Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03920527 |
Other study ID # |
NK/4947/Res/986 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 3
|
First received |
|
Last updated |
|
Start date |
July 1, 2019 |
Est. completion date |
August 15, 2021 |
Study information
Verified date |
October 2021 |
Source |
Postgraduate Institute of Medical Education and Research |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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
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.