NCT02491723

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 3, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

July 3, 2015

Last Update Submit

October 12, 2016

Conditions

Bronchiectasis

Outcome Measures

Primary Outcomes (1)

  • IL-18 in plasma

    after 3-5 days treatment of Azithromycin immediately

Study Arms (1)

Azithromycin group

EXPERIMENTAL

Patients with non-cystic bronchiectasis were treated with azithromycin. The intervention was 500mg daily for three to five days.

Drug: Azithromycin

Interventions

AzithromycinDRUG

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

Also known as: macrolide
Azithromycin group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to provide written informed consent.
  • Confirmed diagnosis of bronchiectasis by HRCT.
  • Aged 18-85 years.

You may not qualify if:

  • Bronchiectasis as a result of CF or active tuberculosis or non-tuberculous mycobacterial (NTM) infection.
  • Allergy to macrolide antibiotics
  • Any history of severe cardiopulmonary dysfunction, eg. left heart failure, Unstable cardiac arrhythmias
  • pregnant or nursing
  • hypogammaglobulinemia or other autoimmune disease 6. diagnosed with ABPA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Bronchiectasis

Interventions

AzithromycinMacrolides

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ErythromycinPolyketidesLactonesOrganic ChemicalsMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • Jin-Fu Xu, PhD

    Shanghai Pulmonary Hospital, Shanghai, China

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
deputy director

Study Record Dates

First Submitted

July 3, 2015

First Posted

July 8, 2015

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

October 14, 2016

Record last verified: 2016-10

Locations

CN(1)