Characterizing Matrix Metalloproteinase-12 (MMP12) in Sputum

Launched by MCMASTER UNIVERSITY · Feb 17, 2021

Keywords

ClinConnect Summary

This clinical trial, titled "Characterizing Matrix Metalloproteinase-12 (MMP12) in Sputum," is investigating the role of a specific protein (MMP12) found in the sputum (mucus you cough up) of patients with emphysema. Researchers want to see if higher levels of this protein in sputum or blood are related to the worsening of lung condition and an increase in certain immune markers. The trial is currently looking for participants aged 40 and older who have been diagnosed with emphysema and have a history of smoking.

To qualify for the study, participants must have a specific measure of lung function that shows they have emphysema and must be either current or former smokers. Those who do not have any respiratory diseases and have never smoked may also be eligible as a comparison group. Participants in the trial will provide sputum and blood samples, and their lung function will be assessed. It's important to note that certain health conditions, recent treatments, or events may disqualify individuals from participating, so it's essential to review the eligibility criteria carefully.

Gender

ALL

Eligibility 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).