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NCT Number: NCT00974766

Trial on the Efficacy and Safety of Two Different Glucocorticoid Dose Regimens in Allergic Bronchopulmonary Aspergillosis

Allergic bronchopulmonary aspergillosis (ABPA) is a pulmonary disorder caused by a complex hypersensitivity response to antigens released by the fungus Aspergillus fumigatus. 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. The disorder is highly prevalent in India. The investigators have previously reported their experience with screening stable outpatients with bronchial asthma and acute severe asthma for ABPA. The investigators have also recently reported the prognostic factors associated with clinical outcomes in patients with ABPA.

The aim of this prospective randomized controlled trial (RCT) is to evaluate the efficacy and safety of two different glucocorticoid dose protocols in patients with ABPA.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of ABPA
  • 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 kU/L, AND,
  • Presence of two of the following criteria:
  • presence of serum precipitating antibodies against A fumigatus
  • fixed or transient radiographic pulmonary opacities
  • absolute eosinophil count > 1000/µL
  • central bronchiectasis on HRCT

Exclusion criteria

  • If they have taken glucocorticoids for more than three weeks in the preceding six months
  • Failure to give informed consent
  • Enrollment in another trial of ABPA

Treatment and study plan

Glucocorticoids

Drug

Prednisolone 0.5 mg/kg/day for 2 weeks; then 0.5 mg/kg/day for alternate days for eight weeks. Then taper by 5 mg every 2 weeks and discontinue

Primary outcomes

  1. Glucocorticoid-dependent ABPA

    Time frame: two year

  2. relapse rates in the two groups

    Time frame: one year

Secondary outcomes

  1. time to first relapse

    Time frame: one year

  2. glucocorticoid related adverse effects in the two groups

    Time frame: two years

  3. response rates in the two groups

    Time frame: six weeks

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

Randomized Controlled Trial on the Efficacy and Safety of Two Different Glucocorticoid Dose Regimens in Allergic Bronchopulmonary Aspergillosis

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 10, 2009
Registry last updated
Feb 24, 2015

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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