Seasonal Allergic RhinitisPhase 2NCT00574379
Efficacy, Safety and PK of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo in the Symptomatic Treatment of SAR
A Phase 2 study testing Bilastine in people with Seasonal Allergic Rhinitis and Hay Fever, run by Faes Farma, S.A. at 13 sites in United States.
Trial summary
Evaluate the relative efficacy of four dosing regimens of bilastine tablets (given either once or twice per day) versus placebo in patients with Seasonal Allergic Rhinitis (SAR) in the Mountain Cedar season in south Texas and Oklahoma based on the mean change from baseline in Reflective Total Nasal Symptom Scores… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Seasonal Allergic Rhinitis, Hay Fever, Allergic Conjunctivitis
- 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
- 805 participants
- Where
- 13 sitesUnited States
- Study dates
- Dec 2007to Mar 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- clinical history of Seasonal Allergic Rhinoconjunctivitis with seasonal onset and offset of nasal allergy symptoms
- documentation of a positive skin test within one year of screening to Mountain Cedar allergen
Who cannot join
- significant medical condition
- significant nasal abnormality
- significant cardiac condition
- recent infection
- use of other allergy medication during the study
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
MetaClin Research Inc.
Austin, Texas, 78704
Austin Clinical Research
Austin, Texas, 78750
Lovelace Scientific Resources
Austin, Texas, 78759
Kerrville Research Associates
Kerrville, Texas, 78028-6071
Oklahoma Allergy and Asthma Clinic
Oklahoma City, Oklahoma, 73104
Biogenics Research Institute
San Antonio, Texas, 78229
DGD Research
San Antonio, Texas, 78229
Diagnostics Research Group
San Antonio, Texas, 78229
Southwest Allergy and Asthma Centre
San Antonio, Texas, 78229
Sylvana Research Associates
San Antonio, Texas, 78229
Live Oak Allergy and Asthma
San Antonio, Texas, 78233
Allergy & Asthma Care of Waco
Waco, Texas, 76708
Allergy Asthma Research Institute
Waco, Texas, 76712
About this study
Official title: A Multi-Center Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo Given Orally in The Treatment of the Symptoms of Seasonal Allergic Rhino-Conjunctivitis With Allergy to Mountain Cedar Pollen
Evaluate the relative efficacy of four dosing regimens of bilastine tablets (given either once or twice per day) versus placebo in patients with Seasonal Allergic Rhinitis (SAR) in the Mountain Cedar season in south Texas and Oklahoma based on the mean change from baseline in Reflective Total Nasal Symptom Scores (TNSS) assessed over 14 days of treatment.
- Being tested
- Bilastine, Placebo
- Keywords
- Allergic Rhinitis, Mountain Cedar Pollen, Pollen Allergy, Rhinoconjunctivitis
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Conjunctivitis, Allergic, Hypersensitivity, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BilastineDrug
Bilastine 10 or 20mg, once or twice daily for 14 days. Tablets
PlaceboDrug
Placebo tablets twice daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bilastine 20mg once per day Receives: Drug: Bilastine |
| 2 | Experimental | Bilastine 20mg twice per day Receives: Drug: Bilastine |
| 3 | Experimental | Bilastine 10mg once per day Receives: Drug: Bilastine |
| 4 | Experimental | Bilastine 10mg twice per day Receives: Drug: Bilastine |
| 5 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nasal symptom scores
Measured: 14 days
Secondary outcomes (1)
Change in ocular symptom scores and quality of life scores; standard safety assessments
Measured: 14 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 startDec 2007
- Primary completionMar 2008
- Study completionMar 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
- 805 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faes Farma, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC, Allied Research International
- Responsible party
- Sponsor
- Investigators
- Ander Sologuren, MD, Study director, Faes Farma, S.A.Paul Ratner, MD, Principal investigator, Sylvana Research Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00574379
- Sponsor's protocol ID
- BILA 2607/RAE
- Other IDs
- CTFZ07001
- Status last verified
- Feb 2019
- First submitted
- 14 Dec 2007
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
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 Multi-Center Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo Given Orally in The Treatment of the Symptoms of Seasonal Allergic Rhino-Conjunctivitis With Allergy to Mountain Cedar Pollen
- ClinicalTrials.gov ID
- NCT00574379
- Acronym / sponsor ID
- BILA 2607/RAE
- Keywords
- Allergic Rhinitis, Mountain Cedar Pollen, Pollen Allergy, Rhinoconjunctivitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 805 participants (actual)
- Lead sponsor
- Faes Farma, S.A.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC, Allied Research International
- Study start
- Dec 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 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.
Evaluate the relative efficacy of four dosing regimens of bilastine tablets (given either once or twice per day) versus placebo in patients with Seasonal Allergic Rhinitis (SAR) in the Mountain Cedar season in south Texas and Oklahoma based on the mean change from baseline in Reflective Total Nasal Symptom Scores (TNSS) assessed over 14 days of treatment.
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 20mg once per day |
| 2 | Experimental | Drug: BilastineBilastine 20mg twice per day |
| 3 | Experimental | Drug: BilastineBilastine 10mg once per day |
| 4 | Experimental | Drug: BilastineBilastine 10mg twice per day |
| 5 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- clinical history of Seasonal Allergic Rhinoconjunctivitis with seasonal onset and offset of nasal allergy symptoms
- documentation of a positive skin test within one year of screening to Mountain Cedar allergen
Key exclusion criteria (5 listed)
- significant medical condition
- significant nasal abnormality
- significant cardiac condition
- recent infection
- use of other allergy medication during the study
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 10 or 20mg, once or twice daily for 14 days. Tablets | Drug | 1, 2, 3, 4 |
| PlaceboPlacebo tablets twice daily for 14 days | Drug | 5 |
Primary outcome
Change in nasal symptom scores
Time frame: 14 days
1 secondary outcome
Change in ocular symptom scores and quality of life scores; standard safety assessments
Time frame: 14 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.
Ander Sologuren, MD study director
Faes Farma, S.A.
Paul Ratner, MD principal investigator
Sylvana Research Associates
13 sites 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 13 sites 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 2 inclusion and 5 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 13 sites 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 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?
Change in nasal symptom scores (time frame: 14 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.