Acute Respiratory Distress Syndrome (ARDS)Phase 2LIPS-BNCT01783821
LIPS-B: Lung Injury Prevention Study With Budesonide and Beta
A Phase 2 study testing Budesonide and Formoterol in people with Acute Respiratory Distress Syndrome (ARDS), run by Mayo Clinic at 5 sites in United States.
Trial summary
This study tested whether inhaled budesonide and formoterol were able to alleviate or prevent pulmonary injury when administered early in hospital course to the patients at risk for developing acute respiratory distress syndrome (ARDS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- Budesonide and Formoterol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2013to Dec 2015
- 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
- Adult patients (age > 18)
- Admitted to the hospital through the emergency department (ED)
- High risk of developing ARDS (Lung Injury Prediction Score (LIPS) greater than or equal to four)
Who cannot join
- Inhaled corticosteroid and/or beta agonist treatment on admission or within 7 days prior to admission (history of asthma or COPD necessitating therapy)
- Chronic pulmonary disease requiring daytime oxygen supplementation therapy
- Systemic steroid treatment on admission or within 7 days prior to admission equivalent to more than 5 mg of prednisone daily
- Inability to obtain consent within 12 hours of hospital presentation
- Acute lung injury prior to randomization
- Receiving mechanical ventilation before current hospital admission (patient who is ventilator dependent)
Show all 18Show fewer
- Presentation believed to be purely due to heart failure without other known risk factors for ARDS
- Allergy or other contraindication to either budesonide and/or formoterol use
- Expected hospital stay and/or survival <48 hours or admission for comfort or hospice care
- Patient, surrogate or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
- Previous enrollment in this trial.
- Co-enrollment with LIPS-A trial is not allowed.
- An active enrollment in other concomitant trial will be judged on case by case basis by PIs of both trials.
- EKG and/or clinical presentation suggestive of acute coronary ischemia
- New onset cardiac arrhythmia
- Current atrial fibrillation with ventricular rate of >110/minute
- Persistent sinus tachycardia of >130/minute despite early goal directed therapy with fluids, pressors, antibiotics and supplemental oxygen
- Pregnant patients
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Beth Israel Medical Center
Boston, Massachusetts, 02215
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Stanford University
Stanford, California, 94305
University of Arizona
Tucson, Arizona, 85721
About this study
Official title: LIPS-B: Lung Injury Prevention Study With Budesonide and Beta Agonist (Formoterol)
This study tested whether inhaled budesonide and formoterol were able to alleviate or prevent pulmonary injury when administered early in hospital course to the patients at risk for developing acute respiratory distress syndrome (ARDS). The FDA has approved many uses for budesonide and formoterol, including asthma and chronic obstructive pulmonary disease (COPD), but the use of these two drugs is experimental for ARDS.
Read the detailed description
Subjects were randomized to either placebo or combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 calendar days for a total of 10 doses or until hospital discharge or death. Local hospital pharmacies prepared identical appearing solutions and drug was delivered by respiratory therapists blinded to randomization by using standard jet nebulizers that produce aerosol particle size within the respirable range (<5.5 microns). The first dose was administered within 4 hours after randomization.
- Being tested
- Budesonide, Placebo, Formoterol
- Keywords
- Acute respiratory distress syndrome (ARDS)
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
Also called Pulmicort
Subjects will receive the standard aerosolized dose of budesonide (0.5 mg).
PlaceboDrug
Aerosolized normal saline will be prepared to mimic the intervention arm, with the quantity, appearance and timing of the doses the being the same.
FormoterolDrug
Also called Foradil Aerolizer
Subjects will receive the standard aerosolized dose of formoterol (20 mcg) .
| Study group | Role | What they receive |
|---|---|---|
| Budesonide and Formoterol | Experimental | Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours. Receives: Drug: Budesonide; Drug: Formoterol |
| Placebo | Placebo comparator | Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio
Oxygen saturation (SpO2) was measured by pulse oximetry. FiO2 is the assumed proportion of oxygen concentration participating in gas exchange in the alveoli. All S/F measurements were performed per standard operating protocol using a Venturi mask titrated to obtain an oxygen saturation of 94 ± 2% unless the patient met this goal on room air or clinical status dictated an alternative delivery mode. This outcome measure was analyzed as a longitudinal continuous variable by a mixed effect model. The formula for the calculation of SpO2/FiO2 (or S/F ratio) is %saturation/proportion of FiO2 concentration.
Measured: baseline to day 5 after the first treatment
Number of Participants Experiencing Categorical Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio
The data in the table below represent the greatest change from baseline observed for any one participant over all individual post-baseline measurements.
Measured: Days 0 - 5
Secondary outcomes (4)
Number of Subjects Who Needed Mechanical Ventilation
Measured: Hospital discharge, approximately day 28
Number of Subjects Who Developed Acute Respiratory Distress Syndrome (ARDS)
ARDS was defined per Berlin definition. Chest radiographs of all ventilated (non-invasive or invasive) patients were reviewed as consistent or not consistent with ARDS by the site investigator. A second adjudication was performed by an alternate principal investigator blinded to subject identification and clinical data. Final diagnosis of ARDS was determined centrally after chest radiograph adjudication was considered together with other relevant clinical data.
Measured: Hospital discharge, approximately day 28
Hospital Length of Stay
Measured: Baseline to Day 28
Intensive Care Unit (ICU) Length of Stay
Measured: Baseline to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2015
- Study completionDec 2015
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 Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, Beth Israel Deaconess Medical Center, University of Arizona, National Center for Research Resources (NCRR)
- Responsible party
- Principal investigator, Emir Festic, Mayo Clinic
- Investigators
- Emir Festic, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783821
- Sponsor's protocol ID
- 12-008192
- Other IDs
- UL1RR024150
- Acronym
- LIPS-B
- Status last verified
- Jul 2016
- First submitted
- 31 Jan 2013
- Last updated
- 5 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Festic E, Carr GE, Cartin-Ceba R, Hinds RF, Banner-Goodspeed V, Bansal V, Asuni AT, Talmor D, Rajagopalan G, Frank RD, Gajic O, Matthay MA, Levitt JE. Randomized Clinical Trial of a Combination of an Inhaled Corticosteroid and Beta Agonist in Patients at Risk of Developing the Acute Respiratory Distress Syndrome. Crit Care Med. 2017 May;45(5):798-805. doi: 10.1097/CCM.0000000000002284.
PubMed 28240689
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIPS-B: Lung Injury Prevention Study With Budesonide and Beta Agonist (Formoterol)
- ClinicalTrials.gov ID
- NCT01783821
- Acronym / sponsor ID
- LIPS-B / 12-008192
- Keywords
- Acute respiratory distress syndrome (ARDS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Stanford University, Beth Israel Deaconess Medical Center, University of Arizona, National Center for Research Resources (NCRR)
- Study start
- Jul 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 5 Feb 2013 (estimated)
- Results
- Posted 5 Sep 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tested whether inhaled budesonide and formoterol were able to alleviate or prevent pulmonary injury when administered early in hospital course to the patients at risk for developing acute respiratory distress syndrome (ARDS). The FDA has approved many uses for budesonide and formoterol, including asthma and chronic obstructive pulmonary disease (COPD), but the use of these two drugs is experimental for ARDS.
Detailed description
Subjects were randomized to either placebo or combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 calendar days for a total of 10 doses or until hospital discharge or death. Local hospital pharmacies prepared identical appearing solutions and drug was delivered by respiratory therapists blinded to randomization by using standard jet nebulizers that produce aerosol particle size within the respirable range (<5.5 microns). The first dose was administered within 4 hours after randomization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budesonide and Formoterol | Experimental | Drug: Budesonide, Drug: FormoterolSubjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours. |
| Placebo | Placebo comparator | Drug: PlaceboSubjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (age > 18)
- Admitted to the hospital through the emergency department (ED)
- High risk of developing ARDS (Lung Injury Prediction Score (LIPS) greater than or equal to four)
Key exclusion criteria (18 listed)
- Inhaled corticosteroid and/or beta agonist treatment on admission or within 7 days prior to admission (history of asthma or COPD necessitating therapy)
- Chronic pulmonary disease requiring daytime oxygen supplementation therapy
- Systemic steroid treatment on admission or within 7 days prior to admission equivalent to more than 5 mg of prednisone daily
- Inability to obtain consent within 12 hours of hospital presentation
- Acute lung injury prior to randomization
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 |
|---|---|---|
| BudesonideAlso: PulmicortSubjects will receive the standard aerosolized dose of budesonide (0.5 mg). | Drug | Budesonide and Formoterol |
| PlaceboAerosolized normal saline will be prepared to mimic the intervention arm, with the quantity, appearance and timing of the doses the being the same. | Drug | Placebo |
| FormoterolAlso: Foradil AerolizerSubjects will receive the standard aerosolized dose of formoterol (20 mcg) . | Drug | Budesonide and Formoterol |
Primary outcome
Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio
Time frame: baseline to day 5 after the first treatment
Oxygen saturation (SpO2) was measured by pulse oximetry. FiO2 is the assumed proportion of oxygen concentration participating in gas exchange in the alveoli. All S/F measurements were performed per standard operating protocol using a Venturi mask titrated to obtain an oxygen saturation of 94 ± 2% unless the patient met this goal on room air or clinical status dictated an alternative delivery mode. This outcome measure was analyzed as a longitudinal continuous variable by a mixed effect model. The formula for the calculation of SpO2/FiO2 (or S/F ratio) is %saturation/proportion of FiO2 concentration.
Number of Participants Experiencing Categorical Change in Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio
Time frame: Days 0 - 5
The data in the table below represent the greatest change from baseline observed for any one participant over all individual post-baseline measurements.
4 secondary outcomes
Number of Subjects Who Needed Mechanical Ventilation
Time frame: Hospital discharge, approximately day 28
Number of Subjects Who Developed Acute Respiratory Distress Syndrome (ARDS)
Time frame: Hospital discharge, approximately day 28
Hospital Length of Stay
Time frame: Baseline to Day 28
Intensive Care Unit (ICU) Length of Stay
Time frame: Baseline to Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28240689Festic E, Carr GE, Cartin-Ceba R, Hinds RF, Banner-Goodspeed V, Bansal V, Asuni AT, Talmor D, Rajagopalan G, Frank RD, Gajic O, Matthay MA, Levitt JE. Randomized Clinical Trial of a Combination of an Inhaled Corticosteroid and Beta Agonist in Patients at Risk of Developing the Acute Respiratory Distress Syndrome. Crit Care Med. 2017 May;45(5):798-805. doi: 10.1097/CCM.0000000000002284.
- Individual participant dataSharing planned: No
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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.
Emir Festic, MD principal investigator
Mayo Clinic
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Budesonide and Formoterol in people with Acute Respiratory Distress Syndrome (ARDS), run by Mayo Clinic at 5 sites 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 3 inclusion and 18 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 5 Sep 2016. 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. 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 5 Sep 2016). 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 Oxygen Saturation to Fraction of Inspired Oxygen Concentration (SpO2/FiO2) Ratio (time frame: baseline to day 5 after the first treatment). The study lists 2 primary outcomes in all. 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 NCT01783821, 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 5 Sep 2016.