NCT01621321

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2013

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 18, 2012

Completed
12 months until next milestone

Study Start

First participant enrolled

June 1, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

December 12, 2017

Status Verified

December 1, 2017

Enrollment Period

2.8 years

First QC Date

June 12, 2012

Last Update Submit

December 11, 2017

Conditions

Allergic Bronchopulmonary Aspergillosis

Outcome Measures

Primary Outcomes (2)

  • 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

  • Relapse rates in the two groups

    No ABPA exacerbations over the next 3 months after stopping therapy

    12, 18, 24 months

Secondary Outcomes (1)

  • Number of Participants with Adverse Events

    4 months

Study Arms (2)

Steroid group

EXPERIMENTAL
Drug: Prednisolone

Voriconazole group

EXPERIMENTAL
Drug: Voriconazole

Interventions

PrednisoloneDRUG

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

Steroid group
VoriconazoleDRUG

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

Also known as: Voritek 200 mg twice daily for four months
Voriconazole group

Eligibility Criteria

Age15 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

Location

Related Publications (1)

  • 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.

    PMID: 30049743DERIVED

MeSH Terms

Conditions

Aspergillosis, Allergic Bronchopulmonary

Interventions

PrednisoloneVoriconazole

Condition Hierarchy (Ancestors)

Pulmonary AspergillosisAspergillosisMycosesBacterial Infections and MycosesInfectionsLung Diseases, FungalRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 18, 2012

Study Start

June 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

December 12, 2017

Record last verified: 2017-12

Locations

IN(1)