An observational study in Emphysema, sponsored by McMaster University. Recruiting at 1 site in Canada. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by McMaster University · Observational
The hypothesis is that in patients with emphysema, a high MMP12 sputum and/or blood level correlates with airspace enlargement and with increased sputum Th2 immune biomarkers.
Since MMP-12 apparently has a preponderant role in the genesis of emphysema and probably in airspace enlargement, its inhibition may result in an interesting targeting point in view to find specific therapies in obstructive diseases. There is abundant evidence in animal models that shows how MMP-12 blockade inhibits the development of emphysema and airway remodeling. Unfortunately, the results have not been conclusive in human models.
In the last years, pulmonary imaging biomarkers that measure airspace enlargement have been developed. In particular, the apparent diffusion coefficient (ADC), quantified by inhaled hyperpolarized gas MRI, reflects alveolar airspace size. ADC provides information consistent with histopathological findings that may be used to estimate lung disease progression and treatment response.
382 studies on the registry are indexed under Emphysema; 59 are open to participants now.
This study's planned enrollment of 45 is below the median of 131 across 111 observational studies indexed under Emphysema.
Browse Emphysema studies →McMaster University is the lead sponsor of 741 studies on the registry; 127 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
This is a cross-sectional study in healthy controls and patients with pulmonary emphysema.
Inclusion Criteria ():
Inclusion criteria for normal controls:
Exclusion Criteria:
Any potential subject who meets any of the following criteria will be excluded from participating in the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
blood eosinophils ≥300 cells/μL and sputum eosinophils \>3%
Procedure: Hyperpolarized 129Xe (Xenon) diffusion-weighted MRI
sputum neutrophils \<65% and eosinophils \<3%
Procedure: Hyperpolarized 129Xe (Xenon) diffusion-weighted MRI
sputum neutrophils \>65% and sputum eosinophils \< 3%
Procedure: Hyperpolarized 129Xe (Xenon) diffusion-weighted MRI
Participants will inhale a one litre gas mixture containing hyperpolarized 129Xe mixed with nitrogen (N2) or helium (4He) from a one litre dose bag. Breath-hold will be up to 16 seconds
Blood and sputum matrix metalloproteinase-12 (MMP12) levels
Measure sputum and blood MMP12 levels
Time frame: Baseline
Quantify their alveolar destruction using Computed Tomography (CT) and magnetic resonance imaging (MRI)
The relative area of the Computed Tomography (CT) attenuation histogram with attenuation of 950 HU or less (RA950) and the 15th percentile of the CT attenuation histogram (HU15) will be generated to quantify emphysema. For analysis of 129Xe diffusion-weighted MR images we will employ the same approach as described by Kirby and colleagues to quantify the apparent diffusion coefficient (ADC) and generate ADC maps12 to assess airspace size.
Time frame: Baseline
Measure other T2 activity biomarkers in sputum
Sputum: enumeration of Free eosinophils granules (FEG) by none, few moderate and many
Time frame: Baseline
Measure other T2 activity biomarkers in sputum supernatant
Sputum supernatant: Levels of (interleukin) IL-4, IL-5 and IL-13, eosinophil peroxidase, transforming growth factor (TGF)-beta, Phospho-Smad2 and Phospho-Smad3 (SMAD=Small Mothers Against Decapentaplegic gene)
Time frame: Baseline
Measure other T2 activity biomarkers in blood
Ferritin in microgram per litre (ug/L)
Time frame: Baseline
Measure other T2 activity biomarkers in blood
C reactive protein (CRP) in milligram/litre (mg/L)
Time frame: Baseline
Compare type-2 (T2) activity biomarkers with healthy individuals in sputum
Sputum: enumeration of Free eosinophils granules (FEG) as few, moderate and many.
Time frame: Baseline
Compare type-2 (T2) activity biomarkers with healthy individuals in blood
Ferritin in microgram per litre (ug/L)
Time frame: Baseline
Compare type-2 (T2) activity biomarkers with healthy individuals in blood
C reactive protein (CRP) in milligram/litre (mg/L)
Time frame: Baseline
Compare type-2 (T2) activity biomarkers with healthy individuals in sputum supernatant
Sputum supernatant: Levels of IL-4, IL-5 and IL-13, eosinophil peroxidase, TGF-beta, Phospho-Smad2 and Phospho-Smad3.
Time frame: Baseline
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