NCT01327625

Efficacy Study of Azithromycin-based Therapy for Bronchiolitis Obliterans

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 15 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Graft vs Host Disease
• Bronchiolitis Obliterans

Interventions

Type	Name	Description
DRUG	azithromycin + N-acetylcystein + inhaled corticosteroid	* Azithromycin 500mg qd x 1 week --\> 250mg qod x 6 months * N-acetylcystein 200mg tid x 6 months * Fluticasone 250mcg puff x2/day x 6 months

Timeline

• Start date: 2011-03-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-04-01
• Last updated: 2014-07-09

Locations

1 site across 1 country: South Korea