RhinitisNCT00281307
Treatment of Rhinitis With Intranasal Vitamin E
A study testing RRR-alpha-tocopherol 1,000 IU/mL in people with Rhinitis, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinitis
- What is being tested?
- RRR-alpha-tocopherol 1,000 IU/mL
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2005to 1 Sep 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DBPCR Clinical Trial for Treatment of Rhinitis With Intranasal Vitamin E
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.
Read the detailed description
Vitamin E has health promoting properties that are attributed to its anti-oxidant action and its ability to stabilize cell membrane and promote restoration of the skin barrier function. The beneficial effects of the topical vitamin E applied to the skin have been firmly established and many skin care products now contain vitamin E, whereas the purported benefits cannot be achieved by oral intake of vitamin E. Recently oral vitamin E was shown to be ineffective in the management of allergic rhinitis, which reminisces the clinical experience in dermatology. The failure of oral vitamin E could result from the relatively low local concentration that are not sufficient to scavenge the reactive oxygen species generated in the inflammatory process and restore the consequent epithelial damage to the nasal mucosa in rhinitis.The effect of topical vitamin E applied intranasally to the mucosa has never been studied. It stands to reason that higher local concentrations can be achieved by topical application of vitamin E directly to the nasal mucosa, which may confer the same positive effects observed with its direct application to the skin. We will perform a single center, prospective, randomized, double-blind, placebo-controlled, clinical trial to investigate the role of topical alpha-tocopherol in oil applied to the nasal mucosa 3 times per day with a q-tip on the subjective symptoms of rhinitis over the course of a 4-week period.
- Conditions
- Rhinitis
- Being tested
- RRR-alpha-tocopherol 1,000 IU/mL
- Keywords
- Rhinitis, Vitamin E, Intranasal
- Medical subject headings
- Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RRR-alpha-tocopherol 1,000 IU/mLDrug
Intranasal application three times daily vs. placebo (inert excipient)
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the Rhinitis/Sinusitis Treatment Outcome Questionnaire (ROQa) composite score at the end of the 4th week
Measured: 4 weeks
Secondary outcomes (4)
Reduction of severity score for each individual symptom
Measured: 4 weeks
Reduction of severity score for the composite symptom score at weekly intervals during the 4-week study period
Measured: 4 weeks
Reduction of severity score for the Sinonasal Outcome Test (SNOT-16) at the end of the study
Measured: 4 weeks
Reduction of severity score for the Mini-RQLQ (Mini Rhinoconjunctivitis Quality of Life Questionnaire) at the end of the study
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2006 (estimated)
- Study start7 Dec 2005
- Primary completion1 Sep 2007
- Study completion1 Sep 2007
Why it 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RhinitisStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soheil Chegini, MD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00281307
- Sponsor's protocol ID
- IRB 21786
- Status last verified
- Jul 2017
- First submitted
- 23 Jan 2006
- Last updated
- 18 Jul 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DBPCR Clinical Trial for Treatment of Rhinitis With Intranasal Vitamin E
- ClinicalTrials.gov ID
- NCT00281307
- Acronym / sponsor ID
- IRB 21786
- Conditions
- Rhinitis
- Keywords
- Rhinitis, Vitamin E, Intranasal
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- 7 Dec 2005 (actual)
- Primary completion
- 1 Sep 2007 (actual)
- Study completion
- 1 Sep 2007 (actual)
- First posted
- 24 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Vitamin E has health promoting properties that are attributed to its anti-oxidant action and its ability to stabilize cell membrane and promote restoration of the skin barrier function. The beneficial effects of the topical vitamin E applied to the skin have been firmly established and many skin care products now contain vitamin E, whereas the purported benefits cannot be achieved by oral intake of vitamin E. Recently oral vitamin E was shown to be ineffective in the management of allergic rhinitis, which reminisces the clinical experience in dermatology. The failure of oral vitamin E could result from the relatively low local concentration that are not sufficient to scavenge the reactive oxygen species generated in the inflammatory process and restore the consequent epithelial damage to the nasal mucosa in rhinitis.The effect of topical vitamin E applied intranasally to the mucosa has never been studied. It stands to reason that higher local concentrations can be achieved by topical application of vitamin E directly to the nasal mucosa, which may confer the same positive effects observed with its direct application to the skin. We will perform a single center, prospective, randomized, double-blind, placebo-controlled, clinical trial to investigate the role of topical alpha-tocopherol in oil applied to the nasal mucosa 3 times per day with a q-tip on the subjective symptoms of rhinitis over the course of a 4-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RRR-alpha-tocopherol 1,000 IU/mLIntranasal application three times daily vs. placebo (inert excipient) | Drug | – |
Primary outcome
Reduction in the Rhinitis/Sinusitis Treatment Outcome Questionnaire (ROQa) composite score at the end of the 4th week
Time frame: 4 weeks
4 secondary outcomes
Reduction of severity score for each individual symptom
Time frame: 4 weeks
Reduction of severity score for the composite symptom score at weekly intervals during the 4-week study period
Time frame: 4 weeks
Reduction of severity score for the Sinonasal Outcome Test (SNOT-16) at the end of the study
Time frame: 4 weeks
Reduction of severity score for the Mini-RQLQ (Mini Rhinoconjunctivitis Quality of Life Questionnaire) at the end of the study
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: 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). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- The Human Subjects Protection Office (HSPO)Link provided by the sponsor.
Related trials for Rhinitis
Not yet recruitingPhase 1
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Chronic Allergic Rhinitis
RecruitingObservational study
A Study to Evaluate Treating Watery Noses With Cryotherapy in the Clinic Setting. This is Cold Therapy, Freezing the Issues at the Back of the Nose to Ease Symptoms.
Chronic Rhinitis
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
RecruitingPhase 3
Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.
Allergic Rhinitis, Allergic Rhinoconjunctivitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soheil Chegini, MD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RRR-alpha-tocopherol 1,000 IU/mL in people with Rhinitis, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the Rhinitis/Sinusitis Treatment Outcome Questionnaire (ROQa) composite score at the end of the 4th week (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2017.