RecruitingNCT04761393
Characterizing Matrix Metalloproteinase-12 (MMP12) in Sputum
Characterizing Mmp12 In Sputum And Its Relationship To Emphysema And Inflammatory Endotypes
Sponsor
McMaster University
Enrollment
45 participants
Start Date
Nov 29, 2022
Study Type
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Min Age: 40 YearsMax Age: 85 Years
Inclusion Criteria7
- ≥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
- 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 Criteria17
- 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).
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
PROCEDUREHyperpolarized 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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04761393
Related Trials
Analysing Peripheral Skeletal Muscle Function Before and After Endobronchial Valve Treatment
NCT060255001 location
STRIVE Post-Market Registry Study
NCT0430227214 locations
Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3
NCT0689175522 locations
A Trial of the Implantable Artificial Bronchus 50 Flex in Patients With Severe Emphysema
NCT070863392 locations
Implementation of a Sarcopenia Clinic to Diagnose and Treat Skeletal Muscle Loss Due to COPD
NCT070596371 location