Chronic InflammationPhase 2GWIIRTNCT02506192
Gulf War Illness Inflammation Reduction Trial
A Phase 2 study testing Modified-Release Prednisone in people with Chronic Inflammation and Chronic Pain, run by Minneapolis Veterans Affairs Medical Center at 1 site in United States.
Trial summary
The primary objective of this clinical trial is to determine if treatment with an anti-inflammatory drug (delayed-release prednisone) improves the health-related quality of life (HRQOL) of veterans with Gulf War Illness (GWI). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Inflammation, Chronic Pain, Fatigue
- What is being tested?
- Modified-Release Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 19 Oct 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Scores moderate-severe on at least 3 out of 6 domains from the Kansas GWI Case Definition
- Deployed, (and honorably discharged), from the Kuwaiti Theater of Operation (August 2, 1990-July 31, 1991)
Who cannot join
- Hospitalization anytime since 1990 for Alcohol or Drug Dependence, Depression, or PTSD
- Known hypersensitivity to Prednisone
- Liver, (active or recent Hepatitis B or C treatment with a completion date within the past 6 months, or alcohol liver disease), or Kidney Disease (Hep B and C ok if after 6 months of treatment)
- Treated Diabetes
- Females who are Pregnant or Nursing
- Female who refuses to use an accepted method of birth control
Show all 18Show fewer
- Exclusionary Labs: C-Reactive Protein >25, Creatinine Clearance <30, EFGR ≥ 30, Hgb A1-C >7, Glucose >120, WBC >12, RBC >6.2, Hematocrit >60, Hemoglobin <11, Platelets <100, Liver Function Tests (2 x the upper limit of AST and ALT, 2 x the upper limit of Total Bilirubin, and Alkaline Phosphatase)
- Has Inflammatory Arthritis (RA, or Psoriatic Arthritis, Spondylitis, Polyarthritis)
- Reactive Arthritis, or IBD associated Arthritis
- Has any major inflammatory disease (acute Chronic Infections, Ulcerative Colitis, Crohn's Disease, Inflammatory lung diseases- COPD or Asthma requiring steroid treatment, Pericarditis, Vasculitis)
- Has an chronic/active infection
- Chronic use of Prednisone or Corticosteroids (occasional inhaled use of steroids acceptable)
- Active Gum Disease or Dental Infection
- Has been diagnosed with Lupus, Stroke, or Multiple Sclerosis. or any other diagnosis that produces symptoms of fatigue, cognitive impairment, or pain will be excluded based on the Kansas GWI Case definition
- Has a condition that may interfere with the ability to accurately report symptoms, (Severe Psychiatric Problems, Schizophrenia, Bipolar Disorder, Alcohol or Drug Dependence requiring hospitalization, or regular illegal drug use)
- Heart Disease (other than Hypertension), Heart Failure or Coronary Heart Disease requiring hospitalization within the past 12 months
- Cancer (other than basal cell skin cancer), requiring treatment within the past 12 months, or life expectancy of less than 1 year.
- Hospitalization within the past 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Minneapolis Veterans Affairs Medical Center
Minneapolis, Minnesota, 55417
About this study
The primary objective of this clinical trial is to determine if treatment with an anti-inflammatory drug (delayed-release prednisone) improves the health-related quality of life (HRQOL) of veterans with Gulf War Illness (GWI). The primary outcome measure is a change from baseline of HRQOL with respect to physical functioning and symptoms. Secondary outcomes measures include changes from baseline levels of GWI-associated biomarkers of inflammation in peripheral blood, GWI-associated symptoms (chronic pain, fatigue, and cognitive impairment), and HRQOL with respect to mental functioning.
Read the detailed description
During Desert Shield and Desert Storm (Aug 2, 1990 to July 31,1991) 696,841 United States Military personnel were deployed to the Kuwaiti Theater of Operations. Today approximately one-third of those veterans are suffering from GWI, an unexplained chronic multi-symptom illness. Evidence of chronic inflammation in veterans with GWI has emerged from previous observational studies. The goal of this trial is to determine if reducing the GWI-associated chronic inflammation is an effective treatment for GWI. This is a randomized, two group, placebo controlled, double blind clinical trial. The treatment group will receive a low dose (2x5mg) once a day of delayed-release prednisone (Rayos) for 8 weeks. The placebo group will receive matching placebo (2x5mg) once a day for 8 weeks. The primary outcome measure for this clinical trial is a change from baseline of HRQOL with respect to physical functioning and symptoms. The secondary outcome measures include changes from baseline of peripheral blood levels of GWI-associated biomarkers of inflammation, changes from baseline of GWI-associated symptoms (chronic pain, fatigue, and cognitive impairment), and a change from baseline of HRQOL with respect to mental functioning.
- Conditions
- Chronic Inflammation, Chronic Pain, Fatigue, Cognitive Impairment
- Being tested
- Modified-Release Prednisone, Placebo
- Keywords
- Gulf War Illness, Chronic Inflammation, Modified-Release Prednisone, Health-Related Quality of Life
- Medical subject headings
- Chronic Pain, Fatigue, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified-Release PrednisoneDrug
Also called Rayos
Modified-Release Prednisone oral tablets (2x5mg) daily for 8 weeks
PlaceboDrug
Also called sugar pill, inactive substance
Placebo oral tablets (2x5mg) daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Modified-Release Prednisone | Experimental | Take oral tablets as directed (2x5mg) with food each evening at bedtime- approximately 10:00 pm Receives: Drug: Modified-Release Prednisone |
| Placebo | Placebo comparator | Take oral tablets as directed (2x5mg) with food each evening at bedtime-approximately 10:00 pm Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline of Veterans RAND 36-Item Health Survey Physical Component Summary Score (PCS) Scores at 8 and 16 Weeks
The SF-36V is a modification of the well-established Medical Outcomes Study Short Form Health Survey (SF-36). It surveys eight concepts of health: physical functioning, role limitations because of physical problems, bodily pain, general health perceptions, energy/vitality, social functioning, role limitations due to emotional problems and mental health. From these concepts, two summary component scores are derived: a Physical Component Summary (PCS) and a Mental Component Summary (MCS).
To calculate PCS, scales are standardized with a scoring algorithm or by the scoring software. Scores are standardized and range from 0 to 100, with a US population mean of 50 points and a SD of 10 points. The PCS and the MCS have been demonstrated to have excellent psychometric properties. SF-36V PCS is a measure of HRQOL with respect to physical functioning and symptoms. Higher scores indicate better health status,
Measured: 0, 8, and 16 weeks
Secondary outcomes (5)
Change From Baseline of McGill Pain Questionnaire-short Form (MPQ) Scores at 8 and 16 Weeks
MPQ asks questions about sensory pain, affective pain, pain now, and typical pain
Measured: 0, 8, and 16 weeks
Change From Baseline of Multidimensional Fatigue Inventory (MFI) Scores at 8 and 16 Weeks
MFI asks questions about general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue.
Measured: 0, 8, and 16 weeks
Change From Baseline of Cognitive Failures Questionnaire (CFQ) Scores at 8 and 16 Weeks
CFQ asks questions about cognitive symptoms such as attention, concentration, and memory
Measured: 0, 8, and 16 weeks
Change From Baseline of Veterans RAND 36-Item Health Survey Mental Component Summary Score (MCS) Scores at 8 and 16 Weeks
SF-36V MCS is a measure of HRQOL with respect to mental functioning. The SF-36V is a modification of the well-established Medical Outcomes Study Short Form Health Survey (SF-36). It surveys eight concepts of health: physical functioning, role limitations because of physical problems, bodily pain, general health perceptions, energy/vitality, social functioning, role limitations due to emotional problems and mental health. From these concepts, two summary component scores are derived: a Physical Component Summary (PCS) and a Mental Component Summary (MCS).
To calculate MCS, scales are standardized with a scoring algorithm or by the scoring software. Scores are standardized and range from 0 to 100, with a US population mean of 50 points and a SD of 10 points. The PCS and the MCS have been demonstrated to have excellent psychometric properties. SF-36V MCS is a measure of HRQOL with respect to mental functioning and symptoms. Higher scores indicate better health status,
Measured: 0, 8, and 16 weeks
Change From Baseline of Gulf War Illness-associated Peripheral Blood Biomarkers
Peripheral blood biomarker levels are quantified by multi-analyte profiling (MAP) and complete blood count (CBC) analyses
Measured: 0, 8, and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2015 (estimated)
- Study startJul 2015
- Primary completion19 Oct 2023
- Study completion19 Oct 2023
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 Chronic InflammationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Ronald Bach, Minneapolis Veterans Affairs Medical Center
- Investigators
- Ronald R Bach, PhD, Principal investigator, Minneapolis Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02506192
- Sponsor's protocol ID
- 4554-A
- Acronym
- GWIIRT
- Status last verified
- Nov 2024
- First submitted
- 20 Jul 2015
- Last updated
- 10 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: After publication, all deidentified study data will be made available to other investigators upon request. Data sharing rule of the journal will apply.
Publications
Bach RR, Rudquist RR. Gulf war illness inflammation reduction trial: A phase 2 randomized controlled trial of low-dose prednisone chronotherapy, effects on health-related quality of life. PLoS One. 2023 Jun 15;18(6):e0286817. doi: 10.1371/journal.pone.0286817. eCollection 2023.
PubMed 37319244
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gulf War Illness Inflammation Reduction Trial
- ClinicalTrials.gov ID
- NCT02506192
- Acronym / sponsor ID
- GWIIRT / 4554-A
- Conditions
- Chronic Inflammation, Chronic Pain, Fatigue, Cognitive Impairment
- Keywords
- Gulf War Illness, Chronic Inflammation, Modified-Release Prednisone, Health-Related Quality of Life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Minneapolis Veterans Affairs Medical CenterUS federal agency
- Collaborators
- United States Department of Defense
- Study start
- Jul 2015
- Primary completion
- 19 Oct 2023 (actual)
- Study completion
- 19 Oct 2023 (actual)
- First posted
- 23 Jul 2015 (estimated)
- Results
- Posted 6 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this clinical trial is to determine if treatment with an anti-inflammatory drug (delayed-release prednisone) improves the health-related quality of life (HRQOL) of veterans with Gulf War Illness (GWI). The primary outcome measure is a change from baseline of HRQOL with respect to physical functioning and symptoms. Secondary outcomes measures include changes from baseline levels of GWI-associated biomarkers of inflammation in peripheral blood, GWI-associated symptoms (chronic pain, fatigue, and cognitive impairment), and HRQOL with respect to mental functioning.
Detailed description
During Desert Shield and Desert Storm (Aug 2, 1990 to July 31,1991) 696,841 United States Military personnel were deployed to the Kuwaiti Theater of Operations. Today approximately one-third of those veterans are suffering from GWI, an unexplained chronic multi-symptom illness. Evidence of chronic inflammation in veterans with GWI has emerged from previous observational studies. The goal of this trial is to determine if reducing the GWI-associated chronic inflammation is an effective treatment for GWI. This is a randomized, two group, placebo controlled, double blind clinical trial. The treatment group will receive a low dose (2x5mg) once a day of delayed-release prednisone (Rayos) for 8 weeks. The placebo group will receive matching placebo (2x5mg) once a day for 8 weeks. The primary outcome measure for this clinical trial is a change from baseline of HRQOL with respect to physical functioning and symptoms. The secondary outcome measures include changes from baseline of peripheral blood levels of GWI-associated biomarkers of inflammation, changes from baseline of GWI-associated symptoms (chronic pain, fatigue, and cognitive impairment), and a change from baseline of HRQOL with respect to mental functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified-Release Prednisone | Experimental | Drug: Modified-Release PrednisoneTake oral tablets as directed (2x5mg) with food each evening at bedtime- approximately 10:00 pm |
| Placebo | Placebo comparator | Drug: PlaceboTake oral tablets as directed (2x5mg) with food each evening at bedtime-approximately 10:00 pm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Scores moderate-severe on at least 3 out of 6 domains from the Kansas GWI Case Definition
- Deployed, (and honorably discharged), from the Kuwaiti Theater of Operation (August 2, 1990-July 31, 1991)
Key exclusion criteria (18 listed)
- Hospitalization anytime since 1990 for Alcohol or Drug Dependence, Depression, or PTSD
- Known hypersensitivity to Prednisone
- Liver, (active or recent Hepatitis B or C treatment with a completion date within the past 6 months, or alcohol liver disease), or Kidney Disease (Hep B and C ok if after 6 months of treatment)
- Treated Diabetes
- Females who are Pregnant or Nursing
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 |
|---|---|---|
| Modified-Release PrednisoneAlso: RayosModified-Release Prednisone oral tablets (2x5mg) daily for 8 weeks | Drug | Modified-Release Prednisone |
| PlaceboAlso: sugar pill, inactive substancePlacebo oral tablets (2x5mg) daily for 8 weeks | Drug | Placebo |
Primary outcome
Change From Baseline of Veterans RAND 36-Item Health Survey Physical Component Summary Score (PCS) Scores at 8 and 16 Weeks
Time frame: 0, 8, and 16 weeks
The SF-36V is a modification of the well-established Medical Outcomes Study Short Form Health Survey (SF-36). It surveys eight concepts of health: physical functioning, role limitations because of physical problems, bodily pain, general health perceptions, energy/vitality, social functioning, role limitations due to emotional problems and mental health. From these concepts, two summary component scores are derived: a Physical Component Summary (PCS) and a Mental Component Summary (MCS). To calculate PCS, scales are standardized with a scoring algorithm or by the scoring software. Scores are standardized and range from 0 to 100, with a US population mean of 50 points and a SD of 10 points. The PCS and the MCS have been demonstrated to have excellent psychometric properties. SF-36V PCS is a measure of HRQOL with respect to physical functioning and symptoms. Higher scores indicate better health status,
5 secondary outcomes
Change From Baseline of McGill Pain Questionnaire-short Form (MPQ) Scores at 8 and 16 Weeks
Time frame: 0, 8, and 16 weeks
Change From Baseline of Multidimensional Fatigue Inventory (MFI) Scores at 8 and 16 Weeks
Time frame: 0, 8, and 16 weeks
Change From Baseline of Cognitive Failures Questionnaire (CFQ) Scores at 8 and 16 Weeks
Time frame: 0, 8, and 16 weeks
Change From Baseline of Veterans RAND 36-Item Health Survey Mental Component Summary Score (MCS) Scores at 8 and 16 Weeks
Time frame: 0, 8, and 16 weeks
Change From Baseline of Gulf War Illness-associated Peripheral Blood Biomarkers
Time frame: 0, 8, and 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37319244Bach RR, Rudquist RR. Gulf war illness inflammation reduction trial: A phase 2 randomized controlled trial of low-dose prednisone chronotherapy, effects on health-related quality of life. PLoS One. 2023 Jun 15;18(6):e0286817. doi: 10.1371/journal.pone.0286817. eCollection 2023.
- link to citationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. After publication, all deidentified study data will be made available to other investigators upon request. Data sharing rule of the journal will apply.
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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.
Ronald R Bach, PhD principal investigator
Minneapolis Veterans Affairs Medical 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 Modified-Release Prednisone in people with Chronic Inflammation and Chronic Pain, run by Minneapolis Veterans Affairs Medical Center 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 2 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 10 Dec 2024. 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?
Yes. Results are posted in the registry (first posted 6 Dec 2023). 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 From Baseline of Veterans RAND 36-Item Health Survey Physical Component Summary Score (PCS) Scores at 8 and 16 Weeks (time frame: 0, 8, and 16 weeks). 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 NCT02506192, 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 10 Dec 2024.