Efficacy Study of Azithromycin-based Therapy for Bronchiolitis Obliterans

Graft vs Host Disease Clinical Trial

Official title: A Pilot Study Evaluating the Efficacy of Azithromycin, N-acetylcystein and Inhaled Corticosteroid Combination Therapy for Bronchiolitis Obliterans After Allogeneic Hematopoietic Cell Transpantation

Status Terminated

Clinical Trial Summary

[Study Objectives]

• To evaluate the efficacy of azithromycin, N-acetylcystein, and inhaled corticosteroid combination therapy in patients with bronchiolitis obliterans as a complication of allogeneic hematopoietic cell transplantation in terms of response rate at 6 months after treatment initiation based on the improvement of FEV1.

Clinical Trial Description

• Bronchiolitis obliterans (BO) is a graft-versus-host disease of respiratory organs.

• Prognosis of BO is very poor, and the overall outcome of patients who are involved in BO is very dismal.

• The mechanism of BO has been known to be associated with immune / non-immune response.

• Corticosteroid and immunosuppressants are recommended as a best current treatment options for BO, which have been not satisfactory.

• Many treatment options have been tried to improve the outcome of BO.

• Azithromycin, as an immune modulating agent, has been tried for the treatment of BO, and has been reported to show hopeful results.

• N-acetylcystein, as an antioxidative agent, has been tried for BO.

• Inhaled corticosteroid may help to improve airway inflammation and decrease the amount of systemic corticosteroid.

• These 3 drugs are widely used for other respiratory disease, have been proven to be safe, and have shown some efficacy for BO in various depth of evidence.

• In these rationale, we'd like to try the 3-drug combination for BO, to assess the efficacy and safety of these drug combination. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis
• Bronchiolitis Obliterans
• Graft vs Host Disease

• NCT number: NCT01327625
• Study type: Interventional
• Source: Asan Medical Center
• Status: Terminated
• Phase: N/A
• Start date: March 2011
• Completion date: June 2013