Role of NLRP3 Inflammasone and Hypoxia in the Severity of Osteoporosis in Patients With Bronchiectasis

March 14, 2018 updated by: Chun-Hua Wang, MD
The objectives of this research grant are to determine the association of hypoxia with the severity of osteoporosis in the patients with bronchiectasis and whether the mechanism of inflammation is triggered by inflammasones, which makes it more prone to osteoporosis in patients with bronchiectasis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

80 patients with proven bronchiectasis, diagnosed by high-resolution computed tomography (HRCT), will be recruited from our outpatient clinic of Chang Gung Memorial Hospital with written informed consent. Inclusion criteria are: daily sputum > 10 ml; absence of asthma or other unstable systemic diseases; and "steady-state" bronchiectasis (< 10% alteration of 24 h sputum volume, FEV1, and FVC, and in the absence of deterioration in respiratory symptoms at baseline visits). Exclusion criteria include: unreliable clinic attendance; regular user of inhaled or oral corticosteroids; history of lung resection and known asthma defined according to American Thoracic Society guidelines.

The lung function and desaturation will be assessed by six-minute walking tests and the severity of disease will be evaluated by HRCT scores. Peripheral blood sample (40ml/person) is performed to analyze the bone turnover markers and the level of Hif in PBMC.

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 333
        • Recruiting
        • Chang Gung memorial hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

80 adult patients with proven bronchiectasis, diagnosed by high-resolution computed tomography (HRCT), will be recruited from our outpatient clinic of Chang Gung Memorial Hospital with written informed consent. The inclusion and exclusion criteria are described above.

Description

Inclusion Criteria:

  1. willing to sign a written consent form
  2. Male and female subjects with bronchiectasis diagnosed by high-resolution computed tomography
  3. willing to accept 6-minute exercise pulmonary function test and blood draw
  4. Men and women over the age of 20
  5. Has undergone chest computed tomography and bone density examination in the recent five years

Exclusion Criteria:

  1. pregnant women or lactating women
  2. asthma, lung resection history before the screening period
  3. active Tuberculosis infection
  4. Have received oral steroid treatment within 30 days
  5. current acute attack or clinical symptoms instability of bronchiectasis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
desaturation

ΔSpO2 >10% or lowest SpO2<90 during baseline six minute walk test

Check serum level of inflammasone, such as IL-1beta, TGF-beta TRT-PCR for PBMC
Other: Inflammasone
Serum level of cytokine and RT-PCR for PBMC
non-desaturation

ΔSpO2 <10% and lowest SpO2>90 during baseline six minute walk test

Check serum level of inflammasone, such as IL-1beta, TGF-beta TRT-PCR for PBMC
Other: Inflammasone
Serum level of cytokine and RT-PCR for PBMC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
six minute walk test
Time Frame: 6 months
six minute walk test distance
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chun-Hua Wang, MD

Investigators

  • Study Director: Chun-Hua Wang, Chang Chung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2017

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (Actual)

March 15, 2018

Study Record Updates

Last Update Posted (Actual)

March 15, 2018

Last Update Submitted That Met QC Criteria

March 14, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201701317A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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