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

This study has been completed.
Sponsor:
Information provided by:
Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT00974766
First received: September 9, 2009
Last updated: April 15, 2011
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Allergic Bronchopulmonary Aspergillosis
Drug: Glucocorticoids
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial on the Efficacy and Safety of Two Different Glucocorticoid Dose Regimens in Allergic Bronchopulmonary Aspergillosis

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • remission rates in the two groups at six weeks and three months [ Time Frame: one year ] [ Designated as safety issue: No ]
  • percentage decline in IgE levels at six weeks and three months [ Time Frame: one year ] [ Designated as safety issue: No ]
  • complete remission rates in the two groups [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • relapse rates in the two groups at six and 12 months after completion of glucocorticoid therapy [ Time Frame: two years ] [ Designated as safety issue: No ]
  • glucocorticoid related adverse effects in the two groups [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Low-dose glucocorticoid
Low-dose steroid
Drug: Glucocorticoids
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
Active Comparator: High-dose glucocorticoid
High-dose steroid
Drug: Glucocorticoids
Prednisolone 0.75 mg/kg/day for 6 weeks; then 0.5 mg/kg/day for 6 weeks. Then taper by 5 mg every 6 weeks and discontinue

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974766

Locations
India
Postgraduate Institute of Medical Education and Research
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Ritesh Agarwal, MD, DM Postgraduate Institute of Medical Education and Research, Chandigarh, India
  More Information

No publications provided

Responsible Party: Dr Ritesh Agarwal, Postgraduate Institute of Medical Education and Research, Chandigarh, India
ClinicalTrials.gov Identifier: NCT00974766     History of Changes
Other Study ID Numbers: MS/723/Res/276
Study First Received: September 9, 2009
Last Updated: April 15, 2011
Health Authority: India: Ethics Committee

Keywords provided by Postgraduate Institute of Medical Education and Research:
bronchial asthma
allergic bronchopulmonary aspergillosis

Additional relevant MeSH terms:
Aspergillosis
Aspergillosis, Allergic Bronchopulmonary
Pulmonary Aspergillosis
Dermatomycoses
Hyalohyphomycosis
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Infection
Lung Diseases
Lung Diseases, Fungal
Mycoses
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Skin Diseases
Skin Diseases, Infectious
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014