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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00974766
First Posted: September 10, 2009
Last Update Posted: February 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ritesh Agarwal, Postgraduate Institute of Medical Education and Research
  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
Intervention Model: Single Group Assignment
Masking: None (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 Ritesh Agarwal, Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Glucocorticoid-dependent ABPA [ Time Frame: two year ]
  • relapse rates in the two groups [ Time Frame: one year ]

Secondary Outcome Measures:
  • time to first relapse [ Time Frame: one year ]
  • glucocorticoid related adverse effects in the two groups [ Time Frame: two years ]
  • response rates in the two groups [ Time Frame: six weeks ]

Enrollment: 92
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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ritesh Agarwal, Additional Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT00974766     History of Changes
Other Study ID Numbers: MS/723/Res/276
First Submitted: September 9, 2009
First Posted: September 10, 2009
Last Update Posted: February 24, 2015
Last Verified: February 2015

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

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