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Trial record 1 of 1 for:    NCT00159822
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Voriconazole For Chronic Bronchopulmonary Aspergillosis

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ClinicalTrials.gov Identifier: NCT00159822
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : January 7, 2010
Last Update Posted : January 20, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 12, 2005
Results First Submitted Date  ICMJE December 2, 2009
Results First Posted Date  ICMJE January 7, 2010
Last Update Posted Date January 20, 2010
Study Start Date  ICMJE July 2005
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2009)
Number of Subjects With Successful Global Outcome at 6 Months: Chronic Bronchopulmonary Aspergillosis [ Time Frame: at 6 months of treatment ]
Successful global outcome: composite assessment of radiological and mycological responses; defined as complete or partial radiological response and mycological eradication (absence of aspergillus); no success=criteria not met. Assessment was determined by the Data Review Committee (DRC). Complete response: resolution of radiographic and or bronchoscopic abnormalities attributable to aspergillosis present at baseline; partial response: reduction in diameter ≥ 50 percent on chest tomodensitometry (TDM) or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
To evaluate the efficacy of voriconazole (VFend(R)) as first line treatment for proven chronic bronchopulmonary aspergillosis, i.e. chronic necrotizing pulmonary aspergillosis (CNPA), complex aspergilloma, necrotizing/pseudomembranous or obstructive trac
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2010)
  • 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) ]
    Successful global outcome: composite assessment of radiological and mycological responses; defined as complete (resolution of radiographic and or bronchoscopic abnormalities attributable to aspergillosis present at baseline) or partial (reduction in diameter ≥ 50 percent on chest TDM or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion) radiological response and mycological eradication after 3 months of treatment and after 9 or 12 months (in case of extension of treatment period beyond 6 months); no success=criteria not met. Assessment determined by DRC.
  • 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 ]
    Successful global outcome: composite assessment of radiological and mycological responses; defined as complete or partial radiological response and mycological eradication (absence of aspergillus); no success=criteria not met. Assessment was determined by the Data Review Committee (DRC). Complete response: resolution of all radiographic and or bronchoscopic abnormalities attributable to the aspergillosis present at baseline; partial response: reduction in diameter ≥ 50% on chest tomodensitometry (TDM) or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.
  • Number of Subjects With Successful Global Outcome at 6 Months: Complex Aspergilloma [ Time Frame: at 6 months of treatment ]
    Successful global outcome: composite assessment of radiological and mycological responses; defined as complete or partial radiological response and mycological eradication (absence of aspergillus); no success=criteria not met. Assessment was determined by the Data Review Committee (DRC). Complete response: resolution of all radiographic and or bronchoscopic abnormalities attributable to the aspergillosis present at baseline; partial response: reduction in diameter ≥ 50% on chest tomodensitometry (TDM) or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.
  • 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) ]
    Subject assessment of improvement of respiratory clinical signs and symptoms as indicated by the subject placing a mark on a 10 cm VAS scored 0 (better state of health) to 100 (poor state of health) for cough, dyspnea, sputum, hemoptysis, chest tightness, and nocturnal awakening. Change from baseline: mean of (value of scores on scale at treatment visit minus baseline value).
  • Number of Subjects With Relapse [ Time Frame: During the 6 months following EOT (EOT + 3 months, EOT + 6 months) ]
    Relapse: any proven reappearance of pulmonary aspergillosis during the follow-up period, following a successful global outcome at EOT, and defined as a deterioration of clinical signs and symptoms, confirmed radiologically (chest [TDM] and or endoscopy) and mycologically (histology and or culture and or serology).
  • Time to Relapse After EOT [ Time Frame: During the 6 months following EOT (EOT + 3 months, EOT + 6 months) ]
    Time (months) to relapse: any proven reappearance of pulmonary aspergillosis during the follow-up period, following a successful global outcome at EOT, and defined as a deterioration of clinical signs and symptoms, confirmed radiologically (chest [TDM] and or endoscopy) and mycologically (histology and or culture and or serology).
  • Global Survival: Number of Subjects With an Outcome of Death [ Time Frame: Baseline through EOS (EOT + 6 months) ]
    Number of subjects with an outcome of death (adverse event with a fatal outcome) through end of study.
  • 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) ]
    Subject administered questionnaire to measure improvement in QOL; 50 questions exploring 3 different areas: symptoms, impact on activity profile (activity), and impact on daily life (impacts). Each item in an area is weighted based on empirical data; scores range from lowest possible weight 0 to highest possible weight 100. Scores for each section and total score calculated using score calculation algorithms with higher scores indicating poor health. Change from baseline: mean of (value of scores on scale at treatment visit minus baseline value).
  • Number of Subjects With Complete or Partial Radiological Response [ Time Frame: Month 3, and Month 6, Month 9, or Month 12 [EOT] ]
    Radiological response: based on chest TDM except for tracheo-bronchialaspergillosis which was assessed by bronchoscopy. Complete response: resolution of all radiographic and or bronchoscopic abnormalities attributable to aspergillosis present at baseline; partial response: reduction in diameter ≥ 50% on chest TDM or regressed lesion on endoscopy witnessed by 2 different operators without any new lesion.
  • Number of Subjects With Mycological Response of Eradication [ Time Frame: Month 3, and Month 6, Month 9, or Month 12 [EOT] ]
    Mycological response: eradication: absence of aspergillus species (spp) in bronchopulmonary samples: sputum, bronchial aspirate or bronchoalveolar lavage (BAL) (negative direct examination [exam] and negative culture), and negative histological exam when available; persistence (no eradication): presence of aspergillus spp in any relevant bronchopulmonary samples. Not done (presumed eradication): case reviewed by DRC for any mycological exams not performed to assess if case should constitute presumed eradication (no sputum due to clinical improvement).
  • Number of Subjects With Complete or Partial Serological Response [ Time Frame: Month 3, and Month 6, Month 9, or Month 12 [EOT] ]
    Serological response: normalization (complete response) defined as return to normal values (≤ 1 arc); partial response defined as significant decrease but not complete (decrease of 2 or more arcs compared to baseline). Complete or partial response summarized as Improvement; based on arc values at visit compared to arc values at baseline (inclusion).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
To evaluate the efficacy of voriconazole after 3 months of treatment and after 9 or 12 months in case of extension of the treatment period beyond 6 months, the efficacy to prevent relapse of the aspergillosis during the 6 months following the End of Trea
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Voriconazole For Chronic Bronchopulmonary Aspergillosis
Official Title  ICMJE Voriconazole For Primary Therapy Of Proven, Chronic Bronchopulmonary Aspergillosis, In Minimally Immunocompromised Or, Non-Immunocompromised Hosts
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aspergillosis
Intervention  ICMJE 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

Study Arms  ICMJE Experimental: 1
Intervention: Drug: Voriconazole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 31, 2007)
48
Original Enrollment  ICMJE
 (submitted: September 8, 2005)
45
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date December 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00159822
Other Study ID Numbers  ICMJE A1501061
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP