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

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ClinicalTrials.gov Identifier: NCT03467035
Recruitment Status : Recruiting
First Posted : March 15, 2018
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Chun-Hua Wang, MD, Chang Gung Memorial Hospital

Brief 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.

Condition or disease Intervention/treatment
Bronchiectasis Adult Osteoporosis, Osteopenia Other: Inflammasone

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 [Patient Registry]
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Role of NLRP3 Inflammasone and Hypoxia in the Severity of Osteoporosis in Patients With Bronchiectasis
Actual Study Start Date : December 21, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis

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




Primary Outcome Measures :
  1. six minute walk test [ Time Frame: 6 months ]
    six minute walk test distance


Biospecimen Retention:   Samples With DNA
The remaining samples after the completion of this study are deposited in the Human Genome Database of Chang Gung Memorial Medical Center _ Linkou __ Chang Gung Memorial Hospital for the follow-up study (including gene research) approved by the Human Ethics Committee of the Hospital


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03467035


Contacts
Contact: Hung-Yu Huang, MD 033281200 ext 8470 b9202071@cgmh.org.tw
Contact: Chun-Hua Wang, MD 033281200 ext 8468 wchunhua@ms7.hinet.net

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Taipei, Taiwan, 333
Contact: Hung-Yu Huang, MD    033281200 ext 8470    b9202071@cgmh.org.tw   
Sponsors and Collaborators
Chun-Hua Wang, MD
Investigators
Study Director: Chun-Hua Wang Chang Chung Memorial Hospital

Publications:
Responsible Party: Chun-Hua Wang, MD, professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03467035     History of Changes
Other Study ID Numbers: 201701317A3
First Posted: March 15, 2018    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Osteoporosis
Hypoxia
Bronchiectasis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Bronchial Diseases
Respiratory Tract Diseases