Seasonal Allergic RhinitisPhase 3NCT01400828
Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg in Korean Patients With Seasonal Allergic Rhinitis
A Phase 3 study testing Bilastine and Desloratadine in people with Seasonal Allergic Rhinitis, run by Yuhan Corporation at 1 site in South Korea.
Trial summary
The objective of the study was to determine the efficacy and tolerability of 20 mg of Bilastine, compared to Desloratadine and placebo for the treatment of Seasonal Allergic Rhinitis. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- Bilastine and Desloratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to May 2014
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The study disease was diagnosed on the basis of clinical criteria: Nasal symptoms (presence of nasal blockage, sneezing, nasal itching and rhinorrhea) and non-nasal symptoms (ocular itching, lacrimation, itching of ears and/or palate and ocular redness), as well as the skin prick test performed at the time of selection or within the year prior to entering.
- Patients with history of Seasonal Allergic Rhinitis, positive skin prick test and symptoms were included if they were between 12 and 70 years old, gave their informed consent, attended the required visits scheduled and also underwent a complete medical examination..
Who cannot join
- Patients were excluded if they had a significant nasal abnormality which could interfere with the aim of the study, acute or chronic sinusitis, asthma or any condition, disease or hypersensitivity that could be harmed.
- Patients were not allowed to take forbidden medications or not comply the study requirements.
- Patients who were currently participating in or had participated in another clinical trial within the previous three months or were planning to travel outside of the study area during the course of the study were excluded.
- Pregnant or breast-feeding women were also excluded.
- Women of childbearing potential had a pregnancy test done
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University college of Medicine, Gangnam Severance Hospital
Seoul
About this study
Official title: Randomized, Double-blind, Placebo/Active-controlled, Multi-center Clinical Trial to Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg After 14-day Oral Administration in Patients With Seasonal Allergic Rhinitis
The objective of the study was to determine the efficacy and tolerability of 20 mg of Bilastine, compared to Desloratadine and placebo for the treatment of Seasonal Allergic Rhinitis.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Bilastine, Desloratadine, 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.
BilastineDrug
20 mg (encapsulated) tablets QD/14 days
DesloratadineDrug
Also called Aerius
5 mg (encapsulated) tablets QD/14 days
PlaceboDrug
(encapsulated) Tablets QD/14 days
| Study group | Role | What they receive |
|---|---|---|
| Bilastine | Experimental | Intervention: Drug: Bilastine Receives: Drug: Bilastine |
| Desloratadine | Active comparator | Intervention: Drug: Desloratadine Receives: Drug: Desloratadine |
| Placebo | Placebo comparator | Intervention: Drug: Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of TSS
The area under curve (AUC) of the total symptom score (TSS) since basal visit to D14 visit according to the patient's assessment
Measured: 14 days
Secondary outcomes (9)
Change in TSS. Reflective symptoms
Change in the reflective total score on symptom scale on D14 visit and day7 visit versus D0 visit (baseline) according to the patient´s assessment on the previous 12 hours.
Measured: 14 days
Change in TSS. Instantaneous score
Change in the total score on symptom scale on D7 and D14 visits versus D0 visit (baseline) according to the patient's assessment (instantaneous score).
Measured: 14days
Change in total nasal symptom score (TNSS)
Change in nasal symptom score on symptom scale on D7 and D14 visits versus D0 visit (baseline) according to the patient's and investigator's assessment
Measured: 14 days
•Change in total non-nasal symptom score (TNNSS)
Change in non-nasal symptom score on symptom scale on D7 and D14 visits versus D0 visit (baseline) according to the patient's and investigator's assessment
Measured: 14 days
VAS of discomfort
Overall assessment of discomfort caused by allergic rhinitis using a visual analog scale (VAS) on D7 and D14 versus D0.
Measured: 14 days
CGI
Investigator's overall clinical impression (CGI)
Measured: 14 days
•Allergic rhinitis (AR) quality of life (QoL) questionnaire (RQLQ)
Quality of Life change versus baseline.
Measured: 14 days
responde's rate
Patients were analysed based on their total symptoms score decrease from baseline (<25%, 25%-50%, 50%-75%, >75%).
Measured: 14 days
safety assessment
comparison of the adverse event profiles throughout the course of the study, ECGs and safety blood tests on D0 and D14.
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 posted22 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2013
- Study completionMay 2014
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.
- More trials run by Yuhan CorporationThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuhan Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400828
- Sponsor's protocol ID
- YCD159
- Status last verified
- Jul 2014
- First submitted
- 20 Jul 2011
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo/Active-controlled, Multi-center Clinical Trial to Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg After 14-day Oral Administration in Patients With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01400828
- Acronym / sponsor ID
- YCD159
- Conditions
- Seasonal Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Yuhan CorporationIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 22 Jul 2011 (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 objective of the study was to determine the efficacy and tolerability of 20 mg of Bilastine, compared to Desloratadine and placebo for the treatment of Seasonal Allergic Rhinitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bilastine | Experimental | Drug: BilastineIntervention: Drug: Bilastine |
| Desloratadine | Active comparator | Drug: DesloratadineIntervention: Drug: Desloratadine |
| Placebo | Placebo comparator | Drug: PlaceboIntervention: Drug: Placebo |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- The study disease was diagnosed on the basis of clinical criteria: Nasal symptoms (presence of nasal blockage, sneezing, nasal itching and rhinorrhea) and non-nasal symptoms (ocular itching, lacrimation, itching of ears and/or palate and ocular redness), as well as the skin prick test performed at the time of selection or within the year prior to entering.
- Patients with history of Seasonal Allergic Rhinitis, positive skin prick test and symptoms were included if they were between 12 and 70 years old, gave their informed consent, attended the required visits scheduled and also underwent a complete medical examination..
Key exclusion criteria (5 listed)
- Patients were excluded if they had a significant nasal abnormality which could interfere with the aim of the study, acute or chronic sinusitis, asthma or any condition, disease or hypersensitivity that could be harmed.
- Patients were not allowed to take forbidden medications or not comply the study requirements.
- Patients who were currently participating in or had participated in another clinical trial within the previous three months or were planning to travel outside of the study area during the course of the study were excluded.
- Pregnant or breast-feeding women were also excluded.
- Women of childbearing potential had a pregnancy test done
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 |
|---|---|---|
| Bilastine20 mg (encapsulated) tablets QD/14 days | Drug | Bilastine |
| DesloratadineAlso: Aerius5 mg (encapsulated) tablets QD/14 days | Drug | Desloratadine |
| Placebo(encapsulated) Tablets QD/14 days | Drug | Placebo |
Primary outcome
AUC of TSS
Time frame: 14 days
The area under curve (AUC) of the total symptom score (TSS) since basal visit to D14 visit according to the patient's assessment
9 secondary outcomes
Change in TSS. Reflective symptoms
Time frame: 14 days
Change in TSS. Instantaneous score
Time frame: 14days
Change in total nasal symptom score (TNSS)
Time frame: 14 days
•Change in total non-nasal symptom score (TNNSS)
Time frame: 14 days
VAS of discomfort
Time frame: 14 days
CGI
Time frame: 14 days
•Allergic rhinitis (AR) quality of life (QoL) questionnaire (RQLQ)
Time frame: 14 days
responde's rate
Time frame: 14 days
safety assessment
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 10 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bilastine and Desloratadine in people with Seasonal Allergic Rhinitis, run by Yuhan Corporation at 1 site in South Korea.
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 10 Jul 2014. 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 South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
AUC of TSS (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 10 Jul 2014.