Clinical trial NCT02440009: A Randomized Trial of Itraconazole in Acute Stages of Allergic Bronchopulmonary Aspergillosis
Official title: A Randomized Trial of Itraconazole in Acute Stages of Allergic Bronchopulmonary Aspergillosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Allergic Bronchopulmonary Aspergillosis
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
First posted: 2015-05-12
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study evaluates the addition of itraconazole to glucocorticoids in management of acute stages of allergic bronchopulmonary aspergillosis (ABPA). Half of the participants will receive glucocorticoids while the other half will receive itraconazole and glucocorticoids

Detailed description: The management of allergic bronchopulmonary aspergillosis (ABPA) includes two important aspects namely institution of immunosuppressive therapy in the form of glucocorticoids to control the immunologic activity, and close monitoring for detection of relapses. Another possible target is to use antifungal agents to attenuate the fungal burden secondary to the fungal colonization in the airways. Oral corticosteroids are currently the treatment of choice for ABPA associated with bronchial asthma. They not only suppress the immune hyperfunction but are also anti-inflammatory.

Itraconazole, an oral triazole with relatively low toxicity, is active against Aspergillus spp. in vitro and in vivo. The activity of itraconazole against Aspergillus spp. is more than that of ketoconazole. The administration of itraconazole can eliminate Aspergillus in the airways and can theoretically reduce the allergic responses in ABPA. We hypothesize that itraconazole when given in the acute stages of ABPA will decrease the chances of relapse and progression to glucocorticoid-dependent ABPA.

Eligibility criteria: Inclusion Criteria:

Treatment naive patients of allergic bronchopulmonary aspergillosis (ABPA) defined by the presence of all the following:

* asthma
* immediate cutaneous hyperreactivity on Aspergillus skin test or A.fumigatus specific IgE levels \>0.35 kUA/L
* elevated total IgE levels \>1000 IU/mL and, two of the following features:
* presence of precipitating antibodies against A.fumigatus in serum
* fixed or transient radiographic pulmonary opacities
* total eosinophil count \>1000/µL
* bronchiectasis on HRCT chest

Exclusion Criteria:

* Intake of systemic glucocorticoids for more than three weeks in the preceding six months
* Exposure to azoles in the last six months
* Immunosuppressive states such as uncontrolled diabetes mellitus, chronic renal failure, chronic liver failure and others
* Patient on immunosuppressive drugs
* Pregnancy
* Enrollment in another trial of ABPA
* Failure to provide informed consent

Primary outcomes:
measure: Relapse rates
timeFrame: 12 months
measure: Glucocorticoid-dependent ABPA
timeFrame: 24 months
Secondary outcomes:
measure: Proportion of patients with a response rates
timeFrame: Six weeks
measure: Percentage decline in IgE
timeFrame: Six weeks
measure: Time to first relapse
timeFrame: Two years
measure: Treatment-related adverse effects
timeFrame: Six months
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Chest Clinic, PGIMER
Study officials:
References: