Seasonal Allergic RhinitisNCT00755066
Effect of Intranasal Corticosteroids on Systemic Allergen Specific IgE
A study testing Fluticasone propionate in people with Seasonal Allergic Rhinitis, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Evaluation of the effect of fluticasone propionate vs placebo applied as nasal spray on the increase of allergen-specific serum IgE levels following nasal exposure to recombinant allergens. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Fluticasone propionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteAustria
- Study dates
- Start not givento not given
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- male or female 18-50 years of age
- moderate to severe allergic rhinitis to grass and/or birch pollen for at least two seasons according to history
- sensitization to rPhl p 5 and rBet v 1 as demonstrated by UniCAP within a range from 3.0-80 kUA/l and a positive (wheal diameter >= 3 mm larger than the negative control and half of the histamine control) SPT with rPhl p 5 and rBet v 1 at 20 µg/ml
- willingness to comply with the study protocol
- written informed consent
Who cannot join
- perennial allergic rhinitis
- history of asthma necessitating treatment
- FEV1 <70% of predicted value
- abnormalities at auscultation of heart or lungs
- history of anaphylaxis
- severe atopic dermatitis
Show all 35Show fewer
- total serum IgE >2000 kU/l
- previous or ongoing immunotherapy (subcutaneous or sublingual) to grass or birch pollen
- nasal provocation testing during the previous six month
- known allergy/intolerance to fluticasone propionate or loratadine
- known allergy/intolerance to cellulose, polysorbate, phenylethyl alcohol, benzalkonium chloride
- contraindications for the use of INCS:
- acute or chronic infections of the upper respiratory tract
- surgery of the nose during the previous year
- hypersensitivity to components of the drug
- contraindications for nasal provocation test
- acute rhinosinusitis
- acute allergic reaction of the immediate type at other organs
- nasal polyposis or significant nasal anatomical deformities
- vasomotor rhinitis
- autoimmune disease, chronic or acute infectious disease, malignancy
- severe psychological disorder
- treatment with systemic or topical (intranasal, inhaled, external) corticosteroids from 3 month prior to the study
- treatment with other immunosuppressant drugs from 6 month prior to the study
- treatment with antihistamines or disodium cromoglycate from 2 weeks prior to the study
- treatment with intranasal adrenergic drugs from 3 days prior to the study
- treatment with systemic adrenergic drugs
- treatment with psychopharmacological drugs from 2 weeks prior to the study
- cardiovascular or pulmonary disease
- contraindication for adrenaline
- participation in any other clinical trial within the previous 3 month
- pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method
- a mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude
- known alcohol or drug addiction or abuse
- unlikelihood to be able to complete the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intranasal Corticosteroid on the Immune Response Following Nasal Allergen Challenge in Patients Suffering From Seasonal Allergic Rhinitis
Evaluation of the effect of fluticasone propionate vs placebo applied as nasal spray on the increase of allergen-specific serum IgE levels following nasal exposure to recombinant allergens. Nasal sprays will be applied for four weeks starting two weeks before nasal provocation and serum IgE levels will be followed during eight weeks after nasal provocation.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Fluticasone propionate, Placebo
- 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.
Fluticasone propionateDrug
200 µg intranasal, 4 weeks, od.
PlaceboDrug
Placebo intranasal spray
| Study group | Role | What they receive |
|---|---|---|
| F | Experimental | Fluticasone propionate 200 µg intranasal Receives: Drug: Fluticasone propionate |
| P | Placebo comparator | Placebo intranasal spray Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allergen specific IgE levels
Measured: 8 weeks
Secondary outcomes (1)
Allergen specific IgG 1-4, IgM, IgA levels
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Allergy Centre Vienna West
- Investigators
- Friedrich Horak, MD, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755066
- Sponsor's protocol ID
- 2505
- Other IDs
- EudraCT 2005-004274-24
- Status last verified
- Sep 2008
- First submitted
- 17 Sep 2008
- Last updated
- 26 Sep 2008
- Results posted
- No
Publications
Egger C, Lupinek C, Ristl R, Lemell P, Horak F, Zieglmayer P, Spitzauer S, Valenta R, Niederberger V. Effects of nasal corticosteroids on boosts of systemic allergen-specific IgE production induced by nasal allergen exposure. PLoS One. 2015 Feb 23;10(2):e0114991. doi: 10.1371/journal.pone.0114991. eCollection 2015.
PubMed 25705889
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intranasal Corticosteroid on the Immune Response Following Nasal Allergen Challenge in Patients Suffering From Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00755066
- Acronym / sponsor ID
- 2505
- Conditions
- Seasonal Allergic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Allergy Centre Vienna West
- First posted
- 18 Sep 2008 (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.
Evaluation of the effect of fluticasone propionate vs placebo applied as nasal spray on the increase of allergen-specific serum IgE levels following nasal exposure to recombinant allergens. Nasal sprays will be applied for four weeks starting two weeks before nasal provocation and serum IgE levels will be followed during eight weeks after nasal provocation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F | Experimental | Drug: Fluticasone propionateFluticasone propionate 200 µg intranasal |
| P | Placebo comparator | Drug: PlaceboPlacebo intranasal spray |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- male or female 18-50 years of age
- moderate to severe allergic rhinitis to grass and/or birch pollen for at least two seasons according to history
- sensitization to rPhl p 5 and rBet v 1 as demonstrated by UniCAP within a range from 3.0-80 kUA/l and a positive (wheal diameter >= 3 mm larger than the negative control and half of the histamine control) SPT with rPhl p 5 and rBet v 1 at 20 µg/ml
- willingness to comply with the study protocol
- written informed consent
Key exclusion criteria (35 listed)
- perennial allergic rhinitis
- history of asthma necessitating treatment
- FEV1 <70% of predicted value
- abnormalities at auscultation of heart or lungs
- history of anaphylaxis
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 |
|---|---|---|
| Fluticasone propionate200 µg intranasal, 4 weeks, od. | Drug | F |
| PlaceboPlacebo intranasal spray | Drug | P |
Primary outcome
Allergen specific IgE levels
Time frame: 8 weeks
1 secondary outcome
Allergen specific IgG 1-4, IgM, IgA levels
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2008.
- Derived from this study: PubMed 25705889Egger C, Lupinek C, Ristl R, Lemell P, Horak F, Zieglmayer P, Spitzauer S, Valenta R, Niederberger V. Effects of nasal corticosteroids on boosts of systemic allergen-specific IgE production induced by nasal allergen exposure. PLoS One. 2015 Feb 23;10(2):e0114991. doi: 10.1371/journal.pone.0114991. eCollection 2015.
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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.
Friedrich Horak, MD principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluticasone propionate in people with Seasonal Allergic Rhinitis, run by Medical University of Vienna at 1 site in Austria.
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 5 inclusion and 35 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 26 Sep 2008. 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 Austria. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Allergen specific IgE levels (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00755066, which also lists 1 linked publication.
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 26 Sep 2008.