Clinical trial NCT00974766: Trial on the Efficacy and Safety of Two Different Glucocorticoid Dose Regimens in Allergic Bronchopulmonary Aspergillosis
Official title: Randomized Controlled Trial on the Efficacy and Safety of Two Different Glucocorticoid Dose Regimens in Allergic Bronchopulmonary Aspergillosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Allergic Bronchopulmonary Aspergillosis
Keywords: bronchial asthma
allergic bronchopulmonary aspergillosis
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2009-09-10
Enrollment: 92
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of ABPA
* Presence of all the following three criteria:

  1. immediate cutaneous hyperreactivity on aspergillus skin test
  2. elevated total IgE levels \> 1000 IU/mL
  3. A fumigatus specific IgE levels \> 0.35 kU/L, AND,
* Presence of two of the following criteria:

  1. presence of serum precipitating antibodies against A fumigatus
  2. fixed or transient radiographic pulmonary opacities
  3. absolute eosinophil count \> 1000/µL
  4. 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

Primary outcomes:
measure: Glucocorticoid-dependent ABPA
timeFrame: two year
measure: relapse rates in the two groups
timeFrame: one year
Secondary outcomes:
measure: time to first relapse
timeFrame: one year
measure: glucocorticoid related adverse effects in the two groups
timeFrame: two years
measure: response rates in the two groups
timeFrame: six weeks
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Postgraduate Institute of Medical Education and Research
Study officials:
affiliation: Postgraduate Institute of Medical Education and Research, Chandigarh, India
name: Ritesh Agarwal, MD, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Agarwal R, Aggarwal AN, Dhooria S, Singh Sehgal I, Garg M, Saikia B, Behera D, Chakrabarti A. A randomised trial of glucocorticoids in acute-stage allergic bronchopulmonary aspergillosis complicating asthma. Eur Respir J. 2016 Feb;47(2):490-8. doi: 10.1183/13993003.01475-2015. Epub 2015 Nov 19.