Status:
RECRUITING
Characterizing Matrix Metalloproteinase-12 (MMP12) in Sputum
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Foresee Pharmaceuticals Co., Ltd.
Conditions:
Emphysema
Eligibility:
All Genders
40-85 years
Brief 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.
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
November 29 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04761393
Start Date
November 29 2022
End Date
January 1 2025
Last Update
November 20 2024
Active Locations (1)
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1
Firestone Institute for Respiratory Health, St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 4A6