Seasonal Allergic RhinitisPhase 2NCT00574210
PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm)
A Phase 2 study testing Bilastine in people with Seasonal Allergic Rhinitis and Hay Fever, run by Faes Farma, S.A. at 1 site in Canada.
Trial summary
The purpose of this study is to evaluate the relative efficacy of four dosing regimens of bilastine tablets versus placebo in subjects with SAR exposed in controlled ragweed pollen using the EEC model based on the mean change from baseline in Total Nasal Symptom Scores (TNSS). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Seasonal Allergic Rhinitis, Hay Fever, Rhinoconjunctivitis
- What is being tested?
- Bilastine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 502 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2007to Feb 2008
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical history of SAR for the last two ragweed allergy seasons.
- A positive skin test within 12 months of screening to ragweed allergen.
- A minimum qualifying symptom score on both Visits, 2 and 3.
- Females must have a confirmed absence of pregnancy according to a negative urine pregnancy test.
Who cannot join
- Women who are pregnant, breastfeeding, or planning a pregnancy.
- History of more than mild asthma.
- History of clinically significant (as determined by the Investigator) active perennial allergic rhinitis to which the subject is regularly exposed.
- Non-allergic rhinitis (vasomotor or rhinitis medicamentosa).
- An anatomic abnormality that interferes with assessment of nasal function. - History of clinically significant recurrent sinusitis or chronic sinusitis. - Clinically significant (as determined by the Investigator) cardiovascular, hepatic, neurologic, psychiatric, endocrine, or other significant systemic disease that makes implementation of the protocol jeopardizing to the safety of the subject.
- A need for use of antihistamines or corticosteroids on a regular basis (systemic or topical).
Show all 12Show fewer
- Currently taking monoamine oxidase (MAO) inhibitors.
- Taken any systemic corticosteroids, immunomodulators, or immune suppressive medications within four weeks prior to Visit 1.
- Taken any antihistamine within seven days prior to Visit 1 skin testing.
- Known current alcohol or drug abuse.
- Current participation in another clinical study involving an experimental treatment, or participation in such a study within 30 days prior to study entry. - History of generalized anaphylaxis requiring medical attention.
- Clinically significant abnormality of screening blood chemistry, hematology, or urinalysis.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Allied Research International - Cetero Research
Mississauga, Ontario, 905-238-0599
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, 5-arm Parallel Study to Evaluate the Pharmacokinetics/ Pharmacodynamics and Steady State Efficacy of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo Given Orally in the Treatment of the Symptoms of Seasonal Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Mode
The purpose of this study is to evaluate the relative efficacy of four dosing regimens of bilastine tablets versus placebo in subjects with SAR exposed in controlled ragweed pollen using the EEC model based on the mean change from baseline in Total Nasal Symptom Scores (TNSS). Study includes male and female subjects, aged 18 and 65 years with clinical history of SAR with seasonal onset and offset of nasal allergy symptoms during each of the last two ragweed allergy seasons and a positive skin prick test to ragweed allergen within 12 months prior to randomization.
- Conditions
- Seasonal Allergic Rhinitis, Hay Fever, Rhinoconjunctivitis
- Being tested
- Bilastine, Placebo
- Keywords
- Seasonal Allergic Rhinitis (SAR), Environmental Exposure Chamber (EEC), Therapeutic Uses, Antihistamine Drug, Ragweed Pollen
- 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.
BilastineDrug
Bilastine Tablets, administered at a dosage strength of 10 mg or 20 mg, once or twice per day.
PlaceboDrug
Placebo Tablets administered twice per day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bilastine oral 20 mg once per day (1 x 20 mg bilastine tablet plus 1 placebo tablet) Receives: Drug: Bilastine |
| 2 | Experimental | Bilastine oral 20 mg twice per day (2 x 20 mg bilastine tablets) Receives: Drug: Bilastine |
| 3 | Experimental | Bilastine oral 10 mg once per day (1 x 10 mg bilastine tablet plus 1 placebo tablet) Receives: Drug: Bilastine |
| 4 | Experimental | Bilastine oral 10 mg twice per day (2 x 10 mg bilastine tablets) Receives: Drug: Bilastine |
| 5 | Placebo comparator | Placebo oral twice per day (2 placebo tablets) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Scores (TNSS)
Measured: within 10 days
Secondary outcomes (1)
Total Symptom Scores (TSS), Total Non-Nasal Symptom Scores (TNNSS), Total Ocular Symptoms Scores (TOSS), Area Under the Curve (AUC) of TNSS, TSS, TOSS, TNNSS, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ - EEC)
Measured: witin 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faes Farma, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Allied Research International
- Responsible party
- Sponsor
- Investigators
- Roman Valiente, MD, Study chair, Faes Farma, S.A.Piyush Patel, MD, Study director, Allied Research International IncDeepen Patel, MD, CCFP, Principal investigator, Allied Research International Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574210
- Sponsor's protocol ID
- BILA 2507/EEC
- Other IDs
- P2FZ07001
- Status last verified
- Feb 2019
- First submitted
- 14 Dec 2007
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, 5-arm Parallel Study to Evaluate the Pharmacokinetics/ Pharmacodynamics and Steady State Efficacy of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo Given Orally in the Treatment of the Symptoms of Seasonal Allergic Rhinitis in an Environmental Exposure Chamber (EEC) Mode
- ClinicalTrials.gov ID
- NCT00574210
- Acronym / sponsor ID
- BILA 2507/EEC
- Conditions
- Seasonal Allergic Rhinitis, Hay Fever, Rhinoconjunctivitis
- Keywords
- Seasonal Allergic Rhinitis (SAR), Environmental Exposure Chamber (EEC), Therapeutic Uses, Antihistamine Drug, Ragweed Pollen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- Faes Farma, S.A.Industry (pharma, biotech, devices)
- Collaborators
- Allied Research International
- Study start
- Oct 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 17 Dec 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.
The purpose of this study is to evaluate the relative efficacy of four dosing regimens of bilastine tablets versus placebo in subjects with SAR exposed in controlled ragweed pollen using the EEC model based on the mean change from baseline in Total Nasal Symptom Scores (TNSS). Study includes male and female subjects, aged 18 and 65 years with clinical history of SAR with seasonal onset and offset of nasal allergy symptoms during each of the last two ragweed allergy seasons and a positive skin prick test to ragweed allergen within 12 months prior to randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BilastineBilastine oral 20 mg once per day (1 x 20 mg bilastine tablet plus 1 placebo tablet) |
| 2 | Experimental | Drug: BilastineBilastine oral 20 mg twice per day (2 x 20 mg bilastine tablets) |
| 3 | Experimental | Drug: BilastineBilastine oral 10 mg once per day (1 x 10 mg bilastine tablet plus 1 placebo tablet) |
| 4 | Experimental | Drug: BilastineBilastine oral 10 mg twice per day (2 x 10 mg bilastine tablets) |
| 5 | Placebo comparator | Drug: PlaceboPlacebo oral twice per day (2 placebo tablets) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical history of SAR for the last two ragweed allergy seasons.
- A positive skin test within 12 months of screening to ragweed allergen.
- A minimum qualifying symptom score on both Visits, 2 and 3.
- Females must have a confirmed absence of pregnancy according to a negative urine pregnancy test.
Key exclusion criteria (12 listed)
- Women who are pregnant, breastfeeding, or planning a pregnancy.
- History of more than mild asthma.
- History of clinically significant (as determined by the Investigator) active perennial allergic rhinitis to which the subject is regularly exposed.
- Non-allergic rhinitis (vasomotor or rhinitis medicamentosa).
- An anatomic abnormality that interferes with assessment of nasal function. - History of clinically significant recurrent sinusitis or chronic sinusitis. - Clinically significant (as determined by the Investigator) cardiovascular, hepatic, neurologic, psychiatric, endocrine, or other significant systemic disease that makes implementation of the protocol jeopardizing to the safety of the subject.
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 |
|---|---|---|
| BilastineBilastine Tablets, administered at a dosage strength of 10 mg or 20 mg, once or twice per day. | Drug | 1, 2, 3, 4 |
| PlaceboPlacebo Tablets administered twice per day | Drug | 5 |
Primary outcome
Total Nasal Symptom Scores (TNSS)
Time frame: within 10 days
1 secondary outcome
Total Symptom Scores (TSS), Total Non-Nasal Symptom Scores (TNNSS), Total Ocular Symptoms Scores (TOSS), Area Under the Curve (AUC) of TNSS, TSS, TOSS, TNNSS, Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ - EEC)
Time frame: witin 10 days
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 15 Feb 2019.
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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.
Roman Valiente, MD study chair
Faes Farma, S.A.
Piyush Patel, MD study director
Allied Research International Inc
Deepen Patel, MD, CCFP principal investigator
Allied Research International Inc
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 in people with Seasonal Allergic Rhinitis and Hay Fever, run by Faes Farma, S.A. at 1 site in Canada.
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 12 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 15 Feb 2019. 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 Canada. 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?
Total Nasal Symptom Scores (TNSS) (time frame: within 10 days). 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 15 Feb 2019.