Voriconazole For Chronic Bronchopulmonary Aspergillosis
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Aspergillosis
Intervention: Voriconazole (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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
Clinical Details
Official title: Voriconazole For Primary Therapy Of Proven, Chronic Bronchopulmonary Aspergillosis, In Minimally Immunocompromised Or, Non-Immunocompromised Hosts
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of Subjects With Successful Global Outcome at 6 Months: Chronic Bronchopulmonary Aspergillosis
Secondary outcome: Number of Subjects With Successful Global Outcome at Month 3 and End of Treatment: Chronic Bronchopulmonary AspergillosisNumber of Subjects With Successful Global Outcome at 6 Months: Chronic Necrotizing Pulmonary Aspergillosis (CNPA) and Tracheo-bronchial Aspergillosis Number of Subjects With Successful Global Outcome at 6 Months: Complex Aspergilloma Change From Baseline in Respiratory Clinical Signs and Symptoms on Visual Analog Scales (VAS) Number of Subjects With Relapse Time to Relapse After EOT Global Survival: Number of Subjects With an Outcome of Death Change From Baseline in Quality of Life (QOL): St. George's Hospital Respiratory Questionnaire Number of Subjects With Complete or Partial Radiological Response Number of Subjects With Mycological Response of Eradication Number of Subjects With Complete or Partial Serological Response
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Pfizer Investigational Site, Angers Cedex 49033, France
Pfizer Investigational Site, Bobigny 93000, France
Pfizer Investigational Site, Brest Cedex 29609, France
Pfizer Investigational Site, Bris Sous Forges 94640, France
Pfizer Investigational Site, Caen Cedex 14033, France
Pfizer Investigational Site, Dinan Cedex 22101, France
Pfizer Investigational Site, Grenoble Cedex 09 38043, France
Pfizer Investigational Site, Lille Cedex 59037, France
Pfizer Investigational Site, Lyon Cedex 69394, France
Pfizer Investigational Site, Montpellier Cedex 5 34295, France
Pfizer Investigational Site, Paris Cedex 18 75877, France
Pfizer Investigational Site, Paris Cedex 20 75970, France
Pfizer Investigational Site, Paris 75010, France
Pfizer Investigational Site, Poitiers Cedex 86021, France
Pfizer Investigational Site, Reims Cedex 51092, France
Pfizer Investigational Site, Rouen Cedex 76031, France
Pfizer Investigational Site, Suresnes 92150, France
Pfizer Investigational Site, Nantes, Cedex 44093, France
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: July 2005
Last updated: January 13, 2010
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