Clinical TrialID 6605

Smell Changes & Efficacy of Nasal Theophylline

NCT03990766

Olfactory Disorder|Anosmia|Viral Infection|Theophylline Causing Adverse Effects in Therapeutic Use|Smell Disorder

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
6605
Evidence Id
6605
Core Evidence Id
6605
Source Clinical Trial Id
6592
Herb2 Clinical Trial Id
HBCT006592
Nct Id
NCT03990766
Title
Smell Changes & Efficacy of Nasal Theophylline
Status
Completed
Phase
Phase 2
Study Result
Yes
Study Condition
Olfactory Disorder|Anosmia|Viral Infection|Theophylline Causing Adverse Effects in Therapeutic Use|Smell Disorder
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Intervention
DRUG: Theophylline|DRUG: Saline Nasal
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Quadruple
Intervention Purpose
Treatment
Gender
All
Age
Adult, Older_Adult
Enrollment
27
Outcome Measure
Number of Patients With Improvement in Global Rating of Smell Change, Self-reported change in smell after intervention on a 7-point Likert scale. Response options with corresponding point values: 7) Much better, 6) Somewhat better, 5) Slightly better, 4) Neither better nor worse, 3) Slightly worse, 2) Somewhat worse, and 1) Much worse. The maximum score is 7, and higher values indicate better outcomes. A score of 4 is considered neutral. Scores of 5 or higher indicated clinical improvement., 6 weeks
Sponsor Collaborator
Washington University School of Medicine
Funded By
OTHER
Location
Washington University in St. Louis, Saint Louis, Missouri, 63110, United States
Other Id
201901107
Start Date
2019-05-15
Primary Completion Date
2021-01-15
Completion Date
2021-01-15
First Posted
2019-06-19
Results First Posted
2022-03-31
Last Update Posted
2022-03-31
Study Document
Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/66/NCT03990766/Prot_SAP_000.pdf|Informed Consent Form, https://cdn.clinicaltrials.gov/large-docs/66/NCT03990766/ICF_001.pdf
Study Url
https://clinicaltrials.gov/study/NCT03990766
Title Cn
Title En
Smell Changes & Efficacy of Nasal Theophylline
Bilingual Status
semi_complete