A Randomized Controlled Trial of Inhaled Amphotericin B for Maintaining Remission in Allergic Bronchopulmonary Aspergillosis

NCT01857479 | Completed Phase 2 DMC

• 1 other identifier: NK/708/Res/181
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Inhaled amphotericin, a antifungal drug would decrease Aspergillus colonization and decrease the occurrence of exacerbations of Allergic Bronchopulmonary Aspergillosis (ABPA).

Conditions

Allergic Bronchopulmonary Aspergillosis

Keywords

ABPA

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• ACQ-7 scores between the two groups

  2, 4, 6, and 12 months

• Number of asthma exacerbations requiring oral steroids

  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

Study Arms (2)

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 \[max 10 puff/day\]

Drug: Inhaled budesonide

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.

Drug: Inhaled budesonide; Drug: Inhaled amphotericin

Interventions

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.

Inhaled budesonide; Inhaled budesonide plus amphotericin

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.

Inhaled budesonide plus amphotericin

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Failure to provide informed consent
• Pregnancy
• Involved in any other research protocol

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Chest Clinic, PGIMER

Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Aspergillosis, Allergic Bronchopulmonary

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Lung Diseases, Fungal; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 13, 2013
• First Posted: May 20, 2013
• Study Start: May 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 5, 2015

Record last verified: 2015-08

Locations

IN (1)