Imaging Regional Lung Defect Severity
COPD
Bottom Line
View on ClinicalTrials.gov: NCT01640288 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Perfluorinated Gas/Oxygen Mixture (Drug); High Resolution CT of the Chest (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hal C Charles
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gas Trapping Measured During Washout of the Perfluorinated Gas Mixture. |
0.718; 0.541; 0.308; 0.451 | <0.0001 sig |
| SECONDARY Ventilation Defect Severity During wash-in of the Perfluorinated Gas Mixture |
0.388; 0.504 | <0.0001 sig |
Summary
Eligibility Criteria
COPD Subjects: All subjects will be adults (age >18) with spirometrically confirmed COPD (GOLD stages I-IV) recruited from the greater Durham, North Carolina community. We anticipate 52% female and 14% minority based on community demographics and previous COPD study recruitment (see below). No subject will be excluded from the study on the basis of gender or ethnicity. Female subjects of childbearing potential will undergo pregnancy testing at study entry, and before each procedure. Informed consent will be obtained before a subject begins any study.
Definition of COPD: We will define COPD in accordance with the World Health Organization definition as a lung disease characterized by chronic obstruction of lung airflow that interferes with normal breathing and is not fully reversible. Furthermore, we will classify COPD severity using post bronchodilator GOLD spirometry criteria:
forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) 80% predicted Moderate (GOLD II): FEV1 50-80% predicted Severe (GOLD III): FEV1 30-50% predicted Very Severe (GOLD IV): FEV1 18.
- Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed.)
- Women of childbearing potential must have a negative serum pregnancy test. This will be confirmed before participation in this investigational protocol.
- Clinical diagnosis of COPD confirmed by spirometry demonstrating FEV1/FVC 18) with normal pulmonary function tests (spirometrically confirmed) recruited from the greater Durham, North Carolina community. We anticipate 52% female and 14% minority based on community demographics (see below). No subject will be excluded from the study on the basis of gender or ethnicity. Female subjects of childbearing potential will undergo pregnancy testing at study entry, and before each procedure. Informed consent will be obtained before a subject begins any study.
Inclusion criteria,
- Outpatients of either gender, age > 18.
- Willing and able to give informed consent and adhere to visit/protocol schedules. (Consent must be given before any study procedures are performed.)
- Women of childbearing potential must have a negative serum pregnancy test. This will be confirmed before participation in this investigational protocol.
- Normal pulmonary function testing (PFT) determined by spirometry.
Exclusion criteria
- Abuse of alcohol or illicit substances
- Conditions that will prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine)
Data sourced from ClinicalTrials.gov (NCT01640288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.