title: Itraconazole in chronic cavitary pulmonary aspergillosis: a randomised controlled trial and systematic review of literature.
abstract: Patients with aspergilloma can be safely managed with supportive therapy in absence of massive haemoptysis. We hypothesised that chronic cavitary pulmonary aspergillosis (CCPA) could also be managed on similar grounds. The aim of this prospective, randomised controlled trial was to evaluate the efficacy and safety of itraconazole in CCPA. Consecutive patients of CCPA with presence of chronic pulmonary/systemic symptoms; and pulmonary cavities; and presence of Aspergillus (immunological or microbiological) were randomised to receive either supportive treatment alone or itraconazole 400 mg daily for 6 months plus supportive therapy. Response was assessed clinically, radiologically and overall after 6 months therapy. A total of 31 patients (mean age, 37 years) were randomised to itraconazole (n = 17) or the control (n = 14) group. The number of patients showing overall response was significantly higher in the itraconazole group (76.5%) vs. the control (35.7%) group (P = 0.02). The numbers of patients demonstrating clinical or radiological response were also significantly higher in the itraconazole group (P = 0.016 and 0.01 respectively). Adverse events were noted in eight patients in the itraconazole group, however, none was serious or led to discontinuation of the study drug. Itraconazole was found to be superior to standard supportive treatment alone in stabilising cases of CCPA. (clinicaltrials.gov; NCT01259336).
authors.affiliation: Department of Pulmonary Medicine, Postgraduate Institute of Medical Education and Research, Chandigarh, India. riteshpgi@gmail.com
authors.forename: Ritesh
authors.initials: R
authors.lastname: Agarwal
authors.forename: Gella
authors.initials: G
authors.lastname: Vishwanath
authors.forename: Ashutosh N
authors.initials: AN
authors.lastname: Aggarwal
authors.forename: Mandeep
authors.initials: M
authors.lastname: Garg
authors.forename: Dheeraj
authors.initials: D
authors.lastname: Gupta
authors.forename: Arunaloke
authors.initials: A
authors.lastname: Chakrabarti
mesh_terms: D000328:Adult; D000935:Antifungal Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002908:Chronic Disease; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006801:Humans; D017964:Itraconazole / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D011446:Prospective Studies; D055732:Pulmonary Aspergillosis / Q000188:drug therapy* / Q000473:pathology; D013902:Radiography, Thoracic; D016896:Treatment Outcome
chemical_list: D000935:Antifungal Agents; D017964:Itraconazole
keywords: Aspergillus; CCPA; CNPA; aspergilloma; chronic pulmonary aspergillosis