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Efficacy Study of Azithromycin-based Therapy for Bronchiolitis Obliterans

Information source: Asan Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Graft vs Host Disease; Bronchiolitis Obliterans

Intervention: azithromycin + N-acetylcystein + inhaled corticosteroid (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Asan Medical Center

Official(s) and/or principal investigator(s):
Dae-Young Kim, M.D., Principal Investigator, Affiliation: Asan Medical Center

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 Details

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

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

Primary outcome: Response rate based on the improvement of FEV1

Secondary outcome:

Clinical benefit rate based on the degree of change in FEV1

change in FEV1 compared with pretreatment level

Reduction rate in immunosuppressive agent / systemic corticosteroid

Discontinuation rate in immunosuppressive agent / systemic corticosteroid

Change in dose-intensity of immunosuppressive agent / systemic corticosteroid compared with pretreatment dose-intensity

event-free survival

overall survival

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.

Eligibility

Minimum age: 15 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Asan Medical Center, Seoul 138-736, Korea, Republic of
Additional Information

Related publications:

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Starting date: March 2011
Last updated: July 8, 2014

Page last updated: August 23, 2015

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