Allergic RhinitisPhase 4QolRhinitisNCT02513290
Quality of Life in Patients With Allergic Rhinitis: Clinical Trial With Bilastine or Loratadine
A Phase 4 study testing Bilastine and Loratadine in people with Allergic Rhinitis, run by Universidade do Sul de Santa Catarina.
Trial summary
The purpose of this study was to verify whether there were differences in health-related quality of life of patients with allergic rhinitis treated with bilastine 20 mg compared to those treated with loratadine 10 mg. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Bilastine and Loratadine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Aug 2014
- Phase
- Phase 4
- 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 diagnosis of allergic rhinitis (a typical history of rhinitis symptoms: coryza, sneezing, nasal obstruction, nasal itching, and eye symptoms, and hypersensitivity tests for specific IgE measured by Radioallergosorbent Test (RAST) or skin tests
- patients classified as with intermittent rhinitis (symptoms during less than 4 days per week) or persistent rhinitis (symptoms during more than 4 days per week) of moderate to severe intensity (annoyance impairing the quality and quantity of sleep and interfering with daily activities)
Who cannot join
- pregnancy or breast-feeding;
- non-allergic rhinitis (vasomotor, infectious or drug-induced);
- known hypersensitivity to antihistamines;
- clinical disorders that might affect the assessment;
- nasal diseases that could lead to complete blockage or one of the nostrils blockage, such as tumors or septal deviation;
- therapy with immunotherapy;
Show all 10Show fewer
- use of antihistamines or disodium cromoglycate within the past four weeks;
- use of topical or systemic corticosteroids, immunosuppressants or any investigational drug within the last two weeks;
- use of topical antihistamines or nasal decongestants within the last 48 hours;
- use of deposit steroid within the last month.
About this study
Official title: Quality of Life in Patients With Allergic Rhinitis: a Clinical Trial Comparing the Use of Bilastine Versus Loratadine
The purpose of this study was to verify whether there were differences in health-related quality of life of patients with allergic rhinitis treated with bilastine 20 mg compared to those treated with loratadine 10 mg.
Read the detailed description
This was a prospective randomized double-blinded study, in which patients were recruited from august 2013 until august 2014. Outpatients attended in 4 otolaryngology clinics from Criciúma, state of Santa Catarina, Brazil were invited to participate of the study. They were aged between 18 and 63 years. Seventy-three patient were included, of whom 36 were treated with loratadine 10 mg and 37 with bilastine 20 mg with medication administered once a day for ten days. The primary outcome was quality of life, assessed by the modified Rhinoconjunctivitis Quality of Life Questionnaire (RQLQm), which was applied at baseline and after 10 days of treatment.
- Conditions
- Allergic Rhinitis
- Being tested
- Bilastine, Loratadine
- Keywords
- quality of life, allergic rhinitis, bilastine, loratadine, clinical trial
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BilastineDrug
Also called Alektos
LoratadineDrug
Also called Claritin, Histadin, Loranil, Loritil
| Study group | Role | What they receive |
|---|---|---|
| Bilastine group | Experimental | Bilastine 20 mg administered once a day for ten days. Receives: Drug: Bilastine |
| Loratadine group | Experimental | Loratadine 10 mg administered once a day for ten days. Receives: Drug: Loratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life in patients with allergic rhinitis
Application of the modified Rhinoconjunctivitis Quality of Life Questionnaire (RQLQm)
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2015 (estimated)
- Study startAug 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Sul de Santa Catarina
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jane da Silva, Universidade do Sul de Santa Catarina
- Investigators
- Jane da Silva, PhD, Principal investigator, Universidade do Sul de Santa Catarina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02513290
- Sponsor's protocol ID
- CTBixLo
- Acronym
- QolRhinitis
- Status last verified
- May 2018
- First submitted
- 29 Jul 2015
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Juniper EF, Thompson AK, Ferrie PJ, Roberts JN. Validation of the standardized version of the Rhinoconjunctivitis Quality of Life Questionnaire. J Allergy Clin Immunol. 1999 Aug;104(2 Pt 1):364-9. doi: 10.1016/s0091-6749(99)70380-5.
PubMed 10452758Carter NJ. Bilastine: in allergic rhinitis and urticaria. Drugs. 2012 Jun 18;72(9):1257-69. doi: 10.2165/11209310-000000000-00000.
PubMed 22686617Nascimento Silva M, Naspitz C, Sole D. Evaluation of quality of life in children and teenagers with allergic rhinitis: adaptation and validation of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Allergol Immunopathol (Madr). 2001 Jul-Aug;29(4):111-8. doi: 10.1016/s0301-0546(01)79042-8.
PubMed 11674923Bachert 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 19132976Van Cauwenberge P, Juniper EF. Comparison of the efficacy, safety and quality of life provided by fexofenadine hydrochloride 120 mg, loratadine 10 mg and placebo administered once daily for the treatment of seasonal allergic rhinitis. Clin Exp Allergy. 2000 Jun;30(6):891-9. doi: 10.1046/j.1365-2222.2000.00914.x.
PubMed 10848909
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Patients With Allergic Rhinitis: a Clinical Trial Comparing the Use of Bilastine Versus Loratadine
- ClinicalTrials.gov ID
- NCT02513290
- Acronym / sponsor ID
- QolRhinitis / CTBixLo
- Conditions
- Allergic Rhinitis
- Keywords
- quality of life, allergic rhinitis, bilastine, loratadine, clinical trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Universidade do Sul de Santa CatarinaOther government
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 31 Jul 2015 (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 was to verify whether there were differences in health-related quality of life of patients with allergic rhinitis treated with bilastine 20 mg compared to those treated with loratadine 10 mg.
Detailed description
This was a prospective randomized double-blinded study, in which patients were recruited from august 2013 until august 2014. Outpatients attended in 4 otolaryngology clinics from Criciúma, state of Santa Catarina, Brazil were invited to participate of the study. They were aged between 18 and 63 years. Seventy-three patient were included, of whom 36 were treated with loratadine 10 mg and 37 with bilastine 20 mg with medication administered once a day for ten days. The primary outcome was quality of life, assessed by the modified Rhinoconjunctivitis Quality of Life Questionnaire (RQLQm), which was applied at baseline and after 10 days of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilastine group | Experimental | Drug: BilastineBilastine 20 mg administered once a day for ten days. |
| Loratadine group | Experimental | Drug: LoratadineLoratadine 10 mg administered once a day for ten days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- clinical diagnosis of allergic rhinitis (a typical history of rhinitis symptoms: coryza, sneezing, nasal obstruction, nasal itching, and eye symptoms, and hypersensitivity tests for specific IgE measured by Radioallergosorbent Test (RAST) or skin tests
- patients classified as with intermittent rhinitis (symptoms during less than 4 days per week) or persistent rhinitis (symptoms during more than 4 days per week) of moderate to severe intensity (annoyance impairing the quality and quantity of sleep and interfering with daily activities)
Key exclusion criteria (10 listed)
- pregnancy or breast-feeding;
- non-allergic rhinitis (vasomotor, infectious or drug-induced);
- known hypersensitivity to antihistamines;
- clinical disorders that might affect the assessment;
- nasal diseases that could lead to complete blockage or one of the nostrils blockage, such as tumors or septal deviation;
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 |
|---|---|---|
| BilastineAlso: Alektos | Drug | Bilastine group |
| LoratadineAlso: Claritin, Histadin, Loranil, Loritil | Drug | Loratadine group |
Primary outcome
Quality of life in patients with allergic rhinitis
Time frame: 10 days
Application of the modified Rhinoconjunctivitis Quality of Life Questionnaire (RQLQm)
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 7 May 2018.
- Background: PubMed 10452758Juniper EF, Thompson AK, Ferrie PJ, Roberts JN. Validation of the standardized version of the Rhinoconjunctivitis Quality of Life Questionnaire. J Allergy Clin Immunol. 1999 Aug;104(2 Pt 1):364-9. doi: 10.1016/s0091-6749(99)70380-5.
- Background: PubMed 22686617Carter NJ. Bilastine: in allergic rhinitis and urticaria. Drugs. 2012 Jun 18;72(9):1257-69. doi: 10.2165/11209310-000000000-00000.
- Background: PubMed 11674923Nascimento Silva M, Naspitz C, Sole D. Evaluation of quality of life in children and teenagers with allergic rhinitis: adaptation and validation of the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Allergol Immunopathol (Madr). 2001 Jul-Aug;29(4):111-8. doi: 10.1016/s0301-0546(01)79042-8.
- Background: 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.
- Background: PubMed 10848909Van Cauwenberge P, Juniper EF. Comparison of the efficacy, safety and quality of life provided by fexofenadine hydrochloride 120 mg, loratadine 10 mg and placebo administered once daily for the treatment of seasonal allergic rhinitis. Clin Exp Allergy. 2000 Jun;30(6):891-9. doi: 10.1046/j.1365-2222.2000.00914.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.
Jane da Silva, PhD principal investigator
Universidade do Sul de Santa Catarina
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bilastine and Loratadine in people with Allergic Rhinitis, run by Universidade do Sul de Santa Catarina.
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 10 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 7 May 2018. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Quality of life in patients with allergic rhinitis (time frame: 10 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 NCT02513290, which also lists 5 linked publications.
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 7 May 2018.