Voriconazole Versus Oral Steroids in Allergic Bronchopulmonary Aspergillosis

Allergic Bronchopulmonary Aspergillosis Clinical Trial

Official title:

A Randomized Controlled Trial of Voriconazole in Allergic Bronchopulmonary Aspergillosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01621321
• Other study ID #: ABPA/003
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 12, 2012
• Last updated: December 11, 2017
• Start date: June 2013
• Est. completion date: April 2016

Study information

• Verified date: December 2017
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Bronchopulmonary Aspergillosis
• Aspergillosis
• Pulmonary Aspergillosis

Intervention

Drug:
• Prednisolone
Prednisolone 0.5 mg/kg/day for 4 weeks; 0.25 mg/kg/day for 4 weeks; 0.125 mg/kg/day for 4 weeks. Then taper by 5 mg every 4 weeks and discontinue. Patients will also receive inhaled formoterol/fluticasone (6/125 mcg) 1 puff BD and as needed as per the SMART approach for control of asthma
• Voriconazole
Voriconazole 200 mg BD for 4 months. Patients will also receive inhaled formoterol/fluticasone (6/125 mcg) 1 puff BD and as needed as per the SMART approach for control of asthma

Locations

Country	Name	City	State
India	Postgraduate Institute of Medical Education and Research	Chandigarh

Sponsors (2)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research	Cipla Ltd.

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rates in the two groups	IgE levels decline by >=25 percent and there is clinical improvement with partial/total clearance of chest radiographic lesions [if pulmonary opacities have been previously present] after six and three months of treatment	Six weeks and three months
Primary	Relapse rates in the two groups	No ABPA exacerbations over the next 3 months after stopping therapy	12, 18, 24 months
Secondary	Number of Participants with Adverse Events	Adverse events in the two groups	4 months