Voriconazole For Chronic Bronchopulmonary Aspergillosis
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00159822
First received: September 8, 2005
Last updated: January 13, 2010
Last verified: January 2010
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Aspergillosis |
Drug: Voriconazole |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Voriconazole For Primary Therapy Of Proven, Chronic Bronchopulmonary Aspergillosis, In Minimally Immunocompromised Or, Non-Immunocompromised Hosts |
Resource links provided by NLM:
MedlinePlus related topics:
Aspergillosis
Drug Information available for:
Voriconazole
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Number of Subjects With Successful Global Outcome at 6 Months: Chronic Bronchopulmonary Aspergillosis [ Time Frame: at 6 months of treatment ] [ Designated as safety issue: No ]
Secondary Outcome 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) ] [ Designated as 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 ] [ Designated as safety issue: No ]
- Number of Subjects With Successful Global Outcome at 6 Months: Complex Aspergilloma [ Time Frame: at 6 months of treatment ] [ Designated as 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) ] [ Designated as safety issue: No ]
- Number of Subjects With Relapse [ Time Frame: During the 6 months following EOT (EOT + 3 months, EOT + 6 months) ] [ Designated as safety issue: No ]
- Time to Relapse After EOT [ Time Frame: During the 6 months following EOT (EOT + 3 months, EOT + 6 months) ] [ Designated as safety issue: No ]
- Global Survival: Number of Subjects With an Outcome of Death [ Time Frame: Baseline through EOS (EOT + 6 months) ] [ Designated as 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) ] [ Designated as 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] ] [ Designated as safety issue: No ]
- Number of Subjects With Mycological Response of Eradication [ Time Frame: Month 3, and Month 6, Month 9, or Month 12 [EOT] ] [ Designated as 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] ] [ Designated as safety issue: No ]
| Enrollment: | 48 |
| Study Start Date: | July 2005 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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 |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159822
Locations
| France | |
| Pfizer Investigational Site | |
| Nantes, Cedex, France, 44093 | |
| Pfizer Investigational Site | |
| Angers Cedex, France, 49033 | |
| Pfizer Investigational Site | |
| Bobigny, France, 93000 | |
| Pfizer Investigational Site | |
| Brest Cedex, France, 29609 | |
| Pfizer Investigational Site | |
| Bris Sous Forges, France, 94640 | |
| Pfizer Investigational Site | |
| Caen Cedex, France, 14033 | |
| Pfizer Investigational Site | |
| Dinan Cedex, France, 22101 | |
| Pfizer Investigational Site | |
| Grenoble Cedex 09, France, 38043 | |
| Pfizer Investigational Site | |
| Lille Cedex, France, 59037 | |
| Pfizer Investigational Site | |
| Lyon Cedex, France, 69394 | |
| Pfizer Investigational Site | |
| Montpellier Cedex 5, France, 34295 | |
| Pfizer Investigational Site | |
| Paris, France, 75010 | |
| Pfizer Investigational Site | |
| Paris Cedex 18, France, 75877 | |
| Pfizer Investigational Site | |
| Paris Cedex 20, France, 75970 | |
| Pfizer Investigational Site | |
| Poitiers Cedex, France, 86021 | |
| Pfizer Investigational Site | |
| Reims Cedex, France, 51092 | |
| Pfizer Investigational Site | |
| Rouen Cedex, France, 76031 | |
| Pfizer Investigational Site | |
| Suresnes, France, 92150 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00159822 History of Changes |
| Other Study ID Numbers: | A1501061 |
| Study First Received: | September 8, 2005 |
| Results First Received: | December 2, 2009 |
| Last Updated: | January 13, 2010 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Aspergillosis Pulmonary Aspergillosis Mycoses Lung Diseases, Fungal Lung Diseases Respiratory Tract Diseases Voriconazole |
Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013