Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Voriconazole Versus Oral Steroids in Allergic Bronchopulmonary Aspergillosis

This study has been completed.
Cipla Ltd.
Information provided by (Responsible Party):
Ritesh Agarwal, Postgraduate Institute of Medical Education and Research Identifier:
First received: June 12, 2012
Last updated: January 2, 2017
Last verified: January 2017
This is a research project to evaluate the efficacy and safety of two different treatment protocols in Allergic bronchopulmonary Aspergillosis.

Condition Intervention Phase
Allergic Bronchopulmonary Aspergillosis
Drug: Prednisolone
Drug: Voriconazole
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Voriconazole in Allergic Bronchopulmonary Aspergillosis

Resource links provided by NLM:

Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Response rates in the two groups [ Time Frame: Six weeks and three months ]
    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

  • Relapse rates in the two groups [ Time Frame: 12, 18, 24 months ]
    No ABPA exacerbations over the next 3 months after stopping therapy

Secondary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: 4 months ]
    Adverse events in the two groups

Enrollment: 50
Study Start Date: June 2013
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Steroid group 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
Experimental: Voriconazole group Drug: Voriconazole
Voriconazole 200 mg BD for 6 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
Other Name: Voritek 200 mg twice daily for six months

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.

Ages Eligible for Study:   15 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01621321

Postgraduate Institute of Medical Education and Research
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Cipla Ltd.
  More Information

Responsible Party: Ritesh Agarwal, Associate Professor, Postgraduate Institute of Medical Education and Research Identifier: NCT01621321     History of Changes
Other Study ID Numbers: ABPA/003
Study First Received: June 12, 2012
Last Updated: January 2, 2017

Additional relevant MeSH terms:
Aspergillosis, Allergic Bronchopulmonary
Pulmonary Aspergillosis
Skin Diseases, Infectious
Skin Diseases
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Respiratory Tract Infections
Hypersensitivity, Immediate
Immune System Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors processed this record on May 25, 2017