Health TrialsbyHealthPanel

Characterizing Matrix Metalloproteinase-12 (MMP12) in Sputum

ConditionEmphysema
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-85
SponsorMcMaster University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

≥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

Disqualifiers

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

Trial population

This is a cross-sectional study in healthy controls and patients with pulmonary emphysema.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Hyperpolarized 129Xe (Xenon) diffusion-weighted MRI

    Procedure/Surgery

    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

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Patients with emphysema and eosinophilia in blood and sputum1 intervention
Group B: Patients with emphysema and paucicellular inflammation1 intervention
Group C: Patients with emphysema and sputum neutrophilia1 intervention

Trial outcomes

Primary outcomes

1

Blood and sputum matrix metalloproteinase-12 (MMP12) levels

Measure sputum and blood MMP12 levels

Time frame
Baseline
2

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
3

Measure other T2 activity biomarkers in sputum

Sputum: enumeration of Free eosinophils granules (FEG) by none, few moderate and many

Time frame
Baseline
4

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

McMaster University

Lead sponsor

Foresee Pharmaceuticals Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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