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Inhaled amphotericin, a antifungal drug would decrease Aspergillus colonization and decrease the occurrence of exacerbations of Allergic Bronchopulmonary Aspergillosis (ABPA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled budesonide | Active Comparator | 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] |
|
| Inhaled budesonide plus amphotericin | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled budesonide | Drug | The control group will receive only 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]. The first dose will be administered under direct supervision. If the first dose is tolerated, therapy would be continued for the total duration of the study (4 months). The patient will be advised to clean the nebulizer chamber with soap and water after each administration to avoid contamination. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first relapse | Relapse will be defined as clinical and/or radiological worsening along with 50% increase of the baseline IgE levels | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| ACQ-7 scores between the two groups | 2, 4, 6, and 12 months | |
| Number of asthma exacerbations requiring oral steroids | 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 |
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Inclusion Criteria: ABPA in remission defined as follows:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chest Clinic, PGIMER | Chandigarh | 160012 | India |
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|
| Inhaled amphotericin | Drug | 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. |
|
| 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 |
| ID | Term |
|---|---|
| D001229 | Aspergillosis, Allergic Bronchopulmonary |
| ID | Term |
|---|---|
| D055732 | Pulmonary Aspergillosis |
| D001228 | Aspergillosis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D008172 | Lung Diseases, Fungal |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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