Nebulizer Delivery of Intranasal Scopolamine (NCT04999449) | Clinical Trial Compass
CompletedPhase 1
Nebulizer Delivery of Intranasal Scopolamine
United States14 participantsStarted 2022-01-24
Plain-language summary
To develop a better way to administer anti-motion sickness medications using an intranasal nebulizer.
Who can participate
Age range21 Years – 49 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female
* Adults age 21-49
* Normal weight for body size, based on BMI table
* General good health, as determined by a verbally provided medical history
* Normal brief neurological exam
* Renal and hepatic function within normal ranges
* Able to provide written informed consent to participate
Exclusion Criteria:
* Drug allergies to scopolamine or other belladonna alkaloid
* Use of medications within 1 week of starting the study
* Use of an investigational drug within 30 days of starting the study
* Tobacco smoking within the past year
* Blood donation or significant blood loss within 30 days of starting the study
* Significant gastrointestinal disorder (e.g. Crohn's Disease, ulcerative colitis, chronic constipation), asthma, glaucoma, prostate problems, urinary obstruction, or seizure disorders
* History of alcohol or other drug abuse
* Pregnancy or suspected pregnancy, or lactation (pregnancy will be confirmed with urine pregnancy testing prior to drug administration)
* Consumption of grapefruit juice within 7 days of scopolamine (SCOP) administration
* Nasal, nasal sinus, or nasal mucosa surgery within 90 days prior to study initiation
* Other significant surgeries within 90 days
* Significant deviated septum that blocks air flow in one nostril
* Rhinitis, sinus infection, severe allergies, and other upper respiratory infections within 30 days prior to the study
* Current use of an intranasal medication
* Wheezing or other respiratory problem…
What they're measuring
1
Time to maximal concentration for scopolamine after intranasal administration (Tmax)
Timeframe: Baseline, 180 minutes
2
Side effects of intranasal scopolamine, as measured through a questionnaire with a subjective rating scale