Efficacy Study of Azithromycin-based Therapy for Bronchiolitis Obliterans
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|ClinicalTrials.gov Identifier: NCT01327625|
Recruitment Status : Terminated (Preliminary reports of this study was too bad.)
First Posted : April 1, 2011
Last Update Posted : July 9, 2014
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Graft vs Host Disease Bronchiolitis Obliterans||Drug: azithromycin + N-acetylcystein + inhaled corticosteroid||Not Applicable|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||March 2011|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
Patient who are diagnosed as bronchiolitis obliterans according to the WHO criteria
Drug: azithromycin + N-acetylcystein + inhaled corticosteroid
Other Name: Zithromax
- Response rate based on the improvement of FEV1 [ Time Frame: 6 months ]Response rate at 6 months after treatment initiation based on the improvement of FEV1
- Clinical benefit rate based on the degree of change in FEV1 [ Time Frame: 6 months ]Clinical benefit rate at 6 months after treatment initiation based on the degree of change in FEV1
- change in FEV1 compared with pretreatment level [ Time Frame: 6 months after treatment initiation ]Change in FEV1 at 6 months after treatment initiation compared with pretreatment level
- Reduction rate in immunosuppressive agent / systemic corticosteroid [ Time Frame: 6 months after treatment initiation ]Reduction rate in immunosuppressive agent / systemic corticosteroid at 6 months after treatment initiation
- Discontinuation rate in immunosuppressive agent / systemic corticosteroid [ Time Frame: 6 months after treatment initiation ]Discontinuation rate in immunosuppressive agent / systemic corticosteroid at 6 months after treatment initiation
- Change in dose-intensity of immunosuppressive agent / systemic corticosteroid compared with pretreatment dose-intensity [ Time Frame: 6 months after treatment initiation ]Change in dose-intensity of immunosuppressive agent / systemic corticosteroid at 6 month after treatment initiation compared with pretreatment dose-intensity
- event-free survival [ Time Frame: 1 year ]
- overall survival [ Time Frame: 1year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01327625
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Principal Investigator:||Dae-Young Kim, M.D.||Asan Medical Center|