Voriconazole Versus Oral Steroids in Allergic Bronchopulmonary Aspergillosis
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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 |
- 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
- 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 |
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| Contact: Ritesh Agarwal, MD, DM | +911722756825 | agarwal.ritesh@pgimer.edu.in |
| India | |
| Postgraduate Institute of Medical Education and Research | Recruiting |
| Chandigarh, India, 160012 | |
| Principal Investigator: Ritesh Agarwal, MD, DM | |
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, Allergic Bronchopulmonary Aspergillosis 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 May 23, 2013