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NCT Number: NCT01621321

Voriconazole Versus Oral Steroids in Allergic Bronchopulmonary Aspergillosis

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

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Key information

Conditions

Allergic Bronchopulmonary Aspergillosis Aspergillosis Aspergillosis, Allergic Bronchopulmonary Bacterial Infections and Mycoses Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lung Diseases Lung Diseases, Fungal Mycoses Pulmonary Aspergillosis Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections

Age range

15 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisolone

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

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

Other names: Voritek 200 mg twice daily for four months

Primary outcomes

  1. 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

  2. Relapse rates in the two groups

    Time frame: 12, 18, 24 months

    No ABPA exacerbations over the next 3 months after stopping therapy

Secondary outcomes

  1. Number of Participants with Adverse Events

    Time frame: 4 months

    Adverse events in the two groups

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Collaborators

  • Cipla Ltd.

Registry information

Official study title

A Randomized Controlled Trial of Voriconazole in Allergic Bronchopulmonary Aspergillosis

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 18, 2012
Registry last updated
Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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