INTERVENTION STUDY FOR THE RELIEF OF ORAL DRYNESS – NOVOSPRAY

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

•Male or female, over 18 years of age, and capable of providing their written informed consent.
•An unstimulated whole mouth salivary flow < 0.20 ml/min [8].
•Demonstrated moderate to severe level of dry mouth at screening, as indicated by an XI-score of 25 or higher
•Diagnosis of Sjögren's syndrome.
•Access to internet.

Exclusion Criteria

•Patients currently using a potassium-sparing diuretic antihypertensive drug that contains amiloride; spironolactone (e.g.,Aldactone, Novo-Spiroton, Spiractin, Spirtone, Verospiron or Berlactone); triamterene (e.g., Dyrenium); or plerenone (e.g., Inspra). Chronic use of antihistamines will be permitted if started at least 30 days before the start of the trial, and a stable dose is maintained throughout the trial.
•Patients who started using systemic cholinergic secretagogues or tricyclic antidepressant drugs within 12 weeks before screening, patients who are not on a stable dosing regimen for at least 14 days prior to the screening visit, or patients who are unable to maintain stable dosing throughout the study.
•Females who are pregnant or trying to become pregnant, or are nursing.
•Patients showing evidence of a significant active or ongoing oral infection or other oral conditions (eg, lichen planus) that, in the opinion of the Investigator, might affect the safety of the subject or be exacerbated during study participation.
•Patients suffering from acute infections of the salivary glands.
•Patients with a present history of any clinically significant and uncontrolled neurologic, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, or hematological disorder or disease, or any other major disorder or disease, in the opinion of the Investigator.
•Patients consuming more than 2 alcoholic drinks per day or with a significant history of alcoholism or drug/chemical abuse within the past 12 months.
•Patients who have received an investigational drug within the past 30 days.
•Patients with a history of allergy to chicken egg proteins or food preservatives
•Patients having an unstimulated whole mouth salivary flow > 0.20 ml/min.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to evaluate the effect of an artificial saliva substitute on the sensation of a dry mouth. <br>This will be measured according to a VAS questionnaire for subjective assessment of salivary dysfunction.<br>In addition, the Xerostomia Inventory will be used to quantify the severity of oral dryness.<br>

Secondary Outcome Measures

Name	Time	Method
A secondary objective of this study is to evaluate the overall appreciation of the saliva substitute. This objective will be assessed by a product appraisal questionnaire. Another secondary objective is to evaluate effects of the artificial saliva on the saliva secretion rate.

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