Clinical trial NCT00159822: Voriconazole For Chronic Bronchopulmonary Aspergillosis
Official title: Voriconazole For Primary Therapy Of Proven, Chronic Bronchopulmonary Aspergillosis, In Minimally Immunocompromised Or, Non-Immunocompromised Hosts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Aspergillosis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Number of Subjects With Successful Global Outcome at 6 Months: Chronic Bronchopulmonary Aspergillosis
timeFrame: at 6 months of treatment
Secondary outcomes:
measure: Number of Subjects With Successful Global Outcome at Month 3 and End of Treatment: Chronic Bronchopulmonary Aspergillosis
timeFrame: Month 3 and End of Treatment (Month 9 or Month 12)
measure: Number of Subjects With Successful Global Outcome at 6 Months: Chronic Necrotizing Pulmonary Aspergillosis (CNPA) and Tracheo-bronchial Aspergillosis
timeFrame: at 6 months of treatment
measure: Number of Subjects With Successful Global Outcome at 6 Months: Complex Aspergilloma
timeFrame: at 6 months of treatment
measure: Change From Baseline in Respiratory Clinical Signs and Symptoms on Visual Analog Scales (VAS)
timeFrame: Baseline, Month 3, and Month 6, Month 9, or Month 12 [EOT], and End of study ([EOS] EOT + 6 months)
measure: Number of Subjects With Relapse
timeFrame: During the 6 months following EOT (EOT + 3 months, EOT + 6 months)
measure: Time to Relapse After EOT
timeFrame: During the 6 months following EOT (EOT + 3 months, EOT + 6 months)
measure: Global Survival: Number of Subjects With an Outcome of Death
timeFrame: Baseline through EOS (EOT + 6 months)
measure: Change From Baseline in Quality of Life (QOL): St. George's Hospital Respiratory Questionnaire
timeFrame: Baseline, Month 3, and Month 6, Month 9, or Month 12 [EOT], and EOS (EOT + 6 months)
measure: Number of Subjects With Complete or Partial Radiological Response
timeFrame: Month 3, and Month 6, Month 9, or Month 12 [EOT]
measure: Number of Subjects With Mycological Response of Eradication
timeFrame: Month 3, and Month 6, Month 9, or Month 12 [EOT]
measure: Number of Subjects With Complete or Partial Serological Response
timeFrame: Month 3, and Month 6, Month 9, or Month 12 [EOT]
Other outcomes:
Locations:
city: Nantes
country: France
facility: Pfizer Investigational Site
state: Cedex
city: Angers Cedex
country: France
facility: Pfizer Investigational Site
city: Bobigny
country: France
facility: Pfizer Investigational Site
city: Brest Cedex
country: France
facility: Pfizer Investigational Site
city: Bris Sous Forges
country: France
facility: Pfizer Investigational Site
city: Caen Cedex
country: France
facility: Pfizer Investigational Site
city: Dinan Cedex
country: France
facility: Pfizer Investigational Site
city: Grenoble Cedex 09
country: France
facility: Pfizer Investigational Site
city: Lille Cedex
country: France
facility: Pfizer Investigational Site
city: Lyon Cedex
country: France
facility: Pfizer Investigational Site
city: Montpellier Cedex 5
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 18
country: France
facility: Pfizer Investigational Site
city: Paris Cedex 20
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Poitiers Cedex
country: France
facility: Pfizer Investigational Site
city: Reims Cedex
country: France
facility: Pfizer Investigational Site
city: Rouen Cedex
country: France
facility: Pfizer Investigational Site
city: Suresnes
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: