Six Months Versus 12 Months of Oral Itraconazole Therapy for Management of Treatment naïve Subjects With CPA
Condition: Chronic Pulmonary Aspergillosis
MeSH terms: Aspergillosis; Pulmonary Aspergillosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The treatment options majorly consist of medical management with at least 6-month long
      treatment with antifungal drugs - most significantly the azole groups. Itraconazole is the
      preferred azole for the treatment of CPA. The duration of treatment with oral itraconazole
      remains uncertain. In a previous study the use of oral itraconazole for 6-months a favorable
      overall response was seen in 76% of the subjects. Moreover, about 30%-50% of the subjects
      have disease relapse that requires prolonged therapy. It is likely that a longer duration of
      itraconazole would have a higher response rate and thus, lower risk of relapse after
      discontinuation of therapy. In this randomized controlled trial, we compare the clinical
      outcomes of six months versus twelve months of itraconazole therapy in treatment naïve
      subjects with chronic pulmonary aspergillosis
    

Detailed description: 
      Aspergillus is a saprophytic fungus which is present normally in our surroundings and causes
      a large number of pulmonary diseases spreading through inhalational route. The spectrum of
      disease caused by aspergillus spp. is wide with the manifestations of the disease being
      governed primarily by the status of the underlying host immunity, which then determines the
      nature of the host-aspergillus interaction. Patients with an intact immunity have a more
      stable and indolent form of disease like aspergilloma whereas with a worsening immune status,
      the risk of invasive disease increases. Chronic pulmonary aspergillosis (CPA) and allergic
      bronchopulmonary aspergillosis (ABPA) are two of the commonest pulmonary manifestations seen
      in non-immunocompromised patients whereas invasive pulmonary aspergillosis being more common
      in the immunocompromised patients.

      Estimates suggest that CPA affects around 3 million people across the globe, which may still
      be an under estimated number as the disease co exists with other pulmonary co-morbidities
      which make accurate diagnosis a pitfall. In India the annual incidence of CPA was estimated
      in 2011 and varied between 27,000-0.17 million cases, with different estimates. Based on the
      mortality rate for CPA which was estimated to be 15% annually, the 5-year prevalence of CPA
      was placed at 290,147 cases with 5-year prevalence rate being 24 per 100,000 in the same
      year. The disease confers significant morbidity and mortality, making it a significant burden
      for the society as well as the healthcare. Apart from the respiratory symptoms, CPA causes
      significant constitutional symptoms as well which adds to the misery of the patient. The
      diagnosis of CPA is based on presence of chronic symptoms, consistent radiology and
      demonstration of Aspergillus by direct (culture) or indirect (serological) methods. Even
      though CPA is more of a disease spectrum but overall it is characterized by slowly
      progressive lung cavitation which may or may not show presence of mycetoma /fungal ball in
      patients with pre-existing structural lung diseases, even though other patterns have also
      been identified.

      The treatment options majorly consist of medical management with at least 6-month long
      treatment with antifungal drugs - most significantly the azole groups. Itraconazole is the
      preferred azole for the treatment of CPA. The duration of treatment with oral itraconazole
      remains uncertain. In a previous study the use of oral itraconazole for 6-months a favorable
      overall response was seen in 76% of the subjects. Moreover, about 30%-50% of the subjects
      have disease relapse that requires prolonged therapy. It is likely that a longer duration of
      itraconazole would have a higher response rate and thus, lower risk of relapse after
      discontinuation of therapy. In this randomized controlled trial, we compare the clinical
      outcomes of six months versus twelve months of itraconazole therapy in treatment naïve
      subjects with chronic pulmonary aspergillosis.
    

Intervention name(s): Itraconazole 400 mg
Intervention type(s): Drug
Intervention description(s): Duration of itraconazole
Other intervention name(s): sporanox
Intervention MeSH terms: Itraconazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CPA; Aspergillosis; CCPA; CFPA