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Voriconazole Versus Oral Steroids in Allergic Bronchopulmonary Aspergillosis

Sponsor
Postgraduate Institute of Medical Education and Research (Other)
Overall Status
Completed
CT.gov ID
NCT01621321
Collaborator
Cipla Ltd. (Industry)
50
Enrollment
1
Location
2
Arms
34
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Trial of Voriconazole in Allergic Bronchopulmonary Aspergillosis
Study Start Date :
Jun 1, 2013
Actual Primary Completion Date :
Apr 1, 2016
Actual Study Completion Date :
Apr 1, 2016

Arms and Interventions

Arm Intervention/Treatment
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 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
Other Names:
  • Voritek 200 mg twice daily for four months

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Response rates in the two groups [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

    2. Relapse rates in the two groups [12, 18, 24 months]

      No ABPA exacerbations over the next 3 months after stopping therapy

    Secondary Outcome Measures

    1. Number of Participants with Adverse Events [4 months]

      Adverse events in the two groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 65 Years
    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

    Locations

    Site City State Country Postal Code
    1 Postgraduate Institute of Medical Education and Research Chandigarh India 160012

    Sponsors and Collaborators

    • Postgraduate Institute of Medical Education and Research
    • Cipla Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ritesh Agarwal, Associate Professor, Postgraduate Institute of Medical Education and Research
    ClinicalTrials.gov Identifier:
    NCT01621321
    Other Study ID Numbers:
    • ABPA/003
    First Posted:
    Jun 18, 2012
    Last Update Posted:
    Dec 12, 2017
    Last Verified:
    Dec 1, 2017
    Additional relevant MeSH terms:
    Aspergillosis
    Pulmonary Aspergillosis
    Aspergillosis, Allergic Bronchopulmonary
    Voriconazole
    Prednisolone

    Study Results

    No Results Posted as of Dec 12, 2017