Respiratory Distress Syndrome, AdultPhase 2NCT00351533
A Phase II Randomized Trial of Fish Oil in Patients With Acute Lung Injury (ALI)
A Phase 2 study testing Fish oil (eicosapentaenoic acid and docosahexanoic acid) in people with Respiratory Distress Syndrome, Adult and Acute Lung Injury, run by University of Washington at 5 sites in 2 countries.
Trial summary
The purpose of this study is to determine whether fish oil (containing omega-3 fatty acids) given enterally is safe and effective in reducing lung and systemic inflammation seen in acute lung injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult, Acute Lung Injury, Acute Respiratory Distress Syndrome
- What is being tested?
- Fish oil (eicosapentaenoic acid and docosahexanoic acid)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jul 2006to Aug 2009
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Requiring positive-pressure mechanical ventilation
- ALI criteria: PaO2/FiO2 <300, bilateral infiltrates on chest radiograph, no left atrial hypertension
- Age > 17 years
Who cannot join
- Expected ICU length of stay <48 hours
- Unable to undergo bronchoalveolar lavage at enrollment
- Unable to obtain enteral access
- Post-cardiac arrest with suspected significant anoxic brain injury
- Expected survival < 28 days
- Pregnant
Show all 12Show fewer
- Platelet count < 30,000, active bleeding, or international normalized ratio (INR)>3.0
- History of ventricular tachycardia or fibrillation
- Receiving recombinant human activated protein C (rh-APC) for sepsis
- Acquired immune deficiency syndrome (AIDS) with CD4 count < 200
- Metastatic cancer
- History of bone marrow, lung, liver, cardiac, kidney, or pancreas transplant
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
St. Alphonsus Medical Center
Boise, Idaho, 83706
University of Vermont/Fletcher Allen Health Care
Burlington, Vermont, 05401
Oregon Health Sciences University
Portland, Oregon, 97239
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: A Randomized, Double-blind Study of the Effect of Fish Oil (Eicosapentaenoic Acid and Docosahexanoic Acid) on Lung and Systemic Inflammation in Patients With Acute Lung Injury (ALI)
The purpose of this study is to determine whether fish oil (containing omega-3 fatty acids) given enterally is safe and effective in reducing lung and systemic inflammation seen in acute lung injury.
Read the detailed description
Acute lung injury (ALI) is common among critically ill patients and is associated with a high case fatality. Only one intervention has been shown to improve survival in a large clinical trial, and new therapies targeting the inflammatory response are needed. Nutrient interventions may provide benefit; specifically there is plausible biologic rationale for administering n-3 fatty acids (n-3 FAs) found in fish oil to patients with ALI, as n-3 FAs decrease formation of eicosanoid inflammatory mediators. However, although promising results have emerged from prior studies, fish oils have only been tested in ALI patients in a commercial enteral formula containing additional nutrients, and the control group received a high-fat enteral formula that may have been proinflammatory. Therefore, no conclusion can be drawn about the independent effect of fish oils. Furthermore, the inclusion of key pharmaconutrients in feeding formulas, instead of delivering them separately as pharmaceuticals, limits exposure to the agent, as intensive care unit (ICU) patients commonly receive less than 60% of prescribed caloric needs. Finally, specialized feeding formulas are very expensive, and it may be substantially cheaper to administer pharmaconutrients separately. We believe it is time to begin to approach nutrient trials in critically ill patients differently -- to move away from including them in feeding formulas and begin delivering them like pharmaceuticals. With appropriate scientific investigation and the use of non-nutrient placebos, this novel and innovative approach is a new paradigm of investigating nutrient delivery to critically ill patients.
This study is a phase II randomized controlled trial to determine the effects of enteral eicosapentaenoic acid (EPA) and docosahexanoic acid (DHA), both n-3 FAs found in fish oil, versus placebo on the pulmonary and systemic environments, and on clinical outcomes, in patients with ALI. We will investigate the effect of fish oil administration on several biological markers of injury and inflammation in bronchoalveolar lavage fluid and serum, on pulmonary physiologic outcomes, and on clinical outcomes.
Comparison(s): Mechanically ventilated patients with acute lung injury randomized to receive enteral fish oil versus compared to mechanically ventilated patients with acute lung injury randomized to receive placebo.
- Conditions
- Respiratory Distress Syndrome, Adult, Acute Lung Injury, Acute Respiratory Distress Syndrome
- Being tested
- Fish oil (eicosapentaenoic acid and docosahexanoic acid)
- Keywords
- Respiratory distress syndrome, adult, Acute lung injury, Acute respiratory distress syndrome, ARDS, human, Fish oils, Fatty Acids, Omega-3, Docosahexaenoic Acids, Eicosapentaenoic Acid
- Medical subject headings
- Respiratory Distress Syndrome, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fish oil (eicosapentaenoic acid and docosahexanoic acid)Drug
Liquid fish oil 7.5cc enterally every 6 hours
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Enteral fish oil Receives: Drug: Fish oil (eicosapentaenoic acid and docosahexanoic acid) |
| 2 | Placebo comparator | Enteral saline Receives: Drug: Fish oil (eicosapentaenoic acid and docosahexanoic acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8
30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Measured: Days 1 and 5
Secondary outcomes (27)
Change in BALF Leukotriene B4
30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Measured: Days 1 and 5
Change in BALF Interleukin-6
30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Measured: Days 1 and 5
Change in BALF Monocyte Chemotactic Protein-1
30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Measured: Days 1 and 5
Change in BALF Neutrophil Count
30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Measured: Days 1 and 5
Static Lung Compliance
30 patients in the fish oil group and 36 patients in the enteral saline group remained intubated on day 5 and had this outcome available.
Measured: Day 5
Oxygenation
PaO2/FiO2 is the ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen. 30 patients in the fish oil group and 36 patients in the enteral saline group remained intubated on day 5 and had this outcome available.
Measured: Day 5
Change in Plasma Interleukin-8
30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
Measured: Days 1 and 5
Change in Plasma Leukotriene B4
30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
Measured: Days 1 and 5
Change in Plasma Interleukin-6
30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
Measured: Days 1 and 5
Change in Plasma Surfactant Protein D
30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
Measured: Days 1 and 5
Change in Plasma vonWillebrand Factor
30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
Measured: Days 1 and 5
Worst Multiple Organ Dysfunction Score (MODS) During First 28 Days After Study Enrollment
Full scale name is Multiple Organ Dysfunction Score (MODS), a scale measuring degree of organ dysfunction in critically ill patients.
Minimum score is 0 and maximum score is 24, with 0 indicating no organ failure and 24 indicating severe failure of multiple organs.
Measured: Throughout hospital stay
Ventilator-free Days During First 28 Days After Study Enrollment
Ventilator-free days is a common outcome measure in critical care research. A ventilator-free day is a day that a participant is alive and not receiving mechanical ventilation during the first 28 days after s/he enrolled in the study.
Measured: 28 days
ICU-free Days During First 28 Days After Study Enrollment
ICU-free days is a common outcome measure in critical care research. An ICU-free day is a day that a participant is alive and not in the intensive care unit (ICU) during the first 28 days after s/he enrolled in the study.
Measured: 28 days
Hospital Length of Stay
Measured: At end of hospital admission
Hospital Mortality
Measured: At end of hospitalization
60-day Mortality
Measured: 60 days from day of enrollment into study
Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8
15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Measured: Days 1 and 9
Change in BALF Leukotriene B4
15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Measured: Days 1 and 9
Change in BALF Interleukin-6
15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Measured: Days 1 and 9
Change in BALF Monocyte Chemotactic Protein-1
15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Measured: Days 1 and 9
Change in BALF Neutrophil Count
15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
Measured: Days 1 and 9
Change in Plasma Interleukin-8
15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
Measured: Days 1 and 9
Change in Plasma Leukotriene B4
15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
Measured: Days 1 and 9
Change in Plasma Interleukin-6
15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
Measured: Days 1 and 9
Change in Plasma Surfactant Protein D
15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
Measured: Days 1 and 9
Change in Plasma vonWillebrand Factor
15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.
Measured: Days 1 and 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionJan 2009
- Study completionAug 2009
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.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), American Thoracic Society, Acute Respiratory Distress Syndrome Foundation, American Society for Parenteral and Enteral Nutrition
- Responsible party
- Principal investigator, Renee Stapleton, University of Washington
- Investigators
- Renee D. Stapleton, MD, MSc, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00351533
- Sponsor's protocol ID
- 28503-A
- Other IDs
- 05-7895-A 03
- Status last verified
- Aug 2011
- First submitted
- 11 Jul 2006
- Last updated
- 3 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Study of the Effect of Fish Oil (Eicosapentaenoic Acid and Docosahexanoic Acid) on Lung and Systemic Inflammation in Patients With Acute Lung Injury (ALI)
- ClinicalTrials.gov ID
- NCT00351533
- Acronym / sponsor ID
- 28503-A
- Conditions
- Respiratory Distress Syndrome, Adult, Acute Lung Injury, Acute Respiratory Distress Syndrome
- Keywords
- Respiratory distress syndrome, adult, Acute lung injury, Acute respiratory distress syndrome, ARDS, human, Fish oils, Fatty Acids, Omega-3, Docosahexaenoic Acids, Eicosapentaenoic Acid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), American Thoracic Society, Acute Respiratory Distress Syndrome Foundation, American Society for Parenteral and Enteral Nutrition
- Study start
- Jul 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 13 Jul 2006 (estimated)
- Results
- Posted 3 Oct 2011
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 whether fish oil (containing omega-3 fatty acids) given enterally is safe and effective in reducing lung and systemic inflammation seen in acute lung injury.
Detailed description
Acute lung injury (ALI) is common among critically ill patients and is associated with a high case fatality. Only one intervention has been shown to improve survival in a large clinical trial, and new therapies targeting the inflammatory response are needed. Nutrient interventions may provide benefit; specifically there is plausible biologic rationale for administering n-3 fatty acids (n-3 FAs) found in fish oil to patients with ALI, as n-3 FAs decrease formation of eicosanoid inflammatory mediators. However, although promising results have emerged from prior studies, fish oils have only been tested in ALI patients in a commercial enteral formula containing additional nutrients, and the control group received a high-fat enteral formula that may have been proinflammatory. Therefore, no conclusion can be drawn about the independent effect of fish oils. Furthermore, the inclusion of key pharmaconutrients in feeding formulas, instead of delivering them separately as pharmaceuticals, limits exposure to the agent, as intensive care unit (ICU) patients commonly receive less than 60% of prescribed caloric needs. Finally, specialized feeding formulas are very expensive, and it may be substantially cheaper to administer pharmaconutrients separately. We believe it is time to begin to approach nutrient trials in critically ill patients differently -- to move away from including them in feeding formulas and begin delivering them like pharmaceuticals. With appropriate scientific investigation and the use of non-nutrient placebos, this novel and innovative approach is a new paradigm of investigating nutrient delivery to critically ill patients.
This study is a phase II randomized controlled trial to determine the effects of enteral eicosapentaenoic acid (EPA) and docosahexanoic acid (DHA), both n-3 FAs found in fish oil, versus placebo on the pulmonary and systemic environments, and on clinical outcomes, in patients with ALI. We will investigate the effect of fish oil administration on several biological markers of injury and inflammation in bronchoalveolar lavage fluid and serum, on pulmonary physiologic outcomes, and on clinical outcomes.
Comparison(s): Mechanically ventilated patients with acute lung injury randomized to receive enteral fish oil versus compared to mechanically ventilated patients with acute lung injury randomized to receive placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fish oil (eicosapentaenoic acid and docosahexanoic acid)Enteral fish oil |
| 2 | Placebo comparator | Drug: Fish oil (eicosapentaenoic acid and docosahexanoic acid)Enteral saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Requiring positive-pressure mechanical ventilation
- ALI criteria: PaO2/FiO2 <300, bilateral infiltrates on chest radiograph, no left atrial hypertension
- Age > 17 years
Key exclusion criteria (12 listed)
- Expected ICU length of stay <48 hours
- Unable to undergo bronchoalveolar lavage at enrollment
- Unable to obtain enteral access
- Post-cardiac arrest with suspected significant anoxic brain injury
- Expected survival < 28 days
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 |
|---|---|---|
| Fish oil (eicosapentaenoic acid and docosahexanoic acid)Liquid fish oil 7.5cc enterally every 6 hours | Drug | 1, 2 |
Primary outcome
Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8
Time frame: Days 1 and 5
30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.
27 secondary outcomes
Change in BALF Leukotriene B4
Time frame: Days 1 and 5
Change in BALF Interleukin-6
Time frame: Days 1 and 5
Change in BALF Monocyte Chemotactic Protein-1
Time frame: Days 1 and 5
Change in BALF Neutrophil Count
Time frame: Days 1 and 5
Static Lung Compliance
Time frame: Day 5
Oxygenation
Time frame: Day 5
Change in Plasma Interleukin-8
Time frame: Days 1 and 5
Change in Plasma Leukotriene B4
Time frame: Days 1 and 5
Change in Plasma Interleukin-6
Time frame: Days 1 and 5
Change in Plasma Surfactant Protein D
Time frame: Days 1 and 5
Change in Plasma vonWillebrand Factor
Time frame: Days 1 and 5
Worst Multiple Organ Dysfunction Score (MODS) During First 28 Days After Study Enrollment
Time frame: Throughout hospital stay
Ventilator-free Days During First 28 Days After Study Enrollment
Time frame: 28 days
ICU-free Days During First 28 Days After Study Enrollment
Time frame: 28 days
Hospital Length of Stay
Time frame: At end of hospital admission
Hospital Mortality
Time frame: At end of hospitalization
60-day Mortality
Time frame: 60 days from day of enrollment into study
Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8
Time frame: Days 1 and 9
Change in BALF Leukotriene B4
Time frame: Days 1 and 9
Change in BALF Interleukin-6
Time frame: Days 1 and 9
Change in BALF Monocyte Chemotactic Protein-1
Time frame: Days 1 and 9
Change in BALF Neutrophil Count
Time frame: Days 1 and 9
Change in Plasma Interleukin-8
Time frame: Days 1 and 9
Change in Plasma Leukotriene B4
Time frame: Days 1 and 9
Change in Plasma Interleukin-6
Time frame: Days 1 and 9
Change in Plasma Surfactant Protein D
Time frame: Days 1 and 9
Change in Plasma vonWillebrand Factor
Time frame: Days 1 and 9
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Renee D. Stapleton, MD, MSc principal investigator
University of Vermont
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fish oil (eicosapentaenoic acid and docosahexanoic acid) in people with Respiratory Distress Syndrome, Adult and Acute Lung Injury, run by University of Washington at 5 sites in 2 countries.
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 3 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 3 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 3 Oct 2011). 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?
Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8 (time frame: Days 1 and 5). 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 3 Oct 2011.