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

NCT ID: NCT03467035

Last Updated: 2018-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-21

Study Completion Date

2019-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Bronchiectasis Adult Osteoporosis, Osteopenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Inflammasone

Intervention Type OTHER

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

Inflammasone

Intervention Type OTHER

Serum level of cytokine and RT-PCR for PBMC

Interventions

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Inflammasone

Serum level of cytokine and RT-PCR for PBMC

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chun-Hua Wang, MD

OTHER

Sponsor Role lead

Responsible Party

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Chun-Hua Wang, MD

professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Chun-Hua Wang

Role: STUDY_DIRECTOR

Chang Chung Memorial Hospital

Locations

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Chang Gung Memorial Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hung-Yu Huang, MD

Role: CONTACT

033281200 ext. 8470

Chun-Hua Wang, MD

Role: CONTACT

033281200 ext. 8468

Facility Contacts

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Hung-Yu Huang, MD

Role: primary

033281200 ext. 8470

References

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Cole PJ. Inflammation: a two-edged sword--the model of bronchiectasis. Eur J Respir Dis Suppl. 1986;147:6-15.

Reference Type BACKGROUND
PMID: 3533593 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20655868 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20556743 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26493990 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27911973 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27864036 (View on PubMed)

Other Identifiers

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201701317A3

Identifier Type: -

Identifier Source: org_study_id

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