SECONDARY Number of Subjects With Mycological Response of Eradication |
29; 3; 3; 26; 6; 14 | — |
| SECONDARY Number of Subjects With Complete or Partial Serological Response |
10; 14; 9; 8 | — |
Summary
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00159822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.