Clinical trial NCT01621321: Voriconazole Versus Oral Steroids in Allergic Bronchopulmonary Aspergillosis
Official title: A Randomized Controlled Trial of Voriconazole in Allergic Bronchopulmonary Aspergillosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Allergic Bronchopulmonary Aspergillosis
Lead sponsor: PGIMER
Sponsor class: UNKNOWN
Collaborators: name: Cipla Ltd.
First posted: 2012-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a research project to evaluate the efficacy and safety of two different treatment protocols in Allergic bronchopulmonary Aspergillosis.

Detailed description: Allergic bronchopulmonary aspergillosis (ABPA) is a pulmonary disorder caused by a complex hypersensitivity response to antigens released by the fungus Aspergillus fumigatus. The management of ABPA includes two important aspects - 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. However, there is no data to guide the dose and duration of glucocorticoids and different regimens of glucocorticoids have been used in literature.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. The new triazoles, such as voriconazole, have recently been found effective in the treatment of fungal infections. The investigators hypothesize that voriconazole might also be useful in the treatment of ABPA. The aim of this prospective randomized controlled trial (RCT) is to evaluate the efficacy and safety of voriconazole therapy in patients with ABPA.

Eligibility criteria: Inclusion Criteria:

Presence of all the following three criteria:

* Immediate cutaneous hyperreactivity on aspergillus skin test
* Elevated total IgE levels \> 1000 IU/mL
* A fumigatus specific IgE levels \> 0.35 kUA/L

And, two of the following criteria:

* Presence of serum precipitating antibodies against A fumigatus
* Fixed or transient radiographic pulmonary opacities
* Total eosinophil count \> 1000/µL
* Central bronchiectasis on HRCT

Exclusion Criteria:

* Failure to give informed consent
* Intake of glucocorticoids for more than three weeks in the preceding six months
* Enrollment in another trial of ABPA
* Any exposure to azoles in the last six months

Primary outcomes:
measure: Response rates in the two groups
timeFrame: Six weeks and three months
measure: Relapse rates in the two groups
timeFrame: 12, 18, 24 months
Secondary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: 4 months
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
Study officials:
References:
citation: Agarwal R, Dhooria S, Sehgal IS, Aggarwal AN, Garg M, Saikia B, Chakrabarti A. A randomised trial of voriconazole and prednisolone monotherapy in acute-stage allergic bronchopulmonary aspergillosis complicating asthma. Eur Respir J. 2018 Sep 18;52(3):1801159. doi: 10.1183/13993003.01159-2018. Print 2018 Sep. No abstract available.