Trial record 3 of 31 for:    Open Studies | "Aspergillosis"

Voriconazole Versus Oral Steroids in Allergic Bronchopulmonary Aspergillosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Postgraduate Institute of Medical Education and Research
Sponsor:
Collaborator:
Cipla Ltd.
Information provided by (Responsible Party):
Ritesh Agarwal, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01621321
First received: June 12, 2012
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

This is a research project to evaluate the efficacy and safety of two different treatment protocols in Allergic bronchopulmonary Aspergillosis.


Condition Intervention Phase
Allergic Bronchopulmonary Aspergillosis
Drug: Prednisolone
Drug: Voriconazole
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Voriconazole 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:
  • Response rates in the two groups [ Time Frame: Six weeks and three months ] [ Designated as safety issue: No ]
    IgE levels decline by >=25 percent and there is clinical improvement with partial/total clearance of chest radiographic lesions [if pulmonary opacities have been previously present] after six and three months of treatment

  • Relapse rates in the two groups [ Time Frame: 12, 18, 24 months ] [ Designated as safety issue: No ]
    No ABPA exacerbations over the next 3 months after stopping therapy


Secondary Outcome Measures:
  • Number of Participants with Adverse Events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
    Adverse events in the two groups


Estimated Enrollment: 50
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Steroid group Drug: Prednisolone
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. Patients will also receive inhaled formoterol/fluticasone (6/125 mcg) 1 puff BD and as needed as per the SMART approach for control of asthma
Experimental: Voriconazole group Drug: Voriconazole
Voriconazole 200 mg BD for 4 months. Patients will also receive inhaled formoterol/fluticasone (6/125 mcg) 1 puff BD and as needed as per the SMART approach for control of asthma
Other Name: Voritek 200 mg twice daily for four months

Detailed Description:

Allergic bronchopulmonary aspergillosis (ABPA) is a pulmonary disorder caused by a complex hypersensitivity response to antigens released by the fungus Aspergillus fumigatus. The management of ABPA includes two important aspects - 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. However, there is no data to guide the dose and duration of glucocorticoids and different regimens of glucocorticoids have been used in literature.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. The new triazoles, such as voriconazole, have recently been found effective in the treatment of fungal infections. The investigators hypothesize that voriconazole might also be useful in the treatment of ABPA. The aim of this prospective randomized controlled trial (RCT) is to evaluate the efficacy and safety of voriconazole therapy in patients with ABPA.

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Presence of all the following three criteria:

  • Immediate cutaneous hyperreactivity on aspergillus skin test
  • Elevated total IgE levels > 1000 IU/mL
  • A fumigatus specific IgE levels > 0.35 kUA/L

And, two of the following criteria:

  • Presence of serum precipitating antibodies against A fumigatus
  • Fixed or transient radiographic pulmonary opacities
  • Total eosinophil count > 1000/µL
  • Central bronchiectasis on HRCT

Exclusion Criteria:

  • Failure to give informed consent
  • Intake of glucocorticoids for more than three weeks in the preceding six months
  • Enrollment in another trial of ABPA
  • Any exposure to azoles in the last six months
  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: NCT01621321

Contacts
Contact: Ritesh Agarwal, MD, DM +911722756825 agarwal.ritesh@pgimer.edu.in

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

No publications provided

Responsible Party: Ritesh Agarwal, Associate Professor, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01621321     History of Changes
Other Study ID Numbers: ABPA/003
Study First Received: June 12, 2012
Last Updated: May 13, 2013
Health Authority: India: Institutional Review Board

Additional relevant MeSH terms:
Aspergillosis
Aspergillosis, Allergic Bronchopulmonary
Pulmonary Aspergillosis
Mycoses
Lung Diseases, Fungal
Lung Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Respiratory Tract Infections
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Voriconazole
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics

ClinicalTrials.gov processed this record on July 29, 2014