Phase 4
N=19
Hypoxic Pulmonary Vasoconstriction Pilot Study
Emphysema
Bottom Line
View on ClinicalTrials.gov: NCT03733470 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Perfused Blood Volume Assessed for a Change in Lung Inflammation Pre and Post Dose Sildenafil Administration — 0.37; 0.42 coefficient of variation — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sildenafil study group (Drug)
- Age
- Adult · 30+ yrs
- Sex
- All
- Sponsor
- Eric A. Hoffman
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Perfused Blood Volume Assessed for a Change in Lung Inflammation Pre and Post Dose Sildenafil Administration |
0.37; 0.42 | <0.05 sig |
Summary
The purpose of this study is to determine if the events leading to smoking-associated centrilobular and paraseptal emphysema are caused by a failure of the lungs' inherent mechanisms to block hypoxic pulmonary vasoconstriction (HPV) in areas of smoking-induced inflammation.
Eligibility Criteria
Inclusion Criteria
- Must be between the ages of 30 and 60.
- Must be currently smoking at least 1/2 pack/day (confirmed with cotinine level).
- Must have pulmonary function test (PFT) results that meet the following:
- Forced Expiratory Volume at one second (FEV1)/Forced Vital Capacity (FVC) > 70%
- Forced Expiratory Flow at 25-75% (FEF25-75) > 79% of predicted
- FVC greater than 80% of predicted
- Must be able to give informed consent for self.
Exclusion Criteria
- Pregnant or breastfeeding females.
- Body Mass Index (BMI) greater than 32.
- Weight of greater than 220 pounds (100 kg).
- Allergies to shell fish, seafood, eggs or iodine.
- Heart disease, kidney disease or diabetes.
- Diagnosis of asthma.
- Usage of any medications that are known to affect the heart or lungs (contraceptives, anti-depressants, analgesics EXCEPT aspirin, antihypertensives, and medications for osteoporosis and gastrointestinal diseases will be allowed).
- Any metal in or on the body between the nose and the abdomen.
- Any major organ system disease (by judgment of study medical team).
For the subjects that will receive Sildenafil as part of the study, additional exclusion criteria are as follows:
- Nitroglycerin usage.
- Prior history of hypersensitivity to Sildenafil.
Data sourced from ClinicalTrials.gov (NCT03733470). 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.