Voriconazole For Chronic Bronchopulmonary Aspergillosis

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00159822
First received: September 8, 2005
Last updated: January 13, 2010
Last verified: January 2010
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hyalohyphomycosis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
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 August 20, 2014