Voriconazole For Chronic Bronchopulmonary Aspergillosis

Aspergillosis Clinical Trial

Official title:

Voriconazole For Primary Therapy Of Proven, Chronic Bronchopulmonary Aspergillosis, In Minimally Immunocompromised Or, Non-Immunocompromised Hosts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00159822
• Other study ID #: A1501061
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 8, 2005
• Last updated: January 13, 2010
• Start date: July 2005
• Est. completion date: December 2008

Study information

• Verified date: January 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aspergillosis
• Pulmonary Aspergillosis

Intervention

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

Locations

Country	Name	City	State
France	Pfizer Investigational Site	Angers Cedex
France	Pfizer Investigational Site	Bobigny
France	Pfizer Investigational Site	Brest Cedex
France	Pfizer Investigational Site	Bris Sous Forges
France	Pfizer Investigational Site	Caen Cedex
France	Pfizer Investigational Site	Dinan Cedex
France	Pfizer Investigational Site	Grenoble Cedex 09
France	Pfizer Investigational Site	Lille Cedex
France	Pfizer Investigational Site	Lyon Cedex
France	Pfizer Investigational Site	Montpellier Cedex 5
France	Pfizer Investigational Site	Nantes	Cedex
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Paris Cedex 18
France	Pfizer Investigational Site	Paris Cedex 20
France	Pfizer Investigational Site	Poitiers Cedex
France	Pfizer Investigational Site	Reims Cedex
France	Pfizer Investigational Site	Rouen Cedex
France	Pfizer Investigational Site	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

France, 

Outcome

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

External Links

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