Allergic RhinitisPhase 4NCT01657097
Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge
A Phase 4 study testing INCS in people with Allergic Rhinitis and Asthma, run by University of Aarhus at 1 site in Denmark.
Trial summary
Allergic rhinitis is a common condition caused by inflammation of nasal mucosa. The study was performed to gain information on this inflammation, including effect of intranasal corticosteroid treatment hereupon and potential influence on the lower airways, ie asthma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinitis, Asthma
- What is being tested?
- INCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 1997to Apr 1997
- Phase
- Phase 4
- 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
- monoallergy to grass
- symptoms of allergic rhinitis for at least the two most recent grasspollen seasons
- asthma symptoms of asthma for at least two of the four most recent grasspollen seasons
- age 18 or older
Who cannot join
- pregnancy or lactation
- fertile women, not sterilised or using sufficient anticonception
- Corticosteroid treatment (parenteral, oral, inhaled or intranasal) within two months prior to enrolment
- Any other disease, condition or treatment, which to the discretion of the investigator has the potential to interfere with study results
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Respiratory Diseases, Aarhus University Hospital
Aarhus, DK-8000 C
About this study
Official title: Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge. Impact on Bronchial Hyperresponsiveness and the Effect of Intranasal Corticosteroid Treatment
Allergic rhinitis is a common condition caused by inflammation of nasal mucosa. The study was performed to gain information on this inflammation, including effect of intranasal corticosteroid treatment hereupon and potential influence on the lower airways, ie asthma.
The study was randomised, placebo-controlled double-blind in patients, monoallergic to grasspollen, presenting symptoms of rhinitis and asthma during season.
Treatment,ie intranasal corticosteroid or placebo, were given four weeks. After two weeks of treatment intranasal allergen challenge was performed. Measurements were performed during the full study period.
The study was performed out of pollen season.
- Conditions
- Allergic Rhinitis, Asthma
- Being tested
- INCS, Placebo
- Medical subject headings
- Rhinitis, Allergic, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCSDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| INCS | Experimental | Fluticasone propionate 400 microgram daily Receives: Drug: INCS |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Eosinophil Cationic Protein (ECP)
Measured: 1 month
Secondary outcomes (4)
Serum Eosinophil Peroxidase (EPO)
Measured: 1 month
Nasal lavage Eosinophil Cationic Protein (ECP)
Measured: 1 month
Nasal lavage Eosinophil Peroxidase (EPO)
Measured: 1 month
Blood Eosinophils
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startFeb 1997
- Primary completionApr 1997
- Study completionApr 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Ronald Dahl, MD, Principal investigator, Department of Respiratory Diseases, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657097
- Sponsor's protocol ID
- RHINO97
- Status last verified
- Aug 2012
- First submitted
- 1 Aug 2012
- Last updated
- 6 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge. Impact on Bronchial Hyperresponsiveness and the Effect of Intranasal Corticosteroid Treatment
- ClinicalTrials.gov ID
- NCT01657097
- Acronym / sponsor ID
- RHINO97
- Conditions
- Allergic Rhinitis, Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Feb 1997
- Primary completion
- Apr 1997 (actual)
- Study completion
- Apr 1997 (actual)
- First posted
- 3 Aug 2012 (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.
Allergic rhinitis is a common condition caused by inflammation of nasal mucosa. The study was performed to gain information on this inflammation, including effect of intranasal corticosteroid treatment hereupon and potential influence on the lower airways, ie asthma.
The study was randomised, placebo-controlled double-blind in patients, monoallergic to grasspollen, presenting symptoms of rhinitis and asthma during season.
Treatment,ie intranasal corticosteroid or placebo, were given four weeks. After two weeks of treatment intranasal allergen challenge was performed. Measurements were performed during the full study period.
The study was performed out of pollen season.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| INCS | Experimental | Drug: INCSFluticasone propionate 400 microgram daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- monoallergy to grass
- symptoms of allergic rhinitis for at least the two most recent grasspollen seasons
- asthma symptoms of asthma for at least two of the four most recent grasspollen seasons
- age 18 or older
Key exclusion criteria (4 listed)
- pregnancy or lactation
- fertile women, not sterilised or using sufficient anticonception
- Corticosteroid treatment (parenteral, oral, inhaled or intranasal) within two months prior to enrolment
- Any other disease, condition or treatment, which to the discretion of the investigator has the potential to interfere with study results
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 |
|---|---|---|
| INCS | Drug | INCS |
| Placebo | Drug | Placebo |
Primary outcome
Serum Eosinophil Cationic Protein (ECP)
Time frame: 1 month
4 secondary outcomes
Serum Eosinophil Peroxidase (EPO)
Time frame: 1 month
Nasal lavage Eosinophil Cationic Protein (ECP)
Time frame: 1 month
Nasal lavage Eosinophil Peroxidase (EPO)
Time frame: 1 month
Blood Eosinophils
Time frame: 1 month
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 6 Aug 2012.
Related trials for Allergic Rhinitis
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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.
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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.
Ronald Dahl, MD principal investigator
Department of Respiratory Diseases, Aarhus University Hospital
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 INCS in people with Allergic Rhinitis and Asthma, run by University of Aarhus at 1 site in Denmark.
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 4 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 6 Aug 2012. 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 Denmark. 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?
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?
Serum Eosinophil Cationic Protein (ECP) (time frame: 1 month). 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 6 Aug 2012.