Seasonal Allergic RhinitisPhase 4NCT01103934
Vitamin D Plus Fluticasone Propionate
A Phase 4 study testing Vitamin D3 and Fluticasone Propionate in people with Seasonal Allergic Rhinitis, run by University of Chicago at 1 site in United States.
Trial summary
The objectives of this study would be to see if the addition of vitamin D to fluticasone propionate provides greater symptomatic relief in patients with seasonal allergic rhinitis compared to fluticasone propionate treatment alone. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Vitamin D3 and Fluticasone Propionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jul 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females between 18 and 45 years of age.
- History of tree, grass and/or ragweed allergic rhinitis.
- Positive skin test to tree, grass and/or ragweed antigen.
- Positive response to screening nasal challenge.
Who cannot join
- Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Pregnant or lactating women.
- Upper respiratory infection within 14 days of study start.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Addition of Vitamin D to Fluticasone Propionate in the Management of Seasonal Allergic Rhinitis
The objectives of this study would be to see if the addition of vitamin D to fluticasone propionate provides greater symptomatic relief in patients with seasonal allergic rhinitis compared to fluticasone propionate treatment alone.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Vitamin D3, Placebo, Fluticasone Propionate
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
4000 IU once daily
PlaceboDrug
Placebo taken once daily
Fluticasone PropionateDrug
Also called Flonase
200 mcg daily, intranasal
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone Propionate plus Vitamin D3 | Active comparator | Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season Receives: Drug: Vitamin D3; Drug: Fluticasone Propionate |
| Fluticasone Propionate plus Placebo | Placebo comparator | Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season Receives: Drug: Placebo; Drug: Fluticasone Propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period
Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms.
Measured: Baseline and 2 weeks
Secondary outcomes (1)
Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period
Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The DNSS was calculated as the sum of all scores for morning with a range of 0 to 12. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in daytime symptoms.
Measured: Baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert M Naclerio, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103934
- Sponsor's protocol ID
- 10-184-B
- Status last verified
- Oct 2014
- First submitted
- 13 Apr 2010
- Last updated
- 9 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Addition of Vitamin D to Fluticasone Propionate in the Management of Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01103934
- Acronym / sponsor ID
- 10-184-B
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 15 Apr 2010 (estimated)
- Results
- Posted 9 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study would be to see if the addition of vitamin D to fluticasone propionate provides greater symptomatic relief in patients with seasonal allergic rhinitis compared to fluticasone propionate treatment alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluticasone Propionate plus Vitamin D3 | Active comparator | Drug: Vitamin D3, Drug: Fluticasone PropionateSubjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season |
| Fluticasone Propionate plus Placebo | Placebo comparator | Drug: Placebo, Drug: Fluticasone PropionateSubjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and females between 18 and 45 years of age.
- History of tree, grass and/or ragweed allergic rhinitis.
- Positive skin test to tree, grass and/or ragweed antigen.
- Positive response to screening nasal challenge.
Key exclusion criteria (3 listed)
- Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Pregnant or lactating women.
- Upper respiratory infection within 14 days of study start.
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 |
|---|---|---|
| Vitamin D34000 IU once daily | Drug | Fluticasone Propionate plus Vitamin D3 |
| PlaceboPlacebo taken once daily | Drug | Fluticasone Propionate plus Placebo |
| Fluticasone PropionateAlso: Flonase200 mcg daily, intranasal | Drug | Fluticasone Propionate plus Placebo, Fluticasone Propionate plus Vitamin D3 |
Primary outcome
Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period
Time frame: Baseline and 2 weeks
Patients recorded the severity of sneezing, runny nose, stuffy nose, and other symptoms (e.g. itchy nose/throat) twice a day on a scale from 0 to 3 (0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe). The TNSS was calculated as the sum of all scores for morning and evening recordings with a range of 0 to 24. The change from baseline for each day of treatment was then calculated for each subject. So that each subject only had one observation, the average of these changes was calculated for each subject, and this summary measure was used in the analysis comparing the two treatment groups. We report the median and full range of these average changes for each group. A negative value indicates an improvement in symptoms.
1 secondary outcome
Change From Baseline in Daytime Nasal Symptom Score (DNSS) Over 2 Week Randomized Treatment Period
Time frame: Baseline and 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Robert M Naclerio, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D3 and Fluticasone Propionate in people with Seasonal Allergic Rhinitis, run by University of Chicago 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 4 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: finished, as of the sponsor's last update on 9 Oct 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Total Nasal Symptom Score (TNSS) Over 2 Week Randomized Treatment Period (time frame: Baseline and 2 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 9 Oct 2014.