Voriconazole Versus Oral Steroids in Allergic Bronchopulmonary Aspergillosis

NCT ID: NCT01621321

Last Updated: 2017-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-04-30

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.

Conditions

Allergic Bronchopulmonary Aspergillosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Steroid group

Group Type: EXPERIMENTAL

Prednisolone

Intervention Type: DRUG

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 group

Group Type: EXPERIMENTAL

Voriconazole

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

Voritek 200 mg twice daily for four months

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cipla Ltd.

INDUSTRY

Sponsor Role: collaborator

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Ritesh Agarwal

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Postgraduate Institute of Medical Education and Research

Chandigarh, , India

Countries

India

References

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.

Reference Type: DERIVED

PMID: 30049743 (View on PubMed)

Other Identifiers

ABPA/003

Identifier Type: -

Identifier Source: org_study_id