Understanding MMP12 levels in patients with emphysema
Characterizing Mmp12 In Sputum And Its Relationship To Emphysema And Inflammatory Endotypes
This study is trying to see if measuring a specific protein in the sputum and blood of people with emphysema can help understand their lung condition and find better treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | McMaster University Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT04761393 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the correlation between levels of matrix metalloproteinase-12 (MMP12) in sputum and blood with airspace enlargement in patients diagnosed with emphysema. The study utilizes hyperpolarized 129Xe diffusion-weighted MRI to measure alveolar airspace size, providing insights into lung disease progression and treatment response. By analyzing sputum and blood samples, researchers hope to identify potential biomarkers that could lead to targeted therapies for obstructive lung diseases.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 40 and older with a history of smoking and a confirmed diagnosis of pulmonary emphysema.
Not a fit: Patients with other significant respiratory disorders or those without a history of smoking may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the identification of new therapeutic targets for emphysema, improving treatment options for patients.
How similar studies have performed: Previous studies in animal models have shown promising results regarding MMP-12 blockade, but human studies have been inconclusive, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (COPD): * ≥40 years of age * Current or ex-smokers with a \>10 pack year smoking history * Have a post-bronchodilator forced expired volume in 1 second (FEV1)/forced expired vital capacity (FVC) ratio of \<70% and a post-bronchodilator FEV1 value from ≥30% predicted (GOLD 1, 2 and 3), (Global Initiative for Obstructive Lung disease) * Have a radiologist confirmed pulmonary emphysema diagnosis based on CT Inclusion criteria for normal controls: * No clinically significant medical condition or a history of asthma, COPD, cystic fibrosis, or other significant respiratory disorder including significant occupational or environmental exposures with ongoing respiratory symptoms. * No current or past smoking history * Have a post-bronchodilator FEV1/FVC ratio of \>70% Exclusion Criteria: Any potential subject who meets any of the following criteria will be excluded from participating in the study: * Patients with other non-COPD airway diseases * Patients with very severe COPD (FEV1\<30% predicted) * Patients with an intercurrent exacerbation * Patients with life expectancy less than 3 months * Pregnant or breastfeeding * Undergoing immunomodulatory or biologic treatment * Use of systemic steroids in the last month * Hospitalization in the last 12 months due to exacerbation * Known cardiovascular comorbidity under treatment or with hospitalizations of this cause in the last year * That they cannot perform spirometry * Active malignancy * Realization of lung surgery during the study period * History of alcohol and drug abuse that prevents compliance with follow-up * History of bronchial thermoplasty * Participating in another study concomitantly * MRI Related: patients who have implanted mechanically, electrically or magnetically activated device or any metal in their body which cannot be removed, including but not limited to pacemakers, artificial limb, metallic fragments of foreign body, shunt, surgical staples (including clips or metallic sutures and/or ear implants).
Where this trial is running
Hamilton, Ontario
- Firestone Institute for Respiratory Health, St. Joseph's Healthcare — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Sarah Svenningsen, PhD
- Email: svennins@mcmaster.ca
- Phone: 905-522-1155
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.