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Completed

NCT Number: NCT02440009

A Randomized Trial of Itraconazole in Acute Stages of Allergic Bronchopulmonary Aspergillosis

The study evaluates the addition of itraconazole to glucocorticoids in management of acute stages of allergic bronchopulmonary aspergillosis (ABPA). Half of the participants will receive glucocorticoids while the other half will receive itraconazole and glucocorticoids

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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

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Chest Clinic, PGIMER

Chandigarh, 160012, India

About this study

The management of allergic bronchopulmonary aspergillosis (ABPA) includes two important aspects namely 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.

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. We hypothesize that itraconazole when given in the acute stages of ABPA will decrease the chances of relapse and progression to glucocorticoid-dependent ABPA.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Treatment naive patients of allergic bronchopulmonary aspergillosis (ABPA) defined by the presence of all the following:

  • asthma
  • immediate cutaneous hyperreactivity on Aspergillus skin test or A.fumigatus specific IgE levels >0.35 kUA/L
  • elevated total IgE levels >1000 IU/mL and, two of the following features:
  • presence of precipitating antibodies against A.fumigatus in serum
  • fixed or transient radiographic pulmonary opacities
  • total eosinophil count >1000/µL
  • bronchiectasis on HRCT chest

Exclusion criteria

  • Intake of systemic glucocorticoids for more than three weeks in the preceding six months
  • Exposure to azoles in the last six months
  • Immunosuppressive states such as uncontrolled diabetes mellitus, chronic renal failure, chronic liver failure and others
  • Patient on immunosuppressive drugs
  • Pregnancy
  • Enrollment in another trial of ABPA
  • Failure to provide informed consent

Treatment and study plan

Itraconazole

Drug

Oral itraconazole 200 mg BD for 6 months

Other names: Azole

Glucocorticoids

Drug

Oral 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 by the end of 4 months.

Other names: Steroid

Primary outcomes

  1. Relapse rates

    Time frame: 12 months

    Doubling of the baseline IgE levels irrespective of the patient's symptoms or appearance of radiologic infiltrates; or clinical and/or radiological worsening with 50% increase in IgE over the previous baseline value

  2. Glucocorticoid-dependent ABPA

    Time frame: 24 months

    If the patient has relapse on two or more consecutive occasions within 6 months of stopping treatment or requires oral steroids for control of asthma

Secondary outcomes

  1. Proportion of patients with a response rates

    Time frame: Six weeks

  2. Percentage decline in IgE

    Time frame: Six weeks

  3. Time to first relapse

    Time frame: Two years

  4. Treatment-related adverse effects

    Time frame: Six months

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Acronym: RIA

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 12, 2015
Registry last updated
Oct 7, 2022

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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