Efficacy Study of Azithromycin-based Therapy for Bronchiolitis Obliterans

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01327625
• Date of registration: 31/03/2011
• Prospective Registration: No
• Primary sponsor: Asan Medical Center
• Public title: Efficacy Study of Azithromycin-based Therapy for Bronchiolitis Obliterans
• Scientific title: A Pilot Study Evaluating the Efficacy of Azithromycin, N-acetylcystein and Inhaled Corticosteroid Combination Therapy for Bronchiolitis Obliterans After Allogeneic Hematopoietic Cell Transpantation
• Date of first enrolment: March 2011
• Target sample size: 6
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01327625
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Korea, Republic of

Contacts

• Name: Dae-Young Kim, M.D.
• Affiliation: Asan Medical Center

Key inclusion & exclusion 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)



Age minimum: 15 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Bronchiolitis Obliterans

Graft vs Host Disease

Intervention(s)

Drug: azithromycin + N-acetylcystein + inhaled corticosteroid

Primary Outcome(s)

Response rate based on the improvement of FEV1 [Time Frame: 6 months]

Secondary Outcome(s)

Discontinuation rate in immunosuppressive agent / systemic corticosteroid [Time Frame: 6 months after treatment initiation]

change in FEV1 compared with pretreatment level [Time Frame: 6 months after treatment initiation]

Reduction rate in immunosuppressive agent / systemic corticosteroid [Time Frame: 6 months after treatment initiation]

Clinical benefit rate based on the degree of change in FEV1 [Time Frame: 6 months]

Change in dose-intensity of immunosuppressive agent / systemic corticosteroid compared with pretreatment dose-intensity [Time Frame: 6 months after treatment initiation]

event-free survival [Time Frame: 1 year]

overall survival [Time Frame: 1year]

Secondary ID(s)

AMC-ALLO-041

Source(s) of Monetary Support

Please refer to primary and secondary sponsors