Bronchiectasis AdultNCT03467035
Role of NLRP3 Inflammasone and Hypoxia in the Severity of Osteoporosis in Patients With Bronchiectasis
An observational study of Bronchiectasis Adult and Osteoporosis, Osteopenia, run by Chun-Hua Wang, MD at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bronchiectasis Adult, Osteoporosis, Osteopenia
- What is being tested?
- Inflammasone
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Dec 2017to 30 Jun 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- willing to sign a written consent form
- Male and female subjects with bronchiectasis diagnosed by high-resolution computed tomography
- willing to accept 6-minute exercise pulmonary function test and blood draw
- Men and women over the age of 20
- Has undergone chest computed tomography and bone density examination in the recent five years
Who cannot join
- pregnant women or lactating women
- asthma, lung resection history before the screening period
- active Tuberculosis infection
- Have received oral steroid treatment within 30 days
- current acute attack or clinical symptoms instability of bronchiectasis
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taipei, 333
Hung-Yu Huang, MD, 033281200 ext. 8470, b9202071@cgmh.org.tw
About this study
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.
- Conditions
- Bronchiectasis Adult, Osteoporosis, Osteopenia
- Being tested
- Inflammasone
- Medical subject headings
- Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InflammasoneOther
Serum level of cytokine and RT-PCR for PBMC
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Inflammasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
six minute walk test
six minute walk test distance
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2018
- Study start21 Dec 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Chun-Hua Wang, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chun-Hua Wang, MD, Chang Gung Memorial Hospital
- Investigators
- Chun-Hua Wang, Study director, Chang Chung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467035
- Sponsor's protocol ID
- 201701317A3
- Status last verified
- Mar 2018
- First submitted
- 7 Mar 2018
- Last updated
- 15 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cole PJ. Inflammation: a two-edged sword--the model of bronchiectasis. Eur J Respir Dis Suppl. 1986;147:6-15.
PubMed 3533593Arnett 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 20655868Utting 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 20556743Kim 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 26493990Diehl 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 27911973McDonnell 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of NLRP3 Inflammasone and Hypoxia in the Severity of Osteoporosis in Patients With Bronchiectasis
- ClinicalTrials.gov ID
- NCT03467035
- Acronym / sponsor ID
- 201701317A3
- Conditions
- Bronchiectasis Adult, Osteoporosis, Osteopenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chun-Hua Wang, MDUniversity, hospital or other
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 15 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| desaturation | – | Other: InflammasoneΔSpO2 >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 |
| non-desaturation | – | Other: InflammasoneΔSpO2 <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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- willing to sign a written consent form
- Male and female subjects with bronchiectasis diagnosed by high-resolution computed tomography
- willing to accept 6-minute exercise pulmonary function test and blood draw
- Men and women over the age of 20
- Has undergone chest computed tomography and bone density examination in the recent five years
Key exclusion criteria (5 listed)
- pregnant women or lactating women
- asthma, lung resection history before the screening period
- active Tuberculosis infection
- Have received oral steroid treatment within 30 days
- current acute attack or clinical symptoms instability of bronchiectasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InflammasoneSerum level of cytokine and RT-PCR for PBMC | Other | desaturation, non-desaturation |
Primary outcome
six minute walk test
Time frame: 6 months
six minute walk test distance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2018.
- Background: PubMed 3533593Cole PJ. Inflammation: a two-edged sword--the model of bronchiectasis. Eur J Respir Dis Suppl. 1986;147:6-15.
- Background: PubMed 20655868Arnett 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.
- Background: PubMed 20556743Utting 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.
- Background: PubMed 26493990Kim 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.
- Background: PubMed 27911973Diehl 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.
- Background: PubMed 27864036McDonnell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun-Hua Wang study director
Chang Chung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis Adult and Osteoporosis, Osteopenia, run by Chun-Hua Wang, MD at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hung-Yu Huang, MD (033281200 ext. 8470, b9202071@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
six minute walk test (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03467035, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2018.