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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02491723
Other study ID # 20150619
Secondary ID
Status Completed
Phase N/A
First received July 3, 2015
Last updated October 12, 2016
Start date January 2014
Est. completion date January 2016

Study information

Verified date October 2016
Source Shanghai Pulmonary Hospital, Shanghai, China
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

It is acknowledged that IL-18, as a product of the inflammasome, is involved in host defence against viral and bacterial stimuli by modulating the immune response. The aim of this study was to determine IL-18 levels in serum of patients with Bronchiectasis and to investigate whether macrolide attenuate its levels.


Description:

Non-cystic fibrosis bronchiectasis is a respiratory disease characterized by persistent airway inflammation and dilation of bronchial wall driven by various causes. Patients with bronchiectasis suffer from excessive sputum production, recurrent exacerbations, and progressive airway destruction. It was reported that 30%-40% patients were infected with Pseudomonas aeruginosa. Major therapy for bronchiectasis is focused on breaking the "vicious cycle" of mucus stasis, infection, inflammation, and airway destruction. Currently a number of clinical trials have showed that macrolide effectively used in the treatment of non-CF bronchiectasis. Evidence has indicated that 14- and 15-membered ring macrolides possess immunomodulation and anti-inflammatory functions beyond their antimicrobial properties. However, the underlying mechanisms that account for the anti-inflammatory actions of macrolides have not yet to be elucidated, and the activities do not appear to be controlled by a single mechanism.Interleukin-18 (IL-18), along with interleukin-1b (IL-1b), is produced by inflammasomes when activated by a number of pathogen, environmental or host-derived danger signals. Inflammasomes are innate immune regulatory protein complexes which seem to play a key role in the host immune response of patients with Bronchiectasis. The aim of this study was to determine IL-18 levels in serum of patients with Bronchiectasis and to investigate whether macrolide could attenuate its levels.


Recruitment information / eligibility

Status Completed
Enrollment 71
Est. completion date January 2016
Est. primary completion date January 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

1. Able to provide written informed consent.

2. Confirmed diagnosis of bronchiectasis by HRCT.

3. Aged 18-85 years.

Exclusion Criteria:

1. Bronchiectasis as a result of CF or active tuberculosis or non-tuberculous mycobacterial (NTM) infection.

2. Allergy to macrolide antibiotics

3. Any history of severe cardiopulmonary dysfunction, eg. left heart failure, Unstable cardiac arrhythmias

4. pregnant or nursing

5. hypogammaglobulinemia or other autoimmune disease 6. diagnosed with ABPA

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Azithromycin
Patients with bronchiectasis treated with Azithromycin for three to five days.

Locations

Country Name City State
China Shanghai Pulmonary Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Jin-Fu Xu

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary IL-18 in plasma after 3-5 days treatment of Azithromycin immediately Yes
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