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Voriconazole Versus Oral Steroids in Allergic Bronchopulmonary Aspergillosis

Primary Purpose

Allergic Bronchopulmonary Aspergillosis

Status
Completed
Phase
Phase 2
Locations
India
Study Type
Interventional
Intervention
Prednisolone
Voriconazole
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Bronchopulmonary Aspergillosis

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Postgraduate Institute of Medical Education and Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Steroid group

Voriconazole group

Arm Description

Outcomes

Primary Outcome Measures

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
Relapse rates in the two groups
No ABPA exacerbations over the next 3 months after stopping therapy

Secondary Outcome Measures

Number of Participants with Adverse Events
Adverse events in the two groups

Full Information

First Posted
June 12, 2012
Last Updated
December 11, 2017
Sponsor
Postgraduate Institute of Medical Education and Research
Collaborators
Cipla Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01621321
Brief Title
Voriconazole Versus Oral Steroids in Allergic Bronchopulmonary Aspergillosis
Official Title
A Randomized Controlled Trial of Voriconazole in Allergic Bronchopulmonary Aspergillosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
Collaborators
Cipla Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Bronchopulmonary Aspergillosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Steroid group
Arm Type
Experimental
Arm Title
Voriconazole group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Prednisolone
Intervention Description
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
Intervention Name(s)
Voriconazole
Other Intervention Name(s)
Voritek 200 mg twice daily for four months
Intervention Description
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
Primary Outcome Measure Information:
Title
Response rates in the two groups
Description
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
Time Frame
Six weeks and three months
Title
Relapse rates in the two groups
Description
No ABPA exacerbations over the next 3 months after stopping therapy
Time Frame
12, 18, 24 months
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events
Description
Adverse events in the two groups
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Postgraduate Institute of Medical Education and Research
City
Chandigarh
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
30049743
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.
Results Reference
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Voriconazole Versus Oral Steroids in Allergic Bronchopulmonary Aspergillosis

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