Study Stopped
Due to a substantial response to placebo an interim analysis indicated the need for a larger than expected study population to achieve the level of significance
Treatment of Rhinitis With Intranasal Vitamin E
DBPCR Clinical Trial for Treatment of Rhinitis With Intranasal Vitamin E
1 other identifier
interventional
10
1 country
1
Brief Summary
Many beneficial effects of vitamin E have been described, but vitamin E supplementation by mouth has not been effective in the treatment of nasal symptoms and allergic rhinitis. The investigators will evaluate the effect of vitamin E directly applied to the lining of the nose in individuals with moderate to severe rhinitis by symptom questionnaires.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 7, 2005
CompletedFirst Submitted
Initial submission to the registry
January 23, 2006
CompletedFirst Posted
Study publicly available on registry
January 24, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedJuly 18, 2017
July 1, 2017
1.7 years
January 23, 2006
July 13, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in the Rhinitis/Sinusitis Treatment Outcome Questionnaire (ROQa) composite score at the end of the 4th week
4 weeks
Secondary Outcomes (4)
Reduction of severity score for each individual symptom
4 weeks
Reduction of severity score for the composite symptom score at weekly intervals during the 4-week study period
4 weeks
Reduction of severity score for the Sinonasal Outcome Test (SNOT-16) at the end of the study
4 weeks
Reduction of severity score for the Mini-RQLQ (Mini Rhinoconjunctivitis Quality of Life Questionnaire) at the end of the study
4 weeks
Interventions
Intranasal application three times daily vs. placebo (inert excipient)
Eligibility Criteria
You may qualify if:
- Clinical symptoms of rhinitis and symptom severity score of 25 or higher on the self-administered Rhinosinusitis Questionnaire (range of 0, i.e. absence of any symptom, to 50, which indicates the most severe symptom in each category)
You may not qualify if:
- Inability to give informed consent, comprehend questions or instructions and complete questionnaires
- Recent change (within 2 weeks) in the medications that may affect nasal or sinus symptoms (intranasal or systemic glucocorticosteroids, mast cell stabilizer, antihistamines, decongestants, leukotriene antagonist, antibiotics, preparations containing thyroid or sex hormones, alpha-blocking agents)
- Intranasal use of oil- or gel-based products
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cathy Mende, CRNP
Hershey, Pennsylvania, 17033, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Soheil Chegini, MD
Penn State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2006
First Posted
January 24, 2006
Study Start
December 7, 2005
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
July 18, 2017
Record last verified: 2017-07