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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:
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

September 9, 2009
April 15, 2011
April 2009
March 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00974766 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Trial on the Efficacy and Safety of Two Different Glucocorticoid Dose Regimens in Allergic Bronchopulmonary Aspergillosis
Randomized Controlled 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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Allergic Bronchopulmonary Aspergillosis
  • 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
  • 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
  • Active Comparator: Low-dose glucocorticoid
    Low-dose steroid
    Intervention: Drug: Glucocorticoids
  • Active Comparator: High-dose glucocorticoid
    High-dose steroid
    Intervention: Drug: Glucocorticoids
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00974766
MS/723/Res/276
Yes
Dr Ritesh Agarwal, Postgraduate Institute of Medical Education and Research, Chandigarh, India
Postgraduate Institute of Medical Education and Research
Not Provided
Principal Investigator: Ritesh Agarwal, MD, DM Postgraduate Institute of Medical Education and Research, Chandigarh, India
Postgraduate Institute of Medical Education and Research
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP