A Randomized Controlled Trial of Inhaled Amphotericin B for Maintaining Remission in Allergic Bronchopulmonary Aspergillosis
Phase 2
Completed
- Conditions
- Allergic Bronchopulmonary Aspergillosis
- Interventions
- Drug: Inhaled amphotericin
- Registration Number
- NCT01857479
- Lead Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Brief Summary
Inhaled amphotericin, a antifungal drug would decrease Aspergillus colonization and decrease the occurrence of exacerbations of Allergic Bronchopulmonary Aspergillosis (ABPA).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21
Inclusion Criteria
ABPA in remission defined as follows:
- Age 12-65 years
- Diagnosis of ABPA in the Chest Clinic
- Received glucocorticoids for management of ABPA according to the Chest clinic protocol (0.5 mg/kg/day for 4 weeks, 0.25 mg/kg/day for 4 weeks, 0.125 mg/kg/day for 4 weeks, subsequently taper and stop steroids over the next 4 weeks).
- Clinicoradiologic improvement with decline in IgE levels. The chest radiograph and IgE levels after four months of steroid therapy would serve as the baseline
Exclusion Criteria
- Failure to provide informed consent
- Pregnancy
- Involved in any other research protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inhaled budesonide plus amphotericin Inhaled budesonide Amphotericin B deoxycholate (50 mg) will be dissolved in 10 mL sterile water for injection (5 mg/mL). The solution remains stable for at least 7 days at 2°C to 8°C. Ten milligrams of the drug (2 mL) will be nebulized over 10-15 minutes twice in a day for three times a week (Effective dose: 10 mg b.i.d. thrice a week) using a jet nebulizer. Nebulized budesonide will be administered at a dose of 1 mg b.i.d. thrice a week after nebulization with amphotericin B. The total duration of therapy would last 4 months. Patients will also receive a metered dose inhaler of formoterol/budesonide (6/200) at a dose of 2 puffs b.i.d. and as and when required \[max 10 puff/day\]. The first dose will be administered under direct supervision. Inhaled budesonide plus amphotericin Inhaled amphotericin Amphotericin B deoxycholate (50 mg) will be dissolved in 10 mL sterile water for injection (5 mg/mL). The solution remains stable for at least 7 days at 2°C to 8°C. Ten milligrams of the drug (2 mL) will be nebulized over 10-15 minutes twice in a day for three times a week (Effective dose: 10 mg b.i.d. thrice a week) using a jet nebulizer. Nebulized budesonide will be administered at a dose of 1 mg b.i.d. thrice a week after nebulization with amphotericin B. The total duration of therapy would last 4 months. Patients will also receive a metered dose inhaler of formoterol/budesonide (6/200) at a dose of 2 puffs b.i.d. and as and when required \[max 10 puff/day\]. The first dose will be administered under direct supervision. Inhaled budesonide Inhaled budesonide Nebulized budesonide 1 mg b.i.d. thrice a week for four months. Patients will also receive a metered dose inhaler of formoterol/budesonide (6/200) at a dose of 2 puffs b.i.d. and as and when required \[max 10 puff/day\]
- Primary Outcome Measures
Name Time Method Time to first relapse 12 months Relapse will be defined as clinical and/or radiological worsening along with 50% increase of the baseline IgE levels
- Secondary Outcome Measures
Name Time Method Number of asthma exacerbations requiring oral steroids 12 months During each exacerbation, chest radiograph and IgE levels will be performed; Asthma exacerbation will be defined as worsening asthma control without radiological changes consistent with ABPA exacerbation and absence of doubling of baseline IgE levels
ACQ-7 scores between the two groups 2, 4, 6, and 12 months Improvement in forced expiratory volume in the first second (FEV1) 2, 4, 6, and 12 months Adverse effects of therapy in both the arms 12 months
Trial Locations
- Locations (1)
Chest Clinic, PGIMER
🇮🇳Chandigarh, India