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

Bronchiectasis Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03467035
• Other study ID #: 201701317A3
• Status: Recruiting
• Phase: N/A
• First received: March 7, 2018
• Last updated: March 14, 2018
• Start date: December 21, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: March 2018
• Source: Chang Gung Memorial Hospital
• Contact: Hung-Yu Huang, MD
• Phone: 033281200
• Email: b9202071[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Bronchiectasis
• Bronchiectasis Adult
• Hypoxia
• Osteoporosis
• Osteoporosis, Osteopenia

Intervention

Other:
• Inflammasone
Serum level of cytokine and RT-PCR for PBMC

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Chun-Hua Wang, MD

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

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. Review. — View Citation

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

Diehl N, Johnson MM. Prevalence of Osteopenia and Osteoporosis in Patients with Noncystic Fibrosis Bronchiectasis. South Med J. 2016 Dec;109(12):779-783. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	six minute walk test	six minute walk test distance	6 months