EmphysemaPhase 4NCT03733470
Hypoxic Pulmonary Vasoconstriction Pilot Study
A Phase 4 study testing Sildenafil study group in people with Emphysema, run by Eric A. Hoffman at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Emphysema
- What is being tested?
- Sildenafil study group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2011to 13 Jan 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study for Perfusion Heterogeneity: a Mechanistic Image-Based Emphysema Phenotype
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.
Read the detailed description
Overall goals of this study are to 1) determine the effects on sildenafil on the heterogeneity perfused blood volume in smokers susceptible to emphysema using dual energy CT 2) utilize pulmonary blood volume heterogeneity as an image-based biomarker to differentiate normal and susceptible smokers.
- Conditions
- Emphysema
- Being tested
- Sildenafil study group
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sildenafil study groupDrug
Also called Revatio
One dose of 20 mg Sildenafil will be given one hour before CT imaging.
| Study group | Role | What they receive |
|---|---|---|
| Nonsusceptible Smokers (NS) | Experimental | 8 subjects recruited to study non-contrast imaging at TLC and 20%VC and with contrast using DECT to assess perfused blood volume. For the intervention, the subject will be administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration. Receives: Drug: Sildenafil study group |
| Susceptible Smokers (SS) | Experimental | 11 subjects recruited to study non-contrast imaging at TLC and 20% VC and with contrast using DECT to assess pefused blood volume. For the intervention the subject will be administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration. Receives: Drug: Sildenafil study group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfused Blood Volume Assessed for a Change in Lung Inflammation Pre and Post Dose Sildenafil Administration
Perfused blood volume will be measured by CT scan at two time points and compared at two points, pre and post the administration of sildenafil.
Measured: Change of perfused blood volume from baseline at one hour after sildenafil administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start29 Jun 2011
- Primary completion13 Jan 2014
- Study completion13 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eric A. Hoffman
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Eric A. Hoffman, University of Iowa
- Investigators
- Eric A Hoffman, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733470
- Sponsor's protocol ID
- 201101707
- Other IDs
- 5R01HL112986
- Status last verified
- Aug 2019
- First submitted
- 23 Oct 2018
- Last updated
- 1 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: CT images will be shared including non-contrast images at Total Lung Capacity (TLC), Functional Residual Capacity (FRC) and Residual Volume (RV) as well as dual energy CT image data used to assess regional perfused blood volume. All associated pulmonary function test results will be shared. CT-derived metrics
Publications
Alford SK, van Beek EJ, McLennan G, Hoffman EA. Heterogeneity of pulmonary perfusion as a mechanistic image-based phenotype in emphysema susceptible smokers. Proc Natl Acad Sci U S A. 2010 Apr 20;107(16):7485-90. doi: 10.1073/pnas.0913880107. Epub 2010 Apr 5.
PubMed 20368443
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study for Perfusion Heterogeneity: a Mechanistic Image-Based Emphysema Phenotype
- ClinicalTrials.gov ID
- NCT03733470
- Acronym / sponsor ID
- 201101707
- Conditions
- Emphysema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Eric A. HoffmanUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 29 Jun 2011 (actual)
- Primary completion
- 13 Jan 2014 (actual)
- Study completion
- 13 Jan 2014 (actual)
- First posted
- 7 Nov 2018 (actual)
- Results
- Posted 1 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Overall goals of this study are to 1) determine the effects on sildenafil on the heterogeneity perfused blood volume in smokers susceptible to emphysema using dual energy CT 2) utilize pulmonary blood volume heterogeneity as an image-based biomarker to differentiate normal and susceptible smokers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nonsusceptible Smokers (NS) | Experimental | Drug: Sildenafil study group8 subjects recruited to study non-contrast imaging at TLC and 20%VC and with contrast using DECT to assess perfused blood volume. For the intervention, the subject will be administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration. |
| Susceptible Smokers (SS) | Experimental | Drug: Sildenafil study group11 subjects recruited to study non-contrast imaging at TLC and 20% VC and with contrast using DECT to assess pefused blood volume. For the intervention the subject will be administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sildenafil study groupAlso: RevatioOne dose of 20 mg Sildenafil will be given one hour before CT imaging. | Drug | Nonsusceptible Smokers (NS), Susceptible Smokers (SS) |
Primary outcome
Perfused Blood Volume Assessed for a Change in Lung Inflammation Pre and Post Dose Sildenafil Administration
Time frame: Change of perfused blood volume from baseline at one hour after sildenafil administration.
Perfused blood volume will be measured by CT scan at two time points and compared at two points, pre and post the administration of sildenafil.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20368443Alford SK, van Beek EJ, McLennan G, Hoffman EA. Heterogeneity of pulmonary perfusion as a mechanistic image-based phenotype in emphysema susceptible smokers. Proc Natl Acad Sci U S A. 2010 Apr 20;107(16):7485-90. doi: 10.1073/pnas.0913880107. Epub 2010 Apr 5.
- Individual participant dataSharing planned: Yes. CT images will be shared including non-contrast images at Total Lung Capacity (TLC), Functional Residual Capacity (FRC) and Residual Volume (RV) as well as dual energy CT image data used to assess regional perfused blood volume. All associated pulmonary function test results will be shared. CT-derived metrics
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric A Hoffman principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sildenafil study group in people with Emphysema, run by Eric A. Hoffman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perfused Blood Volume Assessed for a Change in Lung Inflammation Pre and Post Dose Sildenafil Administration (time frame: Change of perfused blood volume from baseline at one hour after sildenafil administration.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03733470, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.