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Status unknownNCT03467035Updated Mar 15, 2018

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

An observational study in Bronchiectasis Adult and Osteoporosis, Osteopenia, sponsored by Chun-Hua Wang, MD. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-03-15.

Sponsored by Chun-Hua Wang, MD · Observational

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
20 Years and older
Sex
All
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Study summary

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.

Read the 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.

02

Conditions studied

  • Bronchiectasis Adult
  • Osteoporosis, Osteopenia
03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • 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

Interventions

  • OtherInflammasone

    Serum level of cytokine and RT-PCR for PBMC

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What researchers measure

Primary outcomes

  1. six minute walk test

    six minute walk test distance

    Time frame: 6 months

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Study locations

1 of 1 sites recruiting
  • Chang Gung Memorial Hospital
    Taipei, 333, Taiwan
    Recruiting
07

References and documents

Publications

  • Cole PJ. Inflammation: a two-edged sword--the model of bronchiectasis. Eur J Respir Dis Suppl. 1986;147:6-15. PubMed 3533593 ↗
  • Arnett TR. Acidosis, hypoxia and bone. Arch Biochem Biophys. 2010 Nov 1;503(1):103-9. doi: 10.1016/j.abb.2010.07.021. Epub 2010 Jul 23. PubMed 20655868 ↗
  • Utting JC, Flanagan AM, Brandao-Burch A, Orriss IR, Arnett TR. Hypoxia stimulates osteoclast formation from human peripheral blood. Cell Biochem Funct. 2010 Jul;28(5):374-80. doi: 10.1002/cbf.1660. PubMed 20556743 ↗
  • Kim RY, Pinkerton JW, Gibson PG, Cooper MA, Horvat JC, Hansbro PM. Inflammasomes in COPD and neutrophilic asthma. Thorax. 2015 Dec;70(12):1199-201. doi: 10.1136/thoraxjnl-2014-206736. Epub 2015 Oct 22. No abstract available. PubMed 26493990 ↗
  • Diehl N, Johnson MM. Prevalence of Osteopenia and Osteoporosis in Patients with Noncystic Fibrosis Bronchiectasis. South Med J. 2016 Dec;109(12):779-783. doi: 10.14423/SMJ.0000000000000565. PubMed 27911973 ↗
  • McDonnell MJ, Aliberti S, Goeminne PC, Restrepo MI, Finch S, Pesci A, Dupont LJ, Fardon TC, Wilson R, Loebinger MR, Skrbic D, Obradovic D, De Soyza A, Ward C, Laffey JG, Rutherford RM, Chalmers JD. Comorbidities and the risk of mortality in patients with bronchiectasis: an international multicentre cohort study. Lancet Respir Med. 2016 Dec;4(12):969-979. doi: 10.1016/S2213-2600(16)30320-4. Epub 2016 Nov 16. PubMed 27864036 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03467035
Lead sponsor
Chun-Hua Wang, MD
Responsible party
Chun-Hua Wang, MD (professor, Chang Gung Memorial Hospital) — Sponsor-investigator
First posted
Mar 15, 2018
Start date
Dec 21, 2017
Primary completion
Dec 31, 2018 (estimated)
Completion
Jun 30, 2019 (estimated)
Last update
Mar 15, 2018

Study contacts

Hung-Yu Huang, MD
Contact
b9202071@cgmh.org.tw
033281200 ext. 8470
Chun-Hua Wang, MD
Contact
wchunhua@ms7.hinet.net
033281200 ext. 8468
Chun-Hua Wang
study director · Chang Chung Memorial Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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