A Randomized Within-Subject, Double-Blind, Placebo-Controlled Study of Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome Subjects
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change in Parotid Salivary Flow From Baseline (Day 0) to Day 56.
研究概览
简要总结
Background:
Sjögren's syndrome is an autoimmune disease (where the immune system attacks normal body tissues) that affects the salivary glands. Many people with Sjögren's syndrome are not able to make enough saliva because their salivary glands are inflamed. The dry mouth that results can interfere with daily activities and can lead to dental cavities, mouth sores, and infections. Injections of corticosteroids into the parotid glands can improve saliva production in people with Sjögren's syndrome, but current treatment practices may provide only temporary relief. Researchers are interested in studying the effectiveness of stronger corticosteroid injections (using dexamethasone) to determine how the corticosteroid treatment actually works.
Objectives:
- To evaluate the effectiveness and mechanics of dexamethasone injections to improve saliva production in individuals with primary Sjögren's syndrome.
Eligibility:
- Women between 18 and greater of age who have been diagnosed with primary Sjögren's syndrome, and have had a biopsy of the minor salivary glands in the past 5 years that shows a moderate level of inflammation.
Design:
- Participants will be screened with a full medical history and physical examination, blood and urine tests, and salivary gland biopsies. Participants will also be screened with tests of saliva flow production and evaluation of the salivary ducts and glands, and will complete questionnaires about dry mouth symptoms.
- At the first treatment visit, participants will receive an injection of dexamethasone into one parotid gland and an injection of saline into the other gland. After the injections, participants will provide a blood sample to test the level of dexamethasone in the blood.
- Two weeks after the first treatment, participants will return for an evaluation visit to have saliva flow rate measurements taken, and will complete a questionnaire about dry mouth symptoms.
- Four weeks after the first treatment, participants will have a second treatment for each parotid gland, with the same tests and questionnaires as before.
- Participants will have additional evaluation visits 6 and 8 weeks after the first treatment visit, with a followup telephone call approximately 6 weeks after the last dexamethasone treatment visit.
详细描述
BACKGROUND:
Salivary gland dysfunction is one of the major manifestations of Sjögren's (SS). Although inflammation is thought to play an important role in the exocrinopathy, the correlation between glandular dysfunction and inflammation is limited. Systemic anti-inflammatory therapies tested to date, such as tumor necrosis factor antagonists, have not been effective treatments for SS salivary hypofunction, raising doubts about inflammation being the sole cause of salivary gland dysfunction. However, none of these trials tested whether an anti-inflammatory effect was achieved in glandular tissues.
Studies by Izumi et al found that a limited course of low-dose topical corticosteroid applied to the parotid glands resulted in sustained improvement in saliva production. Unfortunately, these studies did not examine the mechanistic effects of corticosteroids on the major salivary glands. A plausible assumption is that corticosteroids improved salivary gland function by reducing inflammation, although other or associated mechanisms, such as an improved transcellular ion transport in epithelial cells cannot be ruled out. This study aims to study the efficacy of low-dose topical corticosteroid (dexamethasone) irrigation of the parotid gland in reducing salivary dysfunction in subjects with SS, and also to evaluate the effects of treatment on inflammation and other possible mechanistic processes.
PRIMARY OBJECTIVE:
- To determine whether irrigation of the parotid gland with low-dose topical dexamethasone improves parotid salivary gland flow in SS subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo Parotid Irrigation
Within-Subject, Double-Blind, Placebo-Controlled Study. This parotid gland is irrigated with saline (placebo). { UPDATE: drug(generic) was administered at what time pt, dose of drug, route administration, frequency}
干预措施: Placebo Parotid Irrigation (Drug)
Dexamethasone Parotid Irrigation
Within-Subject, Double-Blind, Placebo-Controlled Study. This parotid gland is irrigated with dexamethasone {UPDATE: drug (generic) was administered at what time pt, dose of drug, route administration, frequency}
干预措施: Dexamethasone Parotid Irrigation (Drug)
结局指标
主要结局
Change in Parotid Salivary Flow From Baseline (Day 0) to Day 56.
时间窗: Baseline (Study Day 0) to Study Day 56
Saliva flow rate was determined by weighing the saliva flow collected separately from each parotid (dexamethasone irrigated and placebo irrigated parotid) within a participant and dividing by collection time. Saliva was collected using a Teflon collection cup placed over the parotid duct orifice and held in place by slight negative pressure. Collection time was 1 minute. The primary outcome measure is looking at change from baseline at Study Day 56 and not the flow at any particular time.
次要结局
- Patient Dry Mouth Questionnaire. Question: Do You Have More Difficulty Chewing Your Food Since Starting the Study?(Baseline (Study Day 0) through Study Day 56)
- Patient Dry Mouth Questionnaire. Question: Have You Experienced Any Changes in Your Sense of Smell Since Starting the Study?(Baseline (Study Day 0) through Study Day 56)
- Change in Parotid Salivary Flow From Baseline (Day 0) to Day 28.(Baseline to 28 days post-baseline)
- Change in Parotid Salivary Flow From Baseline (Day 0) to Day 42.(Baseline to 42 days post-baseline)
- Patient Dry Mouth Questionnaire: Have You Experienced Any Changes in Your Sense of Taste Since Starting the Study?(Baseline (Study Day 0) through Study Day 56)
- Change in Parotid Salivary Flow From Baseline (Study Day 0) to Study Day 14.(Baseline to 14 days post-baseline)
- Patient Dry Mouth Questionnaire. Question: If You Have More Difficulty Chewing Your Food Since Starting the Study, Why?(Baseline (Study Day 0) through Study Day 56)
- Patient Dry Mouth Questionnaire: Do You Use Anything to Keep Your Mouth Moist?(Baseline (Study Day 0) through Study Day 56)
- Patient Dry Mouth Questionnaire: Do You Have More Difficulty Swallowing Dry Foods Without Additional Liquids Since Starting the Study?(Baseline (Study Day 0) through Study Day 56)
- Patient Dry Mouth Questionnaire: If You Have Experienced Any Changes in Your Sense of Taste Since Starting the Study, Specify:(Baseline (Study Day 0) through Study Day 56)
- Patient Dry Mouth Questionnaire: Do You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study?(Baseline (Study Day 0) through Study Day 56)
- Patient Dry Mouth Questionnaire: If You Have Any More Pain or Burning in Your Mouth or Head and Neck Region Since Starting the Study, Specify:(Baseline (Study Day 0) through Study Day 56)
- Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry When You Eat a Meal Since Starting the Study?(Baseline (Study Day 0) through Study Day 56)
- Patient Dry Mouth Questionnaire Shift Table. Question: More Difficulty Chewing Food?(Baseline (Study Day 0) through Study Day 56)
- Patient Dry Mouth Questionnaire: Does the Amount of Saliva in Your Mouth Most of the Time Seem to be:(Baseline (Study Day 0) through Study Day 56)
- Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Smell?(Baseline (Study Day 0) through Study Day 56)
- Patient Dry Mouth Questionnaire Shift Table. Question: Pain/Burning in Mouth or Head/Neck?(Baseline (Study Day 0) through Study Day 56)
- Sjögren's Disease Activity Index: Compared With Baseline, do You Consider Your Patient Presents a Systemic Flare of the Participant's pSS (Primary Sjögren's Syndrome):(Baseline (Study Day 0) through Study Day 56)
- Patient Dry Mouth Questionnaire: If You Use Something to Keep Your Mouth Moist, Specify:(Baseline (Study Day 0) through Study Day 56)
- Patient Dry Mouth Questionnaire: Does Your Mouth Feel More Dry Other Times of the Day Since Starting the Study?(Baseline (Study Day 0) through Study Day 56)
- Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry Other Times of Day?(Baseline (Study Day 0) through Study Day 56)
- Patient Dry Mouth Questionnaire Shift Table. Question: Difficulty Swallowing Dry Foods Without Liquids?(Baseline (Study Day 0) through Study Day 56)
- Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Ordinal Numeric Scale)(Baseline (Study Day 0) through Study Day 56)
- Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 42 , Ordinal Scores(Baseline (Study Day 0) through Study Day 42)
- Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 14, Ordinal Scale(Baseline (Study Day 0) to Study Day 14)
- Patient Dry Mouth Questionnaire Shift Table. Question: Changes in Sense of Taste?(Baseline (Study Day 0) through Study Day 56)
- Patient Dry Mouth Questionnaire Shift Table. Question: Use Anything to Keep Mouth Moist?(Baseline (Study Day 0) through Study Day 56)
- Patient Dry Mouth Questionnaire Shift Table. Question: Mouth Feel More Dry When You Eat?(Baseline (Study Day 0) through Study Day 56)
- Sjögren's Disease Activity Index Shift Table. Question: Do You Consider Your Patient in a Satisfactory State of "Minimal Disease Activity? The Shift Table Data Was Not Rich Enough to Perform McNemar's Test on the Shift Tables of Any of the Study Days.(Baseline (Study Day 0) through Study Day 56)
- Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 28 , Ordinal Scores(Baseline (Study Day 0) through Study Day 28)
- Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 56 , Ordinal Scores(Baseline (Study Day 0) through Study Day 56)
- Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale) the Shift From Baseline to the Given Study Day, Nominal Scale(Baseline (Study Day 0) to Study Day 56)
- Shift Table of Focus Scores From Stage II Screening to Study Day 56(Stage II Screening (within 6 wks before baseline) through 56 days post-baseline)
- Sjögren's Disease Activity Index: Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient (Nominal Scale)(Baseline (Study Day 0) through Study Day 56)
- Sjögren's Disease Activity Index: Do You Consider Your Patient in a Satisfactory State of 'Minimal Disease Activity'?(Baseline (Study Day 0) through Study Day 56)
- Sjögren's Disease Activity Index: Indicate the Level of Disease Activity in This Patient, Taking Into Account the Symptoms of Your Patient's (Dryness, Pain, Physical and Mental Fatigue), Ordinal Scores(Baseline (Study Day 0) through Study Day 56)
- Sjörgen's Disease Activity Index, Shift Table of Disease Activity Based on Patient's Symptoms From Baseline to Study Day 14 , Ordinal Scores(Baseline (Study Day 0) through Study Day 14)
- Shift Table of the Change in Parotid Technetium Scan at Study Day 56 From Stage II Screening Visit(Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56)
- Sjögren's Disease Activity Index: Compared With Baseline, This Participant's Primary Sjögren's Syndrome (pSS) Activity is Now:(Baseline (Study Day 0) through Study Day 56)
- Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 28, Ordinal Scale(Baseline (Study Day 0) to Study Day 28)
- Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 42, Ordinal Scale(Baseline (Study Day 0) to Study Day 42)
- Sjörgen's Disease Activity Index (SDAI): Indicate, According to Your Clinical Experience, the Level of Disease Activity in This Patient the Shift From Baseline to Study Day 56, Ordinal Scale(Baseline (Study Day 0) to Study Day 56)
- Summary Statistics of MRI Scans(Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56)
- Summary Statistics of Technetium Scans(Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56)
- Shift Table of the Change in Parotid MRI at Study Day 56 From Stage II Screening Visit(Stage II Screening (within 6 wks before Baseline (Study Day 0)) through Study Day 56)
- Summary Statistics of Focus Score(Stage II screening (within 6 wks before baseline) through 56 days post-baseline)