Seasonal Allergic RhinitisPhase 3NCT01108783
A Phase III Efficacy Study of the Symptomatic Treatment of Seasonal Allergic Rhinitis With Bilastine
A Phase 3 study testing Bilastine and Desloratadine in people with Seasonal Allergic Rhinitis, run by Faes Farma, S.A..
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
- 720 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Feb 2004
- 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
About this study
Official title: Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Desloratadine 5 mg for the Treatment of 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.
Read the detailed description
Pivotal, double-blind, randomized, placebo-controlled, comparative with desloratadine, parallel group, international, multicenter study.The Primary endpoint was the Change in total reflective score on the scale of symptoms associated with seasonal allergic rhinitis indicated by patients at the baseline assessment and over the 2 weeks of the study. A total of 720 patients with seasonal allergic rhinitis were enrolled. Duration of treatment was 14 days, preceded by one week (7 days) of placebo.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- Bilastine, Desloratadine, Placebo
- Keywords
- Rhinitis, Allergic, Seasonal, Hay Fever, Pollen Allergy, Pollinosis, Rhinoconjunctivitis, Sneezing, Nasal itching, Nasal Congestion, Rhinorrhea, Ocular itching, Ocular redness, Tearing
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Sneezing, Nasal Obstruction, Rhinorrhea, Lacerations
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 | Not described Receives: Drug: Bilastine |
| Desloratadine | Active comparator | Not described Receives: Drug: Desloratadine |
| Placebo | Placebo comparator | Not described 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: 14 days
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
Quality of Life change versus baseline.
Measured: 14 days
Onset of action
Symptoms assessment in the first 48 hours since the beginning of the treatment
Measured: 2 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 Apr 2010 (estimated)
- Study startApr 2003
- Primary completionAug 2003
- Study completionFeb 2004
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 720 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faes Farma, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Piotr Kuna, Prof. Dr., Principal investigator, Barlicki University Hospital, Medical University of Lodz (Poland)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108783
- Sponsor's protocol ID
- BILA 1003/RAE
- Status last verified
- Apr 2012
- First submitted
- 21 Apr 2010
- Last updated
- 5 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bachert C, Kuna P, Sanquer F, Ivan P, Dimitrov V, Gorina MM, van de Heyning P, Loureiro A; Bilastine International Working Group. Comparison of the efficacy and safety of bilastine 20 mg vs desloratadine 5 mg in seasonal allergic rhinitis patients. Allergy. 2009 Jan;64(1):158-65. doi: 10.1111/j.1398-9995.2008.01813.x.
PubMed 19132976
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
- Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Desloratadine 5 mg for the Treatment of Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01108783
- Acronym / sponsor ID
- BILA 1003/RAE
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Rhinitis, Allergic, Seasonal, Hay Fever, Pollen Allergy, Pollinosis, Rhinoconjunctivitis, Sneezing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 720 participants (actual)
- Lead sponsor
- Faes Farma, S.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2003
- Primary completion
- Aug 2003 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 22 Apr 2010 (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.
Detailed description
Pivotal, double-blind, randomized, placebo-controlled, comparative with desloratadine, parallel group, international, multicenter study.The Primary endpoint was the Change in total reflective score on the scale of symptoms associated with seasonal allergic rhinitis indicated by patients at the baseline assessment and over the 2 weeks of the study. A total of 720 patients with seasonal allergic rhinitis were enrolled. Duration of treatment was 14 days, preceded by one week (7 days) of placebo.
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: Bilastine |
| Desloratadine | Active comparator | Drug: Desloratadine |
| Placebo | Placebo comparator | 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: 14 days
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
Time frame: 14 days
Onset of action
Time frame: 2 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 5 Apr 2012.
- Results publication: PubMed 19132976Bachert C, Kuna P, Sanquer F, Ivan P, Dimitrov V, Gorina MM, van de Heyning P, Loureiro A; Bilastine International Working Group. Comparison of the efficacy and safety of bilastine 20 mg vs desloratadine 5 mg in seasonal allergic rhinitis patients. Allergy. 2009 Jan;64(1):158-65. doi: 10.1111/j.1398-9995.2008.01813.x.
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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.
Piotr Kuna, Prof. Dr. principal investigator
Barlicki University Hospital, Medical University of Lodz (Poland)
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 Faes Farma, S.A..
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 5 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
On the ClinicalTrials.gov record for NCT01108783, 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.