Voriconazole for IPA in Chinese Patients With COPD (VIA-COPD)

Red Cross Hospital, Hangzhou, China

Status and phase

Unknown

Phase 4

Conditions

Invasive Pulmonary Aspergillosis

COPD

Treatments

Drug: Voriconazole

Study type

Interventional

Funder types

Other

Identifiers

NCT02234739

Hangzhou Red Cross Hospital

Details and patient eligibility

About

voriconazole is recommended as first-line therapy for invasive pulmonary aspergillosis, however the efficacy and safety of voriconazole for treating invasive pulmonary aspergillosis secondary to COPD is not clear. This study aims to investigate the effectiveness and tolerability of intravenous voriconazole for treatment of invasive pulmonary aspergillosis in Chinese patients with COPD, by monitoring changes in clinical symptoms, eradication of aspergillus, improvement of chest imaging as well as record of possible adverse reactions following 2-week intravenous instillation of voriconazole.

Full description

This is a multiple-center open-label clinical trial to study the efficacy and safety of voriconazole for treating invasive pulmonary aspergillosis secondary to COPD in Chinese patients.The primary endpoint is treatment success rate as defined by improvement of symptoms related to invasive pulmonary asperillosis, secondary endpoints include the mortality, the eradication of sputum asperillus and profile of adverse reactions following intravenous instillation of voriconazole.

Enrollment

40 estimated patients

Sex

All

Ages

30 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Cases of invasive pulmonary aspergillosis secondary to COPD

Exclusion criteria

Use of voriconazole or itraconazole or amphotericin B or caspofungin or micafungin within 4 weeks prior to enrollment
Known allergy to voriconazole
Severe impairment of live or kidney function
Septic shock
Unwilling to sign informed consent