Chronic Obstructive Pulmonary DiseasePhase 2NCT01941225
Inhaled Iloprost, Dynamic Hyperinflation, and Oxidative Stress in COPD Patients
A Phase 2 study testing Inhaled iloprost 5.0 mcg in people with Chronic Obstructive Pulmonary Disease, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial summary
The purpose of this study is to investigate the role of the pulmonary vasculature in the development and progression of chronic obstructive pulmonary disease (COPD). To accomplish this, an inhaled prostacyclin (iloprost) will be given to patients with COPD and changes in oxidative stress and lung volumes during… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Inhaled iloprost 5.0 mcg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Nov 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40 years old or older
- Physician diagnosis of chronic obstructive pulmonary disease
- 10 or more pack-year smoking history
- FEV1/FVC <0.70
- FEV1 35-80% of predicted
Who cannot join
- Acute exacerbation of COPD within the last 30 days
- Pregnant or breast-feeding
- Contraindications to cardiopulmonary exercise testing
- Known intolerance or allergy to iloprost
- On oral corticosteroids (may be included if off for 7 days prior to testing)
- Supplemental oxygen need
- Known inflammatory disease other than COPD
- Active solid organ/hematologic malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
LSU Health Sciences Center
New Orleans, Louisiana, 70125
About this study
The purpose of this study is to investigate the role of the pulmonary vasculature in the development and progression of chronic obstructive pulmonary disease (COPD). To accomplish this, an inhaled prostacyclin (iloprost) will be given to patients with COPD and changes in oxidative stress and lung volumes during exercise will be measured.
Read the detailed description
Chronic obstructive pulmonary disease (COPD), the 3rd leading cause of death in the US, is a progressive disorder for which new treatments are urgently needed, as existing therapies are focused primarily on symptom relief. Oxidative stress, in part arising from inducible nitric oxide synthase (iNOS) released by the pulmonary vasculature, is critical for the development and progression of COPD; a treatment strategy focused on the pulmonary vasculature is hypothesized to be beneficial in COPD patients. This will be studied with the use of an inhaled prostacyclin analogue, iloprost, which has been approved for pulmonary hypertension and investigated in small studies of COPD patients. Potential mechanisms include reductions in dynamic hyperinflation during exercise in COPD patients or improvements in oxidative stress
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Inhaled iloprost 5.0 mcg, Placebo
- Keywords
- Chronic obstructive pulmonary disease, Pulmonary vasculature, Inhaled iloprost, Inhaled prostacyclin, Dynamic hyperinflation, Oxidative stress, Cardiopulmonary exercise testing, B-type natriuretic peptide
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled iloprost 5.0 mcgDrug
Also called Ventavis
Single administration
PlaceboDrug
Also called Nebulized normal saline
Single administration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Nebulized normal saline. Single administration Receives: Drug: Placebo |
| Inhaled iloprost 5.0 mcg | Experimental | Single administration Receives: Drug: Inhaled iloprost 5.0 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic hyperinflation during maximal cardiopulmonary exercise test
Dynamic hyperinflation will be measured as EELV/TLC ratio (end-expiratory lung volume/total lung capacity ratio) during exercise
Measured: Acute response (exercise testing performed 30 minutes after study drug administration)
Secondary outcomes (10)
Blood markers of oxidative stress
8-isoprostane, superoxide dismutase, catalase, nitrite, malondialdehyde
Measured: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
Blood markers of inflammation
IL-1 beta, IL-6, IL-8, IL-10, IL-13, IL-18, TNF-alpha
Measured: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
Dead space fraction
Measured: Acute response (measured every 2 minutes during exercise, starting 30 minutes after study drug administration)
B-type natriuretic peptide
Measured: Acute response (measured 30 and 40 minutes after study drug administration)
Partial pressure of oxygen
Measured: Acute response (measured 30 minutes after study drug administration and every 2 minutes during exercise)
Metabolic and gas exchange parameters during cardiopulmonary exercise test
Measured: Acute response (throughout exercise, starting 30 minutes after study drug administration)
Blood cyclic AMP levels
Measured: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
Blood iloprost levels
Measured: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
Exercise time and external work performed
Measured: measured during exercise test 30 minutes after study drug administration
Borg dyspnea and leg scores
Measured: During exericse (starting 30 minutes after study drug administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Lammi, Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Matthew R Lammi, MD, Principal investigator, LSU Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01941225
- Sponsor's protocol ID
- GM104940-50346-S
- Status last verified
- Dec 2016
- First submitted
- 9 Sep 2013
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Iloprost, Dynamic Hyperinflation, and Oxidative Stress in COPD Patients
- ClinicalTrials.gov ID
- NCT01941225
- Acronym / sponsor ID
- GM104940-50346-S
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, Pulmonary vasculature, Inhaled iloprost, Inhaled prostacyclin, Dynamic hyperinflation, Oxidative stress, Cardiopulmonary exercise testing, B-type natriuretic peptide
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 13 Sep 2013 (estimated)
- Results
- Not posted in the source record
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 investigate the role of the pulmonary vasculature in the development and progression of chronic obstructive pulmonary disease (COPD). To accomplish this, an inhaled prostacyclin (iloprost) will be given to patients with COPD and changes in oxidative stress and lung volumes during exercise will be measured.
Detailed description
Chronic obstructive pulmonary disease (COPD), the 3rd leading cause of death in the US, is a progressive disorder for which new treatments are urgently needed, as existing therapies are focused primarily on symptom relief. Oxidative stress, in part arising from inducible nitric oxide synthase (iNOS) released by the pulmonary vasculature, is critical for the development and progression of COPD; a treatment strategy focused on the pulmonary vasculature is hypothesized to be beneficial in COPD patients. This will be studied with the use of an inhaled prostacyclin analogue, iloprost, which has been approved for pulmonary hypertension and investigated in small studies of COPD patients. Potential mechanisms include reductions in dynamic hyperinflation during exercise in COPD patients or improvements in oxidative stress
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboNebulized normal saline. Single administration |
| Inhaled iloprost 5.0 mcg | Experimental | Drug: Inhaled iloprost 5.0 mcgSingle administration |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 40 years old or older
- Physician diagnosis of chronic obstructive pulmonary disease
- 10 or more pack-year smoking history
- FEV1/FVC <0.70
- FEV1 35-80% of predicted
Key exclusion criteria (8 listed)
- Acute exacerbation of COPD within the last 30 days
- Pregnant or breast-feeding
- Contraindications to cardiopulmonary exercise testing
- Known intolerance or allergy to iloprost
- On oral corticosteroids (may be included if off for 7 days prior to testing)
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 |
|---|---|---|
| Inhaled iloprost 5.0 mcgAlso: VentavisSingle administration | Drug | Inhaled iloprost 5.0 mcg |
| PlaceboAlso: Nebulized normal salineSingle administration | Drug | Placebo |
Primary outcome
Dynamic hyperinflation during maximal cardiopulmonary exercise test
Time frame: Acute response (exercise testing performed 30 minutes after study drug administration)
Dynamic hyperinflation will be measured as EELV/TLC ratio (end-expiratory lung volume/total lung capacity ratio) during exercise
10 secondary outcomes
Blood markers of oxidative stress
Time frame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
Blood markers of inflammation
Time frame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
Dead space fraction
Time frame: Acute response (measured every 2 minutes during exercise, starting 30 minutes after study drug administration)
B-type natriuretic peptide
Time frame: Acute response (measured 30 and 40 minutes after study drug administration)
Partial pressure of oxygen
Time frame: Acute response (measured 30 minutes after study drug administration and every 2 minutes during exercise)
Metabolic and gas exchange parameters during cardiopulmonary exercise test
Time frame: Acute response (throughout exercise, starting 30 minutes after study drug administration)
Blood cyclic AMP levels
Time frame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
Blood iloprost levels
Time frame: Acute response (measured 10 minutes, 30 minutes, 40 minutes, and 100 minutes after study drug administration)
Exercise time and external work performed
Time frame: measured during exercise test 30 minutes after study drug administration
Borg dyspnea and leg scores
Time frame: During exericse (starting 30 minutes after study drug administration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2016.
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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.
Matthew R Lammi, MD principal investigator
LSU Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inhaled iloprost 5.0 mcg in people with Chronic Obstructive Pulmonary Disease, run by Louisiana State University Health Sciences Center in New Orleans 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 5 inclusion and 8 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 16 Dec 2016. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dynamic hyperinflation during maximal cardiopulmonary exercise test (time frame: Acute response (exercise testing performed 30 minutes after study drug administration)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2016.