Seasonal Allergic RhinitisPhase 2NCT00420082
A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber
A Phase 2 study testing Bilastine, Fexofenadine and Cetirizine in people with Seasonal Allergic Rhinitis, run by Faes Farma, S.A. at 1 site in Austria.
Trial summary
This is a randomized, double blind, active and placebo controlled, 4 way crossover study in patients with seasonal allergic rhinitis. Patients will receive a single dose of bilastine 20 mg, Cetirizine 10 mg, Fexofenadine 120 mg, and placebo in the Vienna Challenge Chamber. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Bilastine, Fexofenadine and Cetirizine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2006to Dec 2006
- Phase
- Phase 2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Have a history of seasonal allergic rhinitis
- Have a positive (as defined in the protocol) skin prick or RAST test within 12 months prior to the screening visit
Who cannot join
- Have a clinically significant illness or disease
- Have unstable asthma
- Has participated in a clinical trial 30 days prior to the screening visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, 4 Way Cross-over, Placebo Controlled Trial to Evaluate the Onset of Action of Bilastine 20 mg vs. Placebo, Cetirizine 10 mg, and Fexofenadine 120 mg in the Vienna Challenge Chamber
This is a randomized, double blind, active and placebo controlled, 4 way crossover study in patients with seasonal allergic rhinitis. Patients will receive a single dose of bilastine 20 mg, Cetirizine 10 mg, Fexofenadine 120 mg, and placebo in the Vienna Challenge Chamber.
Read the detailed description
The objective of the study is to determine the effect of a single dose of bilastine 20 mg on nasal symptoms of allergic rhinitis provoked by spending 4 hours in the Vienna Challenge Chamber . This effect will be compared to that action of Cetirizine 10 mg, Fexofenadine 120 mg, and placebo. To explore the onset of action, patients will receive study drug two hours after the start of the provocation on Day 1.Patients will remain in theVCC for an additional four hours. On Day 2, patients will return to the VCC post-dose hours 22-26.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Bilastine, Fexofenadine, Cetirizine, Placebo
- Keywords
- Rhinitis, Seasonal, Allergic, Pollen allergy, Environmental Exposure Chamber, Challenge Chamber
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BilastineDrug
Encapsulated Bilastine 20 mg tablets Q.D.
FexofenadineDrug
Also called Allegra
Encapsulated Fexofenadine 120 mg tablets Q.D.
CetirizineDrug
Also called Zyrtec
Encapsulated Cetirizine 10 mg tablets Q.D.
PlaceboDrug
Encapsulated Placebo tablets Q.D.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bilastine 20 mg Receives: Drug: Bilastine |
| 2 | Active comparator | Fexofenadine 120 mg Receives: Drug: Fexofenadine |
| 3 | Active comparator | Cetirizine 10 mg Receives: Drug: Cetirizine |
| 4 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Onset of action and action duration
Secondary outcomes (5)
Nasal and ocular symptom scores
Nasal airflow resistance
Nasal secretion weight
FEV1
Routine safety parameters (vital signs, ECGs, clinical laboratory tests)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2007 (estimated)
- Study startOct 2006
- Study completionDec 2006
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faes Farma, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Friedrich Horak, Professor, Principal investigator, ENT University Clinic Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00420082
- Sponsor's protocol ID
- BILA-2306/ACC
- Other IDs
- 2006-003004-19
- Status last verified
- Apr 2012
- First submitted
- 8 Jan 2007
- Last updated
- 5 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Horak F, Zieglmayer P, Zieglmayer R, Lemell P. The effects of bilastine compared with cetirizine, fexofenadine, and placebo on allergen-induced nasal and ocular symptoms in patients exposed to aeroallergen in the Vienna Challenge Chamber. Inflamm Res. 2010 May;59(5):391-8. doi: 10.1007/s00011-009-0117-4. Epub 2009 Nov 27.
PubMed 19943178
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, 4 Way Cross-over, Placebo Controlled Trial to Evaluate the Onset of Action of Bilastine 20 mg vs. Placebo, Cetirizine 10 mg, and Fexofenadine 120 mg in the Vienna Challenge Chamber
- ClinicalTrials.gov ID
- NCT00420082
- Acronym / sponsor ID
- BILA-2306/ACC
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Rhinitis, Seasonal, Allergic, Pollen allergy, Environmental Exposure Chamber, Challenge Chamber
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Faes Farma, S.A.Industry (pharma, biotech, devices)
- Study start
- Oct 2006
- Study completion
- Dec 2006 (actual)
- First posted
- 9 Jan 2007 (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.
This is a randomized, double blind, active and placebo controlled, 4 way crossover study in patients with seasonal allergic rhinitis. Patients will receive a single dose of bilastine 20 mg, Cetirizine 10 mg, Fexofenadine 120 mg, and placebo in the Vienna Challenge Chamber.
Detailed description
The objective of the study is to determine the effect of a single dose of bilastine 20 mg on nasal symptoms of allergic rhinitis provoked by spending 4 hours in the Vienna Challenge Chamber . This effect will be compared to that action of Cetirizine 10 mg, Fexofenadine 120 mg, and placebo. To explore the onset of action, patients will receive study drug two hours after the start of the provocation on Day 1.Patients will remain in theVCC for an additional four hours. On Day 2, patients will return to the VCC post-dose hours 22-26.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BilastineBilastine 20 mg |
| 2 | Active comparator | Drug: FexofenadineFexofenadine 120 mg |
| 3 | Active comparator | Drug: CetirizineCetirizine 10 mg |
| 4 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Have a history of seasonal allergic rhinitis
- Have a positive (as defined in the protocol) skin prick or RAST test within 12 months prior to the screening visit
Key exclusion criteria (3 listed)
- Have a clinically significant illness or disease
- Have unstable asthma
- Has participated in a clinical trial 30 days prior to the screening visit
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 |
|---|---|---|
| BilastineEncapsulated Bilastine 20 mg tablets Q.D. | Drug | 1 |
| FexofenadineAlso: AllegraEncapsulated Fexofenadine 120 mg tablets Q.D. | Drug | 2 |
| CetirizineAlso: ZyrtecEncapsulated Cetirizine 10 mg tablets Q.D. | Drug | 3 |
| PlaceboEncapsulated Placebo tablets Q.D. | Drug | 4 |
Primary outcome
Onset of action and action duration
5 secondary outcomes
Nasal and ocular symptom scores
Nasal airflow resistance
Nasal secretion weight
FEV1
Routine safety parameters (vital signs, ECGs, clinical laboratory tests)
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 5 Apr 2012.
- Results publication: PubMed 19943178Horak F, Zieglmayer P, Zieglmayer R, Lemell P. The effects of bilastine compared with cetirizine, fexofenadine, and placebo on allergen-induced nasal and ocular symptoms in patients exposed to aeroallergen in the Vienna Challenge Chamber. Inflamm Res. 2010 May;59(5):391-8. doi: 10.1007/s00011-009-0117-4. Epub 2009 Nov 27.
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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, Professor principal investigator
ENT University Clinic Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bilastine, Fexofenadine and Cetirizine in people with Seasonal Allergic Rhinitis, run by Faes Farma, S.A. 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 2 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 5 Apr 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Onset of action and action duration. 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 NCT00420082, 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 5 Apr 2012.