Gulf War Illness Nasal Irrigation Study

NCT01700725 | Completed Phase 2 Results

• 2 other identifiers: GW100054 US Dept of Defense2011-0843
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether nasal irrigation with Xylitol or saline are effective in the treatment of chronic rhinosinusitis and fatigue symptoms associated with Gulf War Illness.

Conditions

Persian Gulf Syndrome; Chronic Sinusitis; Fatigue; Acute Sinusitis

Keywords

Gulf War Illness; xylitol; nasal irrigation; Desert Storm; Persian Gulf Conflicts; neti pot; cytokines; nasal mucus; inflammatory mediator; lactoferrin; lysozyme

Outcome Measures

Primary Outcomes (1)

• Change in Sino-Nasal Outcome Test (SNOT-20) Score From Baseline

  Sino-Nasal Outcome Test (SNOT-20) is a recommended tool for clinical trial research involving CRS. Sinus disease specific quality of life will be measured using the total score of this validated 20 item questionnaire. It is a reliable and valid outcome measure for patients with CRS (Cronbach's α 0.9, test-retest r = 0.9) that describes the health burden and is sensitive to clinical change. Patients who are more affected by CRS tend to have greater SNOT-20 scores (P \< 0.01). The SNOT-20 score is expected to improve in NI-treated subjects compared to controls. Findings of the PI's prior RCT of adults with CRS are consistent with the above evidence. The total range of possible scores is 0-100. The higher the score, the worse the symptoms.

  Change from baseline week 8, change from baseline week 26

Secondary Outcomes (2)

• Change in Multidimensional Fatigue Inventory (MFI) Over Baseline

  Baseline to weeks 8 & 26

• Change in Medical Outcomes Survey Short Form-36 (SF-36) Over Baseline

  Baseline and weeks 8 & 26

Study Arms (3)

Nasal Irrigation - Saline

EXPERIMENTAL

nasal irrigation using saline plus routine care for symptoms of CRS and fatigue

Other: Nasal Irrigation - Saline

Nasal Irrigation - Xylitol

EXPERIMENTAL

Nasal Irrigation with Xylitol plus routine care for symptoms of CRS and fatigue

Drug: Nasal Irrigation - Xylitol

Control Group

NO INTERVENTION

Control group subjects continue to use routine care only

Interventions

Nasal Irrigation - Saline OTHER

Liquid-based nasal irrigation (NI) is performed using a nasal irrigation cup ("neti pot"), a simple hand-held vessel that uses the force of gravity to gently irrigate the user's nasal cavity. Subjects will be requested to perform NI twice daily. The subjects will prepare the saline solution by themselves using the study-provided kit which will include packets of salt powder and the neti pot; subjects will dissolve the powder in lukewarm tap water to achieve a 2% buffered saline solution. The solution is then delivered to the nasal cavity using neti pot.

Also known as: 2% buffered saline

Nasal Irrigation - Saline

Nasal Irrigation - Xylitol DRUG

Liquid-based nasal irrigation (NI) is performed using a nasal irrigation cup ("neti pot"), a simple hand-held vessel that uses the force of gravity to gently irrigate the user's nasal cavity. Subjects will be requested to perform NI twice daily. The subjects will prepare the Xylitol solution by themselves using the study-provided kit which will include packets of Xylitol powder and the neti pot; subjects will dissolve the powder in lukewarm tap water to achieve a 5% Xylitol solution. The solution is then delivered to the nasal cavity using neti pot.

Also known as: 5% Xylitol solution

Nasal Irrigation - Xylitol

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English fluency and basic reading and writing literacy.
• Deployment to the Persian Gulf (e.g., Iraq, Kuwait, Saudi Arabia) for the purpose of Operation Desert Shield or Operation Desert Storm during the first Gulf War (1990-1991).
• Meeting criteria for a diagnosis of GWI as based on the "Kansas" GWI case definition; only the Kansas case definition (from among the several currently used case definitions) can differentiate between Gulf War-deployed and non-deployed Gulf era veterans.
• Meeting criteria for a diagnosis of chronic rhinosinusitis (CRS) using self-reported symptoms and based on clinical guidelines; eligible subjects will report: • sinonasal symptoms for at least 12 weeks; • a constellation of sinonasal symptoms including either two or more major factors, or 1 major and 2 minor factors (see Table 1 below), or chronic nasal purulence for 12 or more weeks; and • a moderate to severe HRQoL impact (≥ 3 points on a 0-10 Likert severity scale) as assessed by a single item question:11 "What has been the average level of your sinus symptoms daily over the past month on a 0-10 scale?" This item is consistent with eligibility criteria used in prior NI studies.
• Chronic fatigue of moderate-to-severe severity defined as scoring at least 3 points on a single question (0-10 Likert scale): "What has been the average level of your daily fatigue over the past month on a 0-10 scale?"

You may not qualify if:

• Self-reported pregnancy.
• Current use of liquid NI or xylitol nasal spray; regular use is defined as 1 or more irrigations weekly for 3 consecutive weeks.
• Self-reported neurological or musculoskeletal conditions that could facilitate aspiration, or patients who otherwise cannot physically perform the NI procedure.
• Self-reported borderline personality disorder.
• Inability or stated reluctance to reliably participate in study activities.
• Severe or unstable mental health problems that would preclude safe or reliable study participation as based on an in-person evaluation by a psychiatry team; active delusional disorder, depressive disorder or alcohol/drug abuse or dependence will be a primary target of this interview using both a structured clinical interview (MINI ref) and psychiatry team evaluation.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin General Clinical Research Center

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• Hayer SD, Rabago DP, Amaza IP, Kille T, Coe CL, Zgierska A, Zakletskaia L, Mundt MP, Krahn D, Obasi CN, Molander RC. Effectiveness of nasal irrigation for chronic rhinosinusitis and fatigue in patients with Gulf War illness: protocol for a randomized controlled trial. Contemp Clin Trials. 2015 Mar;41:219-26. doi: 10.1016/j.cct.2015.01.008. Epub 2015 Jan 24.

  PMID: 25625809 DERIVED

MeSH Terms

Conditions

Persian Gulf Syndrome; Fatigue

Condition Hierarchy (Ancestors)

Occupational Diseases; War-Related Injuries; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: David Rabago, MD
• Organization: University of Wisconsin - Madison

david.rabago@fammed.wisc.edu

608-843-0850

Study Officials

• Rachel Molander, MD

  US Department of Veterans Affairs, William S. Middleton Memorial Veterans Hospital

  PRINCIPAL INVESTIGATOR

• David P Rabago, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2012
• First Posted: October 4, 2012
• Study Start: October 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: May 1, 2017
• Last Updated: May 21, 2019
• Results First Posted: May 21, 2019

Record last verified: 2019-05

Locations

US (1)