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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 Aspergillosis

Number 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

Page last updated: August 23, 2015

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