Efficacy Study of Azithromycin-based Therapy for Bronchiolitis Obliterans

Asan Medical Center

Status

Terminated

Conditions

Bronchiolitis Obliterans

Graft vs Host Disease

Treatments

Drug: azithromycin + N-acetylcystein + inhaled corticosteroid

Study type

Interventional

Funder types

Other

Identifiers

AMC-ALLO-041

Details and patient eligibility

About

[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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

15 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who previously received allogeneic hematopoietic cell transplantation due to hematologic malignancy, bone marrow failure syndrome, and other compatible disease.
Patients who are diagnosed as bronchiolitis obliterans (BO) according to the NIH diagnostic guideline which is suggested as below.
Patients should be 15 years of age or older, but younger than 75 years.
Patients should have estimated life expectancy of more than 3 months.
Patients must have adequate hepatic function (bilirubin less than 3.0 ㎎/㎗, AST and ALT less than three times the upper normal limit).
Patients must have adequate renal function (creatinine less than 2.0 ㎎/㎗).

Exclusion criteria

Presence of significant active infection
Presence of uncontrolled bleeding
Any coexisting major illness or organ failure
Patients with a psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible.
Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)